Blood and Lymph Conditions

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Lymphedema

Breast Neoplasms

Breast Cancer Lymphedema

Breast Diseases

Skin Diseases

Lymphatic Diseases

Postoperative Complications

Complex Physical Therapy plus Pressotherapy during three weeks

Complex Physical Therapy plus Pressotherapy

Kinesio Taping

Violeta Pajero Otero, MRes

This crossover study compares two different treatment techniques for Breast Cancer-Related Lymphedema: 1. Complex Physical Therapy plus Pressotherapy.

2. Kinesio Taping.

Breast Cancer-Related Lymphedema (BCRL) tends to progress in stage and grade if it is not treated.

Complex Physical Therapy (CPT), that includes Manual Lymph Drainage + Multilayer Bandage + Self-care, is the most used technique in order to join the benefits of each technique by the lack of great results with only one technique. The most volume reduction found in a study was achieved combining CPT and Pressotherapy(P). On the other hand, the use of Kinesio Taping (KT) for BCRL has been spreading lately although its clinical efficacy has not been determined by high quality studies.

GOALS:

Main objective: To analyze the effectiveness in the reduction of BCRL volume with KT versus CPT+P in patients attended at the rehabilitation service at HU12Octubre.

Secondary objectives:

To analyze possible changes after each therapy in:

* DASH (Disability Arm, Shoulder and Hand) outcome measure score.
* TTDL (textile therapeutic device for lymphedema) questionnaire score (a quality of life questionnaire for patients with breast cancer-related upper lymb lymphedema using textile therapeutic device that has been validated previously).
* Symptoms associated with BCRL (pain, heaviness, pressure and hardness) using visual analogue scale (VAS).
* Goniometry of Upper Limb.

METHODOLOGY OF THE STUDY:

Design: crossover trial, with a 3-month washout period between both treatment phases. Open design: it is impossible during the treatment to blind physiotherapists and patients, due to the observable differences between both therapies neither during their application nor in the hours after their removal, by the marks left in the skin. The statistical analysis will be supervised by staff of the Clinical Research Unit-Clinical Trials (i+12) of HU12Octubre with the variables coded to blind the analyst.

Interventions: The two therapies compared are:

* CPT+ P.
* KT. Sample size: a sample of 50 patients (25 in each group) was calculated. Subjects of study and randomization: An initial computerized randomized sample was generated among the patients who had attended the Breast Pathology Rehabilitation visit at HU12Octubre during the previous year and who met the eligibility criteria and they were randomly assigned to the groups.

3-month previous washout period; 3-week treatment phases; 3-month washout period between both treatment phases.

Open design: it is impossible during the treatment to blind the physiotherapists and patients, due to the observable differences between both therapies both during their application and in the hours after their removal, by the marks that leave in the skin.

Interventions: The two therapies compared are:

* CPT+ P.
* KT.

The statistical analysis will be supervised by staff of the Scientific Support Unit: Epidemiology and Biostatistics (i+12), Hospital Universitario 12 de Octubre with the variables coded to blind the analyst.

Comparison of Techniques for Breast Cancer-Related Lymphedema.

Complex Physical Therapy Plus Pressotherapy Versus Kinesio Taping in Breast Cancer-Related Lymphedema. Randomized Crossover Trial.

Time since axillary surgery in years at the beginning of the study.

Lymphadenectomy or Sentinel Lymph Node Biopsy.

Truncated Cone Formula for Volume from upper limb circumference.

Validated questionnaire about Disability of the Arm,Shoulder and Hand.

a quality of life questionnaire for patients with breast cancer-related upper lymphedema using textile therapeutic device validated previously (not yet published).

The weight in kilograms divided by the square of the height in metres (kg/m2).

Hospital Universitario 12 de Octubre

University of Castilla-La Mancha

Violeta Pajero Otero

Physiotherapist at the Mammary Pathology Unit

Neoplasm Metastasis

Experimental group: 30 minutes and one hour maximum time of manual lymphatic drainage and compression bandaging with multilayer inelastic bandages with low extensibility. It is possible to apply bandages two or three times per week. Also, an elastic bandage is also held in hand fingers with slight compression and other protective bandage is used in skin. The treatment will be carried out for six weeks five days a week

Control group: 30 minutes and one hour maximum time of manual lymphatic drainage. The treatment will be carried out for six weeks five days a week.

30 minutes and one hour maximum time of manual lymphatic drainage and compression bandaging with multilayer inelastic bandages with low extensibility. It is possible to apply bandages two or three times per week. Also, an elastic bandage is also held in hand fingers with slight compression and other protective bandage is used in skin. The treatment will be carried out for six weeks five days a week

Multimodal treatment: compression bandaging and manual lymph drainage.

30 minutes and one hour maximum time of manual lymphatic drainage. The treatment will be carried out for six weeks five days a week.

