Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Blood and Lymph Conditions

Symptoms and General Pathology

Breast Neoplasms

Lymphedema

Breast Cancer Lymphedema

Breast Diseases

Skin Diseases

Lymphatic Diseases

Postoperative Complications

Group A will receive first PBM + manual lymphatic drainage for 9 weeks (2 sessions/week), followed by 9 weeks only manual lymphatic drainage.

Group B will first receive only manual lymphatic drainage for 9 weeks, followed by the combination of PBM and manual lymphatic drainage for 9 weeks (2x/week).

The MLS M6 laser from ASA will be used to apply the laser therapy.

Photobiomodulation therapy (PBMT)

Patients will receive twice weekly MLT executed by trained physiotherapist

Manual Lymphatic drainage

Jolien Robijns, PhD

Jeroen Mebis, MD, PhD

Joy Lodewijckx, MSc

Up to one out of five patients with breast cancer will develop lymphedema in the upper extremity after cancer treatment. Patients with breast cancer-related lymphedema (BCRL) suffer from pain, heaviness, tightness, and a decreased range of motion. Photobiomodulation therapy (PBMT) is a non-invasive therapy based on the application of visible and/or near-infrared light produced by a laser diode or a light-emitting diode. The scientifically proven biologic effects of PBM are improved wound healing, and a reduction in pain, inflammation, and oedema. Therefore, the aim of this study is to evaluate the effectiveness of PBMT on the management of BCRL.

This aim of this study is to determine the efficacy of PBMT in combination with the institutional therapy on the management of BCRL. Therefore, we hypothesize that PBMT in combination with manual lymphatic drainage is able to reduce the limb circumference and the associated pain and improve the QoL of patients with BCRL during treatment and up to 12 months post-treatment.

Primary Objective 1: Arm circumference

The study seeks primarily to determine the effectiveness PBMT and manual lymphatic drainage in reducing the arm circumference in patients with established BCRL during PBM treatment and up to 12 months post-PBMT.

Primary Objective 2: Activity and participation

Another primary aim of this study is to evaluate the effectiveness of PBMT and manual lymphatic drainage in the enhancement of the patients' activity and participation status.

Secondary Objective 1: Pain

A secondary aim of this study is to evaluate if PBMT and manual lymphatic drainage can reduce the BCRL-related pain during PBM treatment and up to 12 months post-PBMT.

Secondary Objective 2: Quality of life

A secondary aim of this study is to evaluate if PBMT and manual lymphatic drainage can improve the patients' QoL during PBM treatment and up to 12 months post-PBMT.

Secondary Objective 3: Depression

A secondary aim of this study is to evaluate if PBMT and manual lymphatic drainage can improve the patients' mental status during PBM treatment and up to 12 months post-PBMT.

Secondary Objective 4: Patient satisfaction

A secondary aim of this study is to evaluate if patients are satisfied with PBMT and manual lymphatic drainage as a treatment for BCRL during the treatment sessions and up to 12 months post-therapy.

Secondary Objective 5: PBM safety

A secondary aim of this study is to evaluate the safety of PBM in oncologic patients up to 5 years post-PBMT.

prospective randomized, controlled cross-over trial

Photobiomodulation Therapy for the Management of Breast Cancer-related Lymphedema

Evaluating the Effectiveness of Photobiomodulation Therapy in the Management of Breast Cancer-Related Lymphedema: a Randomized Controlled Trial

General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (e.g. age and smoking history). Information regarding the disease- and treatment-related risk factors will be collected through medical records (e.g., tumour type and stage).

The possible appearance and date of local and/or regional recurrence will be collected.

The possible appearance and date of secondary tumors will be collected.

The possible appearance and date of distant metastasis will be collected.

If the patient dies within the first year after the treatment, their date of death will be collected.

If the patient dies within 2 years after the treatment, their date of death will be collected.

If the patient dies within 3 years after the treatment, their date of death will be collected.

If the patient dies within 4 years after the treatment, their date of death will be collected.

