Neoplasms

Symptoms and General Pathology

All Conditions

Blood and Lymph Conditions

Neoplasm Metastasis

Facies

Head and Neck Neoplasms

Lymphedema

Lymphatic Diseases

A combination of manual lymph drainage , compression bandaging, physical exercise and a skin care regimen

Complete Decongestive Therapy

Standard of care is currently observation

Observation

Ashley Mays, MD

This will be a prospective, randomized controlled study of \~60 adult patients who have undergone a laryngectomy, neck dissection, maxillectomy or mandibulectomy surgical procedure for the treatment of head and neck cancer at Our Lady of the Lake Hospital and have been referred by their physician for evaluation of head and neck lymphedema while serving as an inpatient. Consenting patients will be evaluated by certified speech and language pathologists trained to ascertain lymphedema severity using a series of visual and tangible measurements immediately following surgery and randomized into two cohorts, one receiving the complete decongestive therapy regimen and the other not receiving this specific combination treatment for their edema. Facial and neck measurements will be taken at baseline following surgery and at several points prior to and at discharge as well as at the 2 week follow up visit to the clinic. Measurements and overall change/reduction in edema will be compared between the cohorts.

BACKGROUND:

Head and neck lymphedema (HNL) is a common and sometimes debilitating complication of head and neck cancer (HNC) treatment. It occurs when the lymphatic system is either overloaded or damaged and cannot clear the high protein lymphatic fluid within the interstitial tissues. This in turn causes inflammation, connective tissue proliferation and overall functional impairment of the lymph system and bodily extremities. The long-term effects that edema can have in the cranio-facial region are not simply a cosmetic nuisance, but can lead to severe functional and psycho-social issues when affecting the lips, tongue, throat, eyes, mouth and neck. The ability to communicate, swallow, breath and see can be greatly impeded by the lymphatic swelling, which clearly affects the quality of life for many patients. Additional deficits may include dysfunction of the arms and shoulders with reduced cervical range of motion. Although lymphedema is well recognized in patients within the fields of urinary, breast and gynecologic cancer, it has only recently been addressed in the area of head and neck cancer.

The therapeutic management of HNL in HNC patients is a growing topic of research, as this condition pushes to the forefront and crosses over multi-disciplinary departments from otolaryngology to cancer therapy to speech and language therapy and rehabilitation. Historically, the technique of manual lymph drainage (MLD), a series of gentle circular massage strokes applied to the skin to increase lymphatic flow has been used. Decades later, the MLD technique was combined with compression bandaging, physical exercises and a skin care regiment to create a complete decongestive therapy (CDT) in the outpatient setting and is now considered to be best practice for outpatient lymphedema treatment at some institutions. The HNL program at M.D. Anderson Cancer Center has also created a series of formal evaluation and treatment techniques which include patient interviews/survey, visual assessment of the cranio-facial, neck and shoulder areas, functional assessments of communication and swallowing, photography, tape measurements and staging scales of edema to characterize the appearance and severity of the swelling.

Herein, investigators propose to examine the effects of complete decongestive therapy on head and neck cancer patients at Our Lady of the Lake Regional Medical Center who experience post-surgical head and neck lymphedema after total laryngectomy, neck dissection, maxillectomy or mandibulectomy compared to a control cohort. Investigators aim to assess the improvement of patient outcomes through the use of this technique to reduce cranio-facial edema and compare to those who do not receive CDT in an in-patient setting. Our study is novel in that there is minimal data on the effect of CDT in the acute care setting and in the areas of the head and neck, hence contributing to the growing body of knowledge about this therapy in this acute patient population.

OBJECTIVES:

The objective of of this research study is to assess physical improvements in visual, measureable and functional outcomes in head and neck cancer patients with head and neck lymphedema who have undergone Complete Decongestive Therapy (CDT) as a part of in-patient care at Our Lady of the Lake Hospital and compare this to patients in a control group who do not receive CDT.

STUDY DESIGN:

This will be a prospective, randomized controlled study of \~60 adult patients who have undergone a laryngectomy, neck dissection, maxillectomy or mandibulectomy surgical procedure for the treatment of head and neck cancer and have been referred by their physician for evaluation of head and neck lymphedema while admitted to inpatient care at Our Lady of the Lake Regional Medical Center following surgery. Patients will be evaluated by certified speech and language pathologists trained to ascertain lymphedema severity using a series of visual and tangible measurements immediately following surgery. Specific therapies for speech and language performance are provided beginning 24-72 hours post op per standard of care. At the time of speech therapy, patients will be informed and consented at the hospital bedside about this study. Those that agree to participate will be randomized into a CDT treatment arm or a control arm. The CDT therapy arm will be a combination of manual lymph drainage (MLD), tissue compression or kinesio tape bandaging, remedial exercises and a skin care regiment. This therapy will be administered every time the patient is seen by the speech pathologist, which is typically on a daily basis until discharge. Patients who are randomized into the control arm will not receive the specific CDT, but will still receive any speech or language therapy or other medical treatment services that are standard for their care management plan. Cranio-facial measurements will be taken of both cohorts by a blinded measurer prior to therapy and prior to hospital discharge, after several rounds of CDT have been administered to the patient. Those in the non-CDT cohort will be measured at the day of inpatient consult and again on day of discharge. Changes in the measurements will determine if the CDT has a positive effect on the edema symptoms.