Manual lymph drainage

Martín-Valero R., Ph D

Lymphedema is the result of accumulation of fluid and other elements in tissue spaces because of an imbalance between the production of fluid interstitial and transport. Lymphedema can cause significant physical and psychological morbidity. Prevalence of lymphedema in patients after breast cancer surgery is 12-60% and the incidence is 12-26%.Psychological and social consequences of secondary lymphedema related breast cancer have been little recognized and documented. Although, it have performed many studies related secondary lymphedema it not found sufficient evidence in the literature to suggest the most effective treatment. There is some evidence suggesting that compression therapy and manual lymphatic drainage can improve lymphedema but more studies are needed. The aim of this research is to to evaluate the clinical effect of multimodal treatment (compression bandaging and manual lymph drainage) versus applying manual lymphatic drainage in women with arm lymphedema after breast cancer surgery.

This study has two sub research: a quantitative approach and a qualitative approach. The research will be carried out by a multicenter way

Quantitative approach consist in carried out a single-blind randomized controlled trial of 44 women with arm lymphedema. Patients will be distributed in two intervention groups by a randomized way. Participants will be given his assignment by closed envelope. Both treatments will be administered five days a week for six weeks. The experimental group (n=22) will receive multimodal treatment: combination of manual lymphatic drainage and compression bandaging. The control group (n=22) only will receive manual lymphatic drainage. We want to determinate the effect on volume arm decrease, quality of life, level of hand strength, degree of pain, fatigue level, and state of anxiety and depression. The influence on the lymphedema will be analyzed with lower limbs strength, physical activity, lung function, respiratory muscle strength by maximal inspiratory and expiratory pressure measurements (MIP and MEP) and cardiorespiratory functional capacity. Patients adherence will be analyzed by a smartphone.

Qualitative apprach: to know the perceptions and experiences of the participants in both interventions groups through a qualitative descriptive study. Data will be obtained with semi-structured depth interview.

Compression Bandaging and Manual Lymph Drainage in Women With Lymphedema

Effectiveness of the Combination of Compression Bandaging and Manual Lymph Drainage in Women With Secondary Lymphedema After Breast Cancer.

Arm volume is measured with perimetry through truncation of cones formula

Handgrip strength will be determined using hydraulic hand dynamometer "JAMAR"

Multiple sit-to-stant test will be used to evaluate lower limbs strength.

The degree of pain in the affected side with lymphedema will be measured by digital algometer "Commander ™"

Simple spirometry to measure lung function with a spirometer "DATOSPIR120"

The strength of the respiratory muscles is measured through a digital manovacuometer (DATOSPIR120)

Cardiorespiratory functional capacity as measured with six-minute walking test.

FACT-B+4 questionnaire to measure quality of life in patients with breast cancer and lymphedema. Alpha of cronbach: 0,52-0,92

EORTIC-QLQ-C30 questionnaire measures the quality of life in cancer. Alpha of cronbach: 0,52 y 0,89

QLQ BR23 questionnaire to know quality of life in patients with breast cancer. Alpha of cronbach: 0,48 y 0,94

HADS questionnaire to measure depression and anxiety. Alpha of cronbach: 0´8-0´76

QuickPIPPER questionnaire measures the level of fatigue in breast cancer. Alpha of cronbach: 0,730- 0,961

The short version of the IPAQ questionnaire for physical activity level. Alpha of cronbach: 0,75

Data collection was carried out through an interview in-depth semi-structured. The dimensions of the study were developed based on bibliography and objectives of the study: perceptions and experiences with multimodal treatment, ways of living with lymphedema, life style, Physical activity and exercise.

Smartphone-based application to analyze the treatment adherence of the participants

University of Malaga

Ph D

Head and Neck Neoplasms

Fibrosis

Facies

Manuel lymph drainage, compression mask, exercises and skin care

Self-manuel lymph drainage and home exercises

MLD was administered 5 days a week for 4 weeks, with each session lasting 30 minutes \[25\]. Compression therapy was applied to the patients by wearing a compression mask (FM Velcro Fastener, LIPOELASTIC), made of polyamide, cotton, viscose, and elastane, that covered the submandibular region, the masseter region, and the neck. The compression mask is specifically designed for the healing and recovery of tissues after plastic and aesthetic surgeries. The patients were advised to wear the compression masks for at least 4-6 hours per day for 4 weeks and gradually increase wearing time according to their tolerance. The patients were asked to perform skin care by themselves. Skin care was applied using a low pH skin lotion to moisturize the skin. Neck, face/mimic, tongue, and posture exercises were performed by patients while the compression mask was worn and under the supervision of a physiotherapist, with 10 repetitions 5 times a week for 4 weeks.