If the patient dies within 5 years after the treatment, their date of death will be collected.

The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm.

The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 \* (C1\* C1 +C1\*C2+C2\*C2)/12π C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter

A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation.

The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities.

The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score can range from 0 (no disability) to 100 (most severe disability).

The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician.

The patients will be asked to evaluate their pain related to BCRL by using the Visual Analogue Scale (VAS). This scale ranges from 0 (no pain at all) to 10 (extreme agony).

The validated Lymphedema Functioning, Disability, and Health questionnaire for the upper limb (Lymph-ICF-UL) will be used to evaluate the patients' QoL. This scale ranges from 0 (no problem at all) to 100 (very severe problem).

The mental health of the patients will be determined using the Depression Anxiety Stress-Scale (DASS-21). Three different scores will be calculated: depression (0-21), anxiety (0-21) and stress (0-18). A lower score indicates a normal mental health, while a higher score indicates extremely severe depression, anxiety and/or stress.

The mental health of the patients will be determined using the Depression Anxiety Stress-Scale (DASS-21).

The patients will be asked to evaluate the general pleasantness and soothing effect of the therapeutic intervention and their global satisfaction with the therapeutic intervention, using the Numerical Rating Scale (NRS). This is scored on a scale from 0 (extremely dissatisfied) to 10 (extremely satisfied).

Hasselt University

Jessa Hospital

Nervous System Diseases

Peripheral Nervous System Diseases

During photobiomodulation therapy (PBMT) or low-level laser therapy, visible and/or (near)-infrared laser light is used at the affected area to improve tissue repair and thereby promote functional recovery of peripheral nerves

Multiwave Locked System® (M6 laser, ASA srl, Arcugnano (VI), Italy)

• The PBMT-group will receive twice-weekly laser sessions starting at first until the last week of chemotherapy (9-12 weeks depending on the type of chemotherapy)

photobiomodulation therapy (PBMT)

• The control group will undergo twice-weekly sham laser sessions starting at first until the last week of chemotherapy (9-12 weeks depending on the type of chemotherapy). The laser device will be placed on the same manner and for the same period of time on the identified body sites, but the device will not be switched on.

sham laser sessions

jeroen Mebis, prof. dr.

ne of the most common cancers in women worldwide is breast cancer. A common used therapy in early-stage and metastatic breast cancer involves chemotherapy. Taxanes, microtubule-targeting agents (MTAs), are one of the most used chemotherapeutic agents in breast cancer patients. Unfortunately, this treatment comes with many unfortunate side effects. Chemotherapy-induced peripheral neuropathy (CIPN) is one of these common side effects. This condition involves paresthesia, numbness and/or burning pain in distal limbs. Eventually, loss of temperature sensation, loss of tendon reflexes and pain sensation can occur. Yet, no therapies have been developed to treat CIPN. At the moment, only symptom management is possible. Not only will this condition affect the patients' daily activities, but a chemotherapy dose reduction could also be necessary, influencing the outcome and overall survival rate of the patient.

A new and emerging treatment for CIPN is photobiomodulation therapy (PBMT) or low-level laser therapy. During PBMT, visible and/or (near)-infrared laser light is used at the affected area to improve tissue repair and thereby promote functional recovery of peripheral nerves. Studies have shown positive results for patients with diabetic neuropathy. However, no studies have been undertaken specifically for taxane-induced neuropathy (TIN).

We hypothesize that PBMT is an effective treatment strategy to prevent sensory symptoms associated with TIN. This can lead to an improved quality of life for the patient and no need for a chemotherapy dose reduction.

PBMT for the Prevention of CIPN

The Use of Photobiomodulation Therapy for the Prevention of Chemotherapy-induced Peripheral Neuropathy: a Pilot Trial

he mTNS is a composite scale that includes patient report of sensory and motor symptoms, pin sensibility, quantitative vibration thresholds, strength using manual muscle tests, and deep tendon reflexes. The higher the score, the more severe the peripheral neuropathy. The mTNS is a clinically applicable, sensitive screening tool for CIPN.

The Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group Taxane scale (FACT/GOG-Taxane) is a patient questionnaire to test the quality of life of the patients with taxane induced neuropathy (TIN) and can be divided into five components: physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns specific for taxane treated patients. The higher the score, the better the quality of life.

mechanical visual analogue scale (VAS) will be used to evaluate the patients' pain level due to TIN.

prof. dr.

Substance Related Disorders

Immune System Diseases

Syndrome

Hand-Foot Syndrome

Exanthema

Drug Eruptions

Dermatitis

Hypersensitivity

Drug Hypersensitivity

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

The experimental group receives 9 sessions of photobiomodulation therapy (3x/week for 3 weeks).

Patients will receive PBM on the sole of their feet and palms of their hands

Hand-foot syndrome (HFS) is a side effect of chemotherapy. HFS is characterized by redness, swelling, and pain on the palms of the hands and/or soles of the feet, which can progress to blistering. Hand-foot skin reaction (HFSR) refers to symptoms affecting the hands and/or feet associated with multikinase inhibitors (TKIs). HFS and HFSR are painful complications that can lead to compromised daily activities, sleep-wake disturbance and impaired mobility, eventually decreasing Quality of Life (QoL).

Photobiomodulation therapy (PBMT) is a non-invasive therapy based on the application of visible and/or near-infrared light produced by a laser diode or a light-emitting diode. The scientifically proven biologic effects of PBM are improved wound healing, and a reduction in pain, inflammation, and oedema. The aim of this study is to evaluate the effectiveness of PBMT in the management of HFS and HFSR.

The aim of this study is to evaluate the efficacy of PBMT in the management of HFS and HFSR in patients with cancer treated with chemotherapy or TKIs up to 2 weeks post-PBMT.

Primary objective: The study seeks primarily to determine the effectiveness of PBMT in reducing the severity of HFS and HFSR in patients with cancer of different etiology undergoing chemotherapy or TKIs, diagnosed with HFS or HFSR (grade 1-3).

Secondary objective 1 : HFS/HFSR-related symptoms

A secondary aim of this study is to evaluate if PBMT and can reduce the HFS/HSFR-related symptoms during PBM treatment and up to 2 weeks post-PBMT

Secondary Objective 2: Quality of life

A secondary aim of this study is to evaluate if PBMT can improve the patients' QoL during PBM treatment and up to 2 weeks post-PBMT

Secondary Objective 3: Patient satisfaction

A secondary aim of this study is to evaluate if patients are satisfied with PBMT as a treatment for HFS and HFSR during the treatment sessions and up to 2 weeks post-PBMT

Secondary Objective 4: PBM safety

A secondary aim of this study is to evaluate the safety of PBM in oncologic patients up to 5 years post-PBMT.

Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction

Evaluating the Effectiveness of Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction: A Single-arm Trial

General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (i.e., gender, age, smoking history, work habits, physical activity, skin condition, alcohol use, and medication use). Furthermore, information about disease- and treatment-related risk factors will be collected through medical records (e.g., tumor type and stage, tumor site, treatment type, etc).

The severity of the skin reactions will be evaluated by the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5.

The severity of the skin reactions will be evaluated by the World Health Association (WHO) grading scale for HFS/HFSR

A clinical photograph of the palm of patients' hands and sole of their feet

The patients will be asked to complete a questionnaire to evaluate the intensity of eight common symptoms of HFS/HFSR: pruritus, dryness, erythema, burning sensation, oedema, desquamation, blistering, and pain on an 11-point Numerical Rating Scale (NRS)

Dermatology Life Quality Index (DLQI) is a questionnaire with 10 items and is used to measure QoL of dermatological patients.

The skindex-29 is a validated instrument to measures patients' QoL specifically correlated with skin conditions. It has 3 scales addressing emotions (10 items), symptoms (7 items) and functioning (12 items).