One speech pathologist on the study team will perform the CDT or control therapy and will only be aware of the participant's cohort arm at the time of random assignment. A second speech pathologist will be blinded to the cohort arm and will be responsible for taking the cranio facial measurements for all participants.

Patients will be randomized into one of two groups. Group A will receive the CDT during their inpatient stay. Group B will not receive the CDT. The randomization of the patients into these 2 cohorts will be predetermined by pulling 15 permuted blocks of 4 (Ex. AABB, ABAB, BABB, ABBA, etc) pre-drawn by an individual not involved in the therapy. The permuted blocks will be lined up sequentially (Ex. AABBABABBABBABBA.....) and each letter placed in one of 60 envelopes. The speech pathologist assigned to the patient will pull the next envelope in order to determine if the patient will be in Group A (CDT) or Group B (no CDT) post-surgery. The principal investigator and the individual who will perform the measurements will be completely blinded to the patient's cohort assignment and in this way, minimize investigator bias.

A medical chart review will also be conducted to gather additional variables such as age, gender, race and any prior head and neck cancer medical history.

Double Blind randomization of patients and investigator outcome assessor. Patients that agree to participate will be randomized into a CDT treatment arm or a control arm that does not receive CDT. One speech pathologist on the study team will perform the CDT and will only be aware of the participant's cohort arm at the time of random assignment. The second speech pathologist will be blinded to the cohort arm and will be responsible for taking the cranio facial measurements for all participants to minimize investigator bias.

Complete Decongestive Therapy on Head and Neck Lymphedema

The Effects of Complete Decongestive Therapy on Head and Neck Lymphedema in Post-surgical Head and Neck Cancer Patients (Randomized Control Trial)

Data will be de-identified upon collection

2 % percent change of composite facial measurement

Our Lady of the Lake Hospital

Academic Research Director

Pharmaceutical Solutions

All Drugs and Chemicals

Subjects who present with dermal lymphatic backflow will be asked to complete a session of advanced pneumatic compression therapy each day at home.

Subjects who present with dermal lymphatic backflow will continue under standard-of-care surveillance of lymphedema and will only receive treatment if they are diagnosed with head and neck cancer-acquired lymphedema.

Subjects who do not present with dermal lymphatic backflow at enrollment will be monitored at subsequent visits and if/when dermal lymphatic backflow is observed will be randomized into either Advanced Pneumatic Compression or Standard-of-Care arm.

All subjects will undergo lymphatic imaging at enrollment, 3, 6, and 12 months to assess the extent of dermal lymphatic backflow. Small amounts (0.1 mL) of a solution of indocyanine green (ICG) will be intradermally injected near the ear and along the jaw. Images of the lymphatics will be acquired by shining a dim light on the face and neck and acquiring the resulting fluorescent signal emanating from ICG-laden lymph. Images will be processed to calculate the area of the head and neck that show abnormal dermal lymphatic backflow.

Near-infrared fluorescence lymphatic imaging

The advanced pneumatic compression device (APCD) mimics manual lymphatic drainage, a light massage that stimulates lymphatic uptake and function and frequently prescribed for lymphedema therapy.

advanced pneumatic compression therapy

John Rasmussen, PhD

The goal of this clinical trial is to learn if treating the lymphatics in head and neck cancer survivors before clinical diagnosis of lymphedema will prevent its development or progression. The main questions it aims to answer are:

* Does early lymphatic treatment, before onset of clinical symptoms, prevent the development of head and neck lymphedema?
* Does dermal lymphatic backflow provide an early indication of lymphedema and its response to treatment?

Over the course of one year, participants will undergo several sessions near-infrared fluorescence lymphatic imaging to assess whether they have abnormal dermal lymphatic backflow following head and neck cancer treatment. Subjects will be divided into two groups, a treated and a control group. The treated group will be asked to complete daily sessions of pneumatic compression therapy at home, while the control group will receive standard-of-card treatment after clinical diagnosis of lymphedema. Researchers will compare the incidence of lymphedema between the two groups to see if treatment before diagnosis prevents the development and progression of head and neck lymphedema.

Assessing Impact of Early Physiotherapy on Lymphatic Dysfunction in Head and Neck Cancer Survivorship

Assessing Impact of Early Physiotherapy on Lymphatic Dysfunction in Head and Neck

Results will be published in a scientific journal along with description of protocol. The complete data set includes large (GBs) sequences of images as well as protected health information (faces). Partial, redacted data sets may be sharable upon request.

The incidence of lymphedema between the control and treated groups will be compared.

The change (from enrollment) in the area of the head and neck that is covered by abnormal dermal lymphatic backflow as assessed using near-infrared fluorescence lymphatic imaging.

The change (from 3 months) in the area of the head and neck that is covered by abnormal dermal lymphatic backflow as assessed using near-infrared fluorescence lymphatic imaging.

The change (from 6 months) in the area of the head and neck that is covered by abnormal dermal lymphatic backflow as assessed using near-infrared fluorescence lymphatic imaging.

The University of Texas Health Science Center, Houston

Associate Professor

Fibrosis

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Complete Decongestive Therapy on Head and Neck Lymphedema	NCT04045860	Lymphedema of F... Secondary Lymph...	Complete Decong... Observation	18 Years -	Our Lady of the Lake Hospital
Assessing Impact of Early Physiotherapy on Lymphatic Dysfunction in Head and Neck Cancer Survivorship	NCT05937269	Lymphedema of F... Head and Neck C...	Near-infrared f... advanced pneuma...	18 Years -	The University of Texas Health Science Center, Houston
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

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