Complex decongestive physiotherapy

Self-MLD and exercises (neck, face/mimic, tongue, and posture exercises) were shown to the patients in this group. Self-MLD included self-administered lymph drainage of the axillary, posterior, lateral, and anterior neck areas; the pre- and retro-auricular regions; the lateral and anterior regions of the face; and the lower jaw region. Then the order is reversed back to the starting point \[3\]. A video of self-MLD and a text including exercise descriptions were shared with patients and their relatives to ensure that the self-MLD and exercises were performed accurately and regularly at home. Self-MLD was recommended to be applied once a day, and the exercises were advised to be performed for 10 repetitions each, 10 times a day for 4 weeks. The patients were called by phone during the second week after their first evaluation as a control and to motivate the patient for performing self-MLD and home exercises properly.

Home program

The aim of this study was to determine the effects of complex decongestive physiotherapy (CDP) and home programs on internal/external lymphedema, staging, fibrosis, and three-dimensional (3D) surface scanning and volume evaluation in head and neck lymphedema. Twenty-one patients were randomly divided into three groups: CDP; home program including self manual lymph drainage (MLD) and exercises; and control. CDP included MLD drainage, compression, exercise, and skin care. Self-MLD and exercises were performed by home program group patients. Assessment methods were applied at baseline and 4 weeks later for all groups. MD. Anderson Cancer Center Head and Neck Lymphedema Protocol was implemented to evaluate head and neck external lymphedema, staging, and fibrosis. An Artec Eva 3D scanner and the Autodesk ReCap Photo Studio software were used to determine and calculate the volume of the head and neck region via 3D surface scanning. Head and neck external lymphedema and fibrosis assessment criteria were performed to evaluate visible soft tissue edema and the degree of stiffness. To assess internal lymphedema, Patterson's scale was applied using fiber-optic endoscopic imaging.

Head and neck cancer (HNC) have been seen in 13.3/100,000 males and 2.8/100,000 in females in Turkey. HNC related treatments such as lymph node dissection, tumor excision, chemotherapy, radiotherapy, and cancer itself can cause head and neck lymphedema (HNL). The incidence of HNL due to HNC treatments (surgery, chemotherapy and chemoradiation) has been reported to be between 48% and 90%.

A recognition of HNL has been growing in recent years, but HNL is still much less recognized than upper and lower limb lymphedema and is easily ignored by both patients and health care providers. Therefore, in many cases, the diagnosis and treatment of HNL may be delayed, or patients cannot access treatment. In routine practice, after HNC, the self-absorption of HNL is generally expected. Clinical experiences have confirmed that HNL develops 2-6 months after cancer treatment and regresses in some patients over time.

A variety of physiotherapy approaches have been shown to prevent and minimize physical, functional, emotional, and social disorders resulting from HNL. However, complex decongestive physiotherapy (CDP) is considered a gold standard treatment method for lymphedema. This method consists of manual lymph drainage (MLD), skin care, compression therapy, and therapeutic exercises. Although there are many studies about the effects of CDP on upper and lower limbs, there is only a limited number of studies about HNL and CDP in the literature.

Two Different Physiotherapy Programs in Lymphedema Following Head and Neck Cancer Treatment

To Investigate the Effectiveness of Two Different Physiotherapy Programs in Lymphedema Following Head and Neck Cancer Treatment

Patterson's scale is the most comprehensive scale for evaluating internal HNL. It is a fiber-optic endoscopic imaging method applied by an otolaryngologist to assess the gaps in the pharynx and larynx with regard to edema. Also, 11 different structures (base of tongue, posterior pharyngeal wall, epiglottis, pharyngoepiglottic folds, aryepiglottic folds, interarytenoid space, cricopharyngeal prominence, arytenoids, false vocal folds, true vocal folds, anterior commissure) and two spaces (vallecula and pyriform sinus) are rated as normal, mild, moderate, or severe during the inspection \[26\].

The MD Anderson Cancer Center HNL standard evaluation protocol includes two facial circumference measurements and nine point-to-point tape measurements between the reference points on the face \[27\].

Seven key facial measurements were totaled to form a composite facial score. In addition, composite neck score was obtained by performing circumference measurements from three different regions of the neck \[27\].

In order to clinically determine the development of external HNL, a reduction in the lymphedema stage or a minimum 2% reduction was required in absolute values in composite measurements that were equivalent to a change of at least 2 cm \[2, 28\].

The MD Anderson Cancer Center HNL rating scale was based on the traditional Földi's scale, which is used for staging limb lymphedema and determining the severity \[3\]. The only difference between the MD Anderson Cancer Center HNL rating scale and Földi's scale is that Stage 1 is divided into Stage 1a and Stage 1b on Földi's scale. Stage 0 demonstrates lymphedema without visible edema but with a complaint of tissue heaviness. Stage 1a represents soft visible edema without pitting and which is reversible. Stage 1b shows soft pitting edema, which remains reversible. Stage 2 displays firm pitting edema, which is irreversible but lacks tissue changes. Stage 3 lymphedema, the most severe of all stages, represents irreversible tissue changes such as hyperkeratosis or papillomatosis \[27\].