The patients will be asked to evaluate their satisfaction with PBM on a 5-point Likert scale

Wounds and Injuries

Rare Diseases

Radiation Injuries

Radiodermatitis

Acute Graft Versus Host Disease

Receives sham laser (2x/week) in combination with standard skin care starting from day 1 of radiotherapy

Receives PBMT (2x/week) in combination with standard skin care starting from day 1 of radiotherapy

PBMT sessions will be planned 2x/week after RT.

Sham laser sessions will be applied 2x/week after RT.

Sham laser

Radiodermatitis (RD), an inflammatory skin reaction, occurs in more than 90 percent of cancer patients treated with radiotherapy (RT). This is the result of the radiation causing damage to the epidermal basal skin stem cells. Based on the severity of the skin symptoms, acute RD can be categorized into four grades ranging from red and dry skin to moist desquamation, necrosis, and eventually ulceration. Acute RD can be distressing, negatively influencing the patients' quality of life (QOL). In cases of severe RD, RT might be interrupted, affecting the treatment outcome.

Currently, there is no generally accepted treatment available for RD. As such, the standard skincare treatment is hospital dependent. Photobiomodulation therapy (PBMT) can offer a solution, since the therapeutic use of (infra)red light induces photochemical reactions in the target cells, stimulating repair and healing processes, and reducing pain and inflammation.

Previous studies using PBMT to prevent RD showed promising results. However, these beneficial results need to be validated in a larger breast cancer patient population receiving an alternative RT regimen. The study hypothesizes that PBMT is a safe and effective strategy to prevent worsening of acute RD grade two or higher in breast cancer patients undergoing RT. The primary objective is to measure the degree of acute RD to detect changes during and after RT. Second, the patients' QOL and pain will be assessed. Finally, the third objective is to evaluate the safety of PBMT.

The results of this project will support the implementation of PBMT into the standard RD skincare program.

Photobiomodulation Therapy for the Prevention of Acute Radiodermatitis in Breast Cancer Patients Undergoing Radiotherapy

The Use of Photobiomodulation Therapy for the Prevention of Acute Radiodermatitis in Breast Cancer Patients: a Multicentre, Randomized, Placebo-controlled Trial

Objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC) objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC)

Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)

Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS 0-4)

Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS 0- 4)

Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS (0 - 4)

Patients' pain due to radiodermatitis will be evaluated using the visual analogue scale (VAS 0-10). A VAS is a laminated plastic with descriptors at each end. The patients will be asked to move the sliding marker along the plastic to indicate their subjective experience of pain. Each mark is associated with a certain pain score. A VAS is a well documented, valid, and frequently used measure of pain intensity.

The Skindex-16 questionnaire will be used to assess patients quality of life. This is the most appropriate questionnaire that accurately and sensitively measures to what extent the patients' life is affected by their skin condition.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Photobiomodulation Therapy for the Management of Breast Cancer-related Lymphedema	NCT04690439	Breast Cancer Breast Cancer R... Lymphedema of U...	Photobiomodulat... Manual Lymphati...	18 Years -	Jessa Hospital
Photobiomodulation Therapy for the Management of Breast Cancer-related Lymphedema	NCT04690439	Breast Cancer Breast Cancer R... Lymphedema of U...	Photobiomodulat... Manual Lymphati...	18 Years -	Jessa Hospital
PBMT for the Prevention of CIPN	NCT03391271	Breast Cancer	photobiomodulat... sham laser sess...	18 Years -	Hasselt University
Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction	NCT04979078	Hand-foot Syndr... Hand-foot Skin ...	Photobiomodulat...	18 Years -	Jessa Hospital
Photobiomodulation Therapy for the Prevention of Acute Radiodermatitis in Breast Cancer Patients Undergoing Radiotherapy	NCT03924011	Radiodermatitis Breast Cancer	Photobiomodulat... Sham laser	18 Years -	Hasselt University

Spots Global Cancer Trial Database for photobiomodulation therapy (pbmt)