The HNC related external lymphedema and fibrosis assessment criteria were used to evaluate the parameters, including the presence of visible soft tissue edema, the degree of stiffness of the tissues involved, and the severity of the lymphedema on the left periorbital region, right periorbital region, left cheek, right cheek, and submental region. This scale was used for rating the tissue under four headings for each region: Type A, Type B, Type C, and Type D. Next, each type other than Type A was graded as mild, moderate, and severe \[29\].

This evaluation was applied with an Artec Eva 3D scanner. The measurements and analyses were performed for seven different anatomical reference points. Seven markers were used to facilitate the calculation of the volume of the face and neck following the 3D scanning of the face and neck area; the data obtained were transferred to computer. After the scan was completed, a pattern atlas was created using the Autodesk ReCap photo software for the data on image, geometry, and texture. Finally, the predetermined reference points were combined, and the volume of the remaining portion was calculated by the volume of the 3D network representing the scanned geometry. In addition, the properties of the object were calculated using MESHLAB software.

Gazi University

Izmir Bakircay University

Head of Geriatric Rehabilitation Department

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nocturia

Polyuria

Urogenital Neoplasms

Lower Urinary Tract Symptoms

Urological Manifestations

Urination Disorders

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Skin care, exercise and compression stocking:

The patient has to wear custom-made compression thigh stocking(s) in case of unilateral/ bilateral swelling of the leg and has to wear a bermuda in case of swelling of the midline region. The patient continues the skin care and continues/ restarts exercise therapy with the home physical therapist 2 times a week. Frequency of exercises is gradually decreased: M1-3 2x/w, M4-6 1x/w, M7-9 1x/M; M10-12 only self-exercises.

Usual care + manual lymph drainage. Manual lymph drainage is performed by the home physical therapist. Every session lasts for 30 minutes.

Frequency of manual lymph drainage is gradually decreased: M1-3 2x/w, M4-6 1x/w, M7-9 1x/M; M10-12 only self-MLD.

skin care, exercise and compression stocking

Usual care

Nele Devoogdt, Prof. Dr.

Charlotte Van Calster, MSc.

After the treatment of urogenital cancer, a person may develop lymphoedema of the leg(s) and/ or midline region. Lymphoedema is the result of a dysfunction in the lymphatic system and is characterized by excessive retention of lymphatic fluid in the interstitial compartment, adipose deposition and chronic tissue inflammation resulting in fibrosis. Clinical symptoms include abnormal tissue swelling, sensation of limb heaviness, erythema, pain, and impaired limb function.

The added value of manual lymph drainage, applied in patients with mild (early) lower limb lymphoedema and in addition to skin care, exercises and a compression stocking, has never been investigated.

Therefore, the objective of this randomised controlled pilot trial is to investigate the feasibility of a trial about the added value of manual lymph drainage (to skin care, exercises and wearing compression stocking) in patients with mild (early) lower limb lymphoedema. In fact, the investigators want to determine the sample size for a trial investigating the effectiveness of MLD and want to investigate the feasibility of the study design.

Lymphoedema and Nocturia/ Nocturnal Polyuria After Pelvic Lymph Node Dissection for Urogenital Cancer

Lymphoedema and Nocturia/ Nocturnal Polyuria After Pelvic Lymph Node Dissection (LND) for Urogenital Cancer: Randomised Controlled Trial (Pilot)

Lymphoedema-specific quality of life will be evaluated using the Lymph-ICL-LL questionnaire: The Lymph-ICF-LL is a descriptive, evaluative tool containing 28 questions about impairments in function, activity limitations, and participation restrictions in patients with lower limb lymphoedema. The questionnaire has 5 domains: physical function, mental function, general tasks/household activities, mobility activities, and life domains/social life.

Volume measurements will be done at midline, leg and foot. Volume midline: circumference at the level of the hip and distance navel - pubic bone, with tapeline.

Volume leg: circumference measurements in sitting position, with knee extension, foot supported by chair; reference point is the upper border of the patella and every 4cm up to the groin and to the ankle, with perimeter Volume foot: figure of 8 method: in sitting position, with knee extension, foot supported by chair and relaxed; with tapeline; make the figure 8 between the distal part of medial and lateral malleolus and the proximal border of metatarsal I and V

Health-related quality of life will be assessed with the EuroQol EQ-5D-5L (questionnaire).

The EQ-5D, developed by the EuroQol Group, is a generic HRQoL instrument commonly used for indirect utility measurement. It is a descriptive system for health states, encompassing 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), combined with a visual analogue scale ranging from "worst imaginable health state" to "best imaginable health state". Each health dimension has 5 levels of severity (EQ-5D-5L;5L: no problems, slight problems, moderate problems, severe problems,extreme problems /unable to).

Each EQ-5D health state is labelled by a code, e.g. 21531, where each digit represents the severity level of a dimension. By convention, the order of dimensions is mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

Physical activity will be assessed with the International Physical Activity Questionnaire (IPAQ).

The IPAQ is a 27-item self-reported measure of physical activity for use with individual adult patients aged 15 to 69 years old.

Water content in the leg and midline region will be measured using the MoistureMeterD Compact.

Extracellular fluid in the lower limb will be measured with bio-impedance spectroscopy.

Body weight will be measured with an electronic balance

Number of infection episodes during the previous 6 months is questioned

Number of patients accepting to participate in the randomized controlled pilot trial

If the participant is randomised to the intervention group with manual lymph drainage, information is collected regarding the type of lymph drainage, the number of sessions and the duration of one session.

Difficulties concerning the intervention will be registered

The number of drop-outs in both the experimental as the control group

Universitaire Ziekenhuizen KU Leuven

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dimenhydrinate

Information, skin care, compression therapy, exercises and fluoroscopy-guided MLD 3 weeks (14 sessions of 60 minutes) of intensive treatment 6 months (18 sessions of 60 minutes) of maintenance treatment 6 months of follow-up

Information, skin care, compression therapy, exercises and traditional MLD 3 weeks (14 sessions of 60 minutes) of intensive treatment 6 months (18 sessions of 60 minutes) of maintenance treatment 6 months of follow-up

Information, skin care, compression therapy, exercises and placebo MLD 3 weeks (14 sessions of 60 minutes) of intensive treatment 6 months (18 sessions of 60 minutes) of maintenance treatment 6 months of follow-up

During intensive phase: a leaflet with information about the lymphatic system and lymphoedema, clinical evaluation and conservative treatment of lymphoedema During maintenance phase: two informational sessions about self-management and about compression sleeves and other compression material

Information

The skin is hydrated during the session. If wounds are present, the wound is cared.

Skin care

During intensive phase: application of multi-layer, multi-component bandages During maintenance phase: wearing custom-made compression garment

Compression therapy

Fluoroscopy-guided MLD is applied on patient-specific lymphatic system (known from lymphofluoroscopy) by applying cleaning techniques on lymph nodes, resorption techniques to stimulate resorption of lymph by lymph capillaries and gliding technique to stimulate transport of lymph through lymph collectors

Fluoroscopy-guided MLD

Traditional MLD is applied without knowledge of the patient-specific lymphatic architecture. During MLD no cream or oil is used. A pressure with the hands up to 40 mmHg is applied. Drainage is performed at the level of the jugular and occipital region and the belly (in the depth). Draining techniques are applied on the retroclavicular lymph nodes, axillary lymph nodes, humeral lymph nodes and cubital lymph nodes. At the level of the hand, arm, shoulder and trunk, hand movements are applied to stimulate lymphatic transport through the lymph collectors. The therapist's hands perform 'pumping-movements' while stretching the skin.

Traditional MLD

During placebo MLD a superficial massage with massage cream is performed on the patient's contralateral arm and on the belly.

Placebo MLD

Nele Devoogdt, PhD

The main scientific objective of this multicentric double-blinded randomised controlled trial entails examining the effectiveness of fluoroscopy-guided MLD versus traditional MLD versus placebo MLD, applied as part of the intensive and maintenance phase of Decongestive Lymphatic Therapy, for the treatment of BCRL Secondary scientific objectives entail examining the relationship between different variables of lymphoedema at baseline

According to the International Society of Lymphology, lymphoedema needs to be treated with Decongestive Lymphatic Therapy (Consensus Document ISL 2013). This is a two-stage treatment programme. During the first or intensive phase, lymphoedema has to be maximally reduced. This phase consists of skin care, manual lymph drainage (MLD), multi-layer bandaging and exercise therapy. The second or maintenance phase aims to conserve and optimise the results obtained in the first phase. It consists of skin care, compression by a low-stretch elastic sleeve, exercises and lymph drainage. Skin care, multi-layer bandaging, elastic sleeve and exercises are treatment modalities that (after instructing the patient) can be performed by the patient herself. MLD has to be applied by a physical therapist and hence entails a big financial cost for the patient and the Health Care (Kärki et al 2009). The effectiveness of MLD applied during the intensive phase has been investigated by 5 randomised controlled trials, but there is conflicting evidence. So, further investigation is warranted to determine the relative benefit of MLD. The effectiveness of MLD applied during the maintenance phase has never been investigated (Devoogdt et al 2010, Oremus et al 2012, Huang et al 2013, Ezzo et al 2015).

A possible explanation why MLD is not obviously proven to be effective, is that MLD is applied in an inefficient way: during MLD, hand manoeuvres are applied on all lymph nodes and lymphatics that may be anatomically present. After axillary dissection and/ or radiotherapy (for the treatment of breast cancer), the lymphatic system is damaged: lymph nodes are removed and often fibrosis of the superficial lymphatic system occurs. As a result, rerouting of the lymphatic drainage occurs. Rerouting is patient-specific, consequently, it is possible that the traditional MLD needs be abandoned and a tailored approach needs to be established. Lymphofluoroscopy can aid to apply a more efficient MLD. During lymphofluoroscopy, a fluorescent substance is injected subcutaneously in the hand and it visualizes the transport of lymph from the hand up to the axilla and it demonstrates alternative pathways towards other lymph nodes.

A second explanation why the traditional method of MLD is not proven to be effective, is that research has shown that MLD with high pressure (vs low pressure) is more effective to improve lymph transport, as well as gliding (vs no gliding). During the new method of MLD (or fluoroscopy-guided MLD), the therapist only performs hand movements on functional lymphatics and lymph nodes. In addition, the hand movements are applied with higher pressure and lymph transport through the lymph collaterals is stimulated by applying strikes across the skin.

Therefore, the main scientific objective entails examining the effectiveness of fluoroscopy-guided MLD versus traditional MLD versus placebo MLD, applied as part of the intensive and maintenance phase of Decongestive Lymphatic Therapy, for the treatment of BCRL

Effectiveness of Fluoroscopy-guided MLD for Treatment of BCRL

Effectiveness of Fluoroscopy-guided Manual Lymph Drainage (MLD) Versus Traditional MLD or Placebo MLD, as Part of Decongestive Lymphatic Therapy, for the Treatment of Breast Cancer-related Lymphoedema (BCRL): a Randomised Controlled Trial

= the ratio at the different time points; The (inter-limb) ratio = Relative excessive lymphoedema volume of the arm/ hand = \[(volume arm + volume hand affected side) / (corrected volume arm + corrected volume hand healthy side)\]; Volume arm is determined by performing circumference measurements and calculating the volume with the formula of the truncated cone; Volume hand is determined by the water displacement method; The volume of the non-dominant hand/arm is on average 3.3% smaller than the dominant hand/arm, therefore is the volume of the arm at the healthy side corrected for hand dominance

Ratio PWC% at the different time intervals

= PWC% affected side / PWC% healthy side Measured with the MoistureMeterD compact at the level of shoulder and trunk where after a mean ratio PWC% is calculated

L-Dex score, measured with Impedimed BIS device at the different time points Amount of extracellular fluid = represented by L-Dex score This outcome is calculated and displayed on the Impedimed BIS device, and represents the difference in the amount of extracellular fluid in the affected upper limb compared to the unaffected upper limb. Normal L-Dex scores range between -10 and +10. A score outside this range, represents lymphedema. A higher number, represents a worse score.

Analyses for change in thickness of cutis + subcutis were performed:

Relative excessive thickness of the cutis+subcutis (inter-limb ratio of cutis+subcutis in mm) = Thickness of cutis+subcutis (mm) affected side / thickness of cutis+subcutis (mm) healthy side Arm: Reference points 1, 2, 3, 5, 6, 7 where after a mean ratio thickness of cutis+subcutis is calculated

Different scores are obtained from the questionnaire. Each of the 29 questions has to be scored on a 11-point Likert scale between 0 and 10 (instead of a VAS between 0 and 100). The total score of the Lymph-ICF-UL is equal to the sum of the scores on the questions divided by the total number of answered questions and multiplied by 10. In addition, a score is determined for each of the five domains of the Lymph-ICFUL: (1) physical function, (2) mental function, (3) household activities, (4) mobility activities, and (5) life and social activities.

Thus, the total score on the Lymph-ICF-UL and the score on the five domains range between 0 and 100. The higher the score, the more problems in functioning.

Induration force is presented in Newton (N) by the device. Relative difference in skin elasticity (induration force inter-limb ratio) = Skin elasticity affected side / skin elasticity healthy side Arm: Reference points 1, 2, 3, 5, 6, 7 where after a mean induration ratio is calculated

At the end of each assessment, subjects are asked to fill in the questionnaire individually Questionnaire counts 16 + 1 questions, which relate to the following 5 domains: physical symptoms; physical wellbeing, psychological symptoms; existential wellbeing and support A Likert scale with 11 possibilities (0-10) is used for the 16 questions and part D is an open question Each question corresponds to a score between 0 (very bad) and 10 (excellent); a total score and 5 different domain scores are calculated (each between 0 and 10) A lower score indicates a lower Quality of Life

At each clinical evaluation, it was asked to the patient if they had had an episode of erysipelas (which is an infection) between today and the previous evaluation.

The numbers of episodes were counted, and the causes of this episode of erysipelas were described. The numbers of episodes were compared between the groups.

The number patients presented as a percentage that indicated that their complaints have been slightly (3), much (2) or very much improved (1) during 12 months of time

The mean rating of the perceived effect of the manual lymph drainage (MLD) that patients received during the study (between 0-10). The higher the score, the higher the satisfaction about the effect of the manual lymph drainage received.

Ratio PWC% at the different time intervals

= PWC% affected side / PWC% healthy side Measured with the MoistureMeterD compact at different measurement points where after a mean ratio PWC% is calculated Arm: Reference points 1, 2, 3, 5, 6, 7 where after a mean ratio PWC% is calculated

In total, six reference points (located at the hand (1 reference point) and arm (5 reference points)) are being evaluated and scored (0 or 1) A reference point is scored with 1 in case the skin fold thickness at the affected side is increased compared to the reference point at the non-affected side The final outcome for the arm score is the (cumulated) total score of six reference points 1, 2, 3, 5, 6, 7 (range 0-6), a higher score indicates more presence of thickened skin

In total, six reference points (located at the hand (1 reference point) and arm (5 reference points)) are being evaluated and scored (0 or 1) A reference point is scored with 1 in case fibrosis of the skin is present The final outcome for the arm score is the (cumulated) total score of six reference points 1, 2, 3, 5, 6, 7 (range 0-6), a higher score indicates more presence of fibrosis

1. Total dermal backflow score (0-39). The higher the score, the more dermal backflow is present
2. Amount of efferent lymphatics leaving dermal backflow areas
3. Presence of visible lymph nodes after the break

Raw data is currently still being analyzed in order to be able to report on the described outcome measures. At present (March 2022) these analyses are not yet performed. Therefore these results will be reported later on this year (anticipated date: July 2022).

Agentschap voor Innovatie door Wetenschap en Technologie

Information, skin care, compression therapy, exercises and fluoroscopy-guided MLD 3 weeks (14 sessions of 60 minutes) of intensive treatment 6 months (18 sessions of 60 minutes) of maintenance treatment 6 months of follow-up

Information: During intensive phase: a leaflet with information about the lymphatic system and lymphoedema, clinical evaluation and conservative treatment of lymphoedema During maintenance phase: two informational sessions about self-management and about compression sleeves and other compression material

Skin care: The skin is hydrated during the session. If wounds are present, the wound is cared.

Compression therapy: During intensive phase: application of multi-layer, multi-component bandages During maintenance phase: wearing custom-made compression garment

Fluoroscopy-guided MLD: Fluoroscopy-guided MLD is applied on patient-specific lymphatic system (known from lymphofluoroscopy) by applying cleaning techniques on lymph nodes, resorption techniques to stimulate resorption of lymph by lymph capillaries and gliding technique to stimulate transport of lymph through lymph collectors

Information, skin care, compression therapy, exercises and traditional MLD 3 weeks (14 sessions of 60 minutes) of intensive treatment 6 months (18 sessions of 60 minutes) of maintenance treatment 6 months of follow-up

Information: During intensive phase: a leaflet with information about the lymphatic system and lymphoedema, clinical evaluation and conservative treatment of lymphoedema During maintenance phase: two informational sessions about self-management and about compression sleeves and other compression material

Skin care: The skin is hydrated during the session. If wounds are present, the wound is cared.

Compression therapy: During intensive phase: application of multi-layer, multi-component bandages During maintenance phase: wearing custom-made compression garment

Traditional MLD: Traditional MLD is applied without knowledge of the patient-specific lymphatic architecture. During MLD no cream or oil is used. A pressure with the hands up to 40 mmHg is applied. Drainage is performed at the level of the jugular and occipital region and the belly (in the depth). Draining techniques are applied on the retroclavicular lymph nodes, axillary lymph nodes, humeral lymph nodes and cubital lymph nodes. At the level of the hand, arm, shoulder and trunk, hand movements are applied to stimulate lymphatic transport through the lymph collectors. The therapist's hands perform 'pumping-movements' while stretching the skin.

Information, skin care, compression therapy, exercises and placebo MLD 3 weeks (14 sessions of 60 minutes) of intensive treatment 6 months (18 sessions of 60 minutes) of maintenance treatment 6 months of follow-up

Information: During intensive phase: a leaflet with information about the lymphatic system and lymphoedema, clinical evaluation and conservative treatment of lymphoedema During maintenance phase: two informational sessions about self-management and about compression sleeves and other compression material

Skin care: The skin is hydrated during the session. If wounds are present, the wound is cared.

Compression therapy: During intensive phase: application of multi-layer, multi-component bandages During maintenance phase: wearing custom-made compression garment

Placebo MLD: During placebo MLD a superficial massage with massage cream is performed on the patient's contralateral arm and on the belly.

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Belgium

Region of Enrollment

Body Mass Index

Prof. Nele Devoogdt

Baseline

Post intensive treatment phase

At the post-intensive assessment, 5 patients dropped-out of which 4 patients (2%) were lost to follow-up.

Lymphoedema Volume at the Level of the Arm/ Hand

Post intensive phase

Stagnation of Fluid at Level of the Shoulder/ Trunk

Post-intensive

1M maintenance

3M maintenance

6M maintenance

6M follow-up

At the post-intensive assessment, 5 patients dropped-out of which 4 patients (2%) were lost to follow-up. At the end of the maintenance phase (P6), only 3 additional patients (1.5%) were lost to follow-up. At the end of the follow-up phase (P12), one additional patient was lost to follow-up (12 patients in total since baseline or 6%).

Extracellular Fluid in the Upper Limb

Thickness of Cutis and Subcutis of Arm and Trunk Measured With Ultrasound

Problems in Functioning Related to Development of Breast Cancer-related Lymphoedema

Post-intensive treatment

Elasticity of Skin and Subcutaneous Tissue of Arm and Trunk Using the SkinFibrometer

Quality of Life Score

between baseline and the end of the follow-up phase,12 patients were lost-to-follow up in total (or 6%).

Number of Episodes of Erysipelas

Overall Treatment Satisfaction

Manual Lymphatic Drainage (MLD)-Specific Treatment Satisfaction

Local Tissue Water at the Level of the Arm and Trunk

Thickness of the Cutis and Subcutis of the Arm and Trunk Evaluated by Palpation (Pinch Test)

Hardness (Fibrosis) of the Skin at the Level of the Arm and Trunk Evaluated Through Palpation

Lymphatic Architecture and Function

Overall Study

Combined physiotherapy

Compression bandaging

Michael J Bernas, MS

The purpose of this study is to examine the short-term and long-term efficacy of massage therapy alone compared to massage therapy plus compression bandaging in the treatment of breast cancer treatment-related swelling of the arms and legs.

Massage therapy (in the form of manual lymph drainage \[MLD\]) and compression bandaging (CB) are integral components of combined physical therapy (CPT), the recommended treatment for peripheral lymphedema (LE). According to the World Health Organization, LE afflicts hundreds of millions worldwide and probably millions in the United States. Effects of various forms of massage on lymph circulation have been postulated for more than a century, but the efficacy of MLD alone without CB has not been demonstrated. New data suggest that MLD alone reduces established LE volume as effectively as CB in combination with CPT and minimizes LE development.

Patients will be randomly assigned to either treatment with MLD alone or a combination of MLD and CB. Patients will be treated in 10 one-hour sessions over 2 weeks. They will also undergo lymphangioscintigraphy (a nuclear medicine test) to depict the function of their lymphatic system. Patients will continue self treatment at home and will be followed for 6 months.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of Techniques for Breast Cancer-Related Lymphedema.	NCT03051750	Breast Cancer L...	Complex Physica... Kinesio Taping	18 Years -	Hospital Universitario 12 de Octubre
Comparison of Techniques for Breast Cancer-Related Lymphedema.	NCT03051750	Breast Cancer L...	Complex Physica... Kinesio Taping	18 Years -	Hospital Universitario 12 de Octubre
Compression Bandaging and Manual Lymph Drainage in Women With Lymphedema	NCT02165696	Arm Lymphedema ...	Multimodal trea... Manual lymph dr...	45 Years - 65 Years	University of Malaga
Two Different Physiotherapy Programs in Lymphedema Following Head and Neck Cancer Treatment	NCT04286698	Head and Neck C... Lymphedema of F... Fibrosis; Skin	Complex deconge... Home program	22 Years - 73 Years	Izmir Bakircay University
Lymphoedema and Nocturia/ Nocturnal Polyuria After Pelvic Lymph Node Dissection for Urogenital Cancer	NCT05266157	Lower Limb Lymp... Urogenital Canc...	Manual lymph dr... Usual care	18 Years -	Universitaire Ziekenhuizen KU Leuven
Effectiveness of Fluoroscopy-guided MLD for Treatment of BCRL	NCT02609724	Breast Neoplasm Lymphedema	Information Skin care Compression the... Fluoroscopy-gui... Traditional MLD Placebo MLD	18 Years -	Universitaire Ziekenhuizen KU Leuven
Massage Therapy for Breast Cancer Treatment-Related Swelling of the Arms	NCT00058851	Lymphedema	Manual lymph dr... Combined physio... Compression ban...	-	National Center for Complementary and Integrative Health (NCCIH)
Compression Bandaging and Manual Lymph Drainage in Women With Lymphedema	NCT02165696	Arm Lymphedema ...	Multimodal trea... Manual lymph dr...	45 Years - 65 Years	University of Malaga

Spots Global Cancer Trial Database for manual lymph drainage