Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Wounds and Injuries

Breast Neoplasms

Radiodermatitis

Breast Diseases

Skin Diseases

Dermatitis

Radiation Injuries

Treatment group (receives low-level laser therapy (2x/week) in combination with standard skin care starting from day 1 of radiotherapy)

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

Low-Level Laser Therapy will be applied, twice a week, from the start of radiotherapy treatment (14 sessions in total) in combination with the standard skin care.

Low-level laser

Sham Laser Therapy will be applied, twice a week, from the start of radiotherapy treatment (14 sessions in total) in combination with the standard skin care.

sham laser

radiotherapy

Jeroen Mebis, prof. dr.

Up to 90% of the radiotherapy patients will develop a certain degree of skin reaction at the treated area, also known as radiodermatitis (RD).

Currently, there is a wide variety of strategies to manage RD, including creams, gels, ointments, wound dressings. However, up to now, there is still no comprehensive, evidence-based consensus for the treatment of RD. Low-level laser therapy (LLLT) is a promising, non-invasive technique for treating RD. In a recent pilot study conducted in our research group, LLLT prevented the aggravation of RD and provided symptomatic relief in patients undergoing radiotherapy for breast cancer after breast-sparing surgery. This pilot study was the first prospective study investigating the potential of LLLT for RD. In the current study, we want to investigate the efficacy of LLLT as a tool for the prevention of radiodermatitis in breast cancer patients.

Laser Therapy for the Prevention of Radiodermatitis in Breast Cancer Patients

Low-level Laser Therapy as a Tool for the Prevention of Radiodermatitis in Breast Cancer Patients

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)

Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin

Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration

Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin

Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA

Evaluation of pain using a Visual Analogue Scale (VAS)

Health-related quality of life measure specific to skin diseases

Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis

3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation

Jessa Hospital

Hasselt University

prof. dr.

Head and Neck Neoplasms

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

Treatment Group: receives low-level laser therapy (2x/week) in combination with standard skin care starting from day 1 of radiotherapy

Low-Level Laser Therapy will be applied, twice a week, from the start of radiotherapy treatment in combination with the standard skin care.

Low-level laser therapy

Up to 90% of the radiotherapy patients will develop a certain degree of skin reaction at the treated area, also known as radiodermatitis (RD).

Currently, there is a wide variety of strategies to manage RD, including creams, gels, ointments, wound dressings. However, up to now, there is still no comprehensive, evidence-based consensus for the treatment of RD. Low-level laser therapy (LLLT) is a promising, non-invasive technique for treating RD. In a recent study conducted in our research group, LLLT prevented the aggravation of RD and provided symptomatic relief in patients undergoing radiotherapy for breast cancer after breast-sparing surgery. This was the first prospective study investigating the potential of LLLT for RD. In the current study, we want to investigate the efficacy of LLLT as a tool for the prevention of radiodermatitis in head and neck cancer patients.

Laser Therapy for the Prevention of Radiodermatitis in Head and Neck Patients

Low-level Laser Therapy as a Tool for the Prevention of Radiodermatitis in Head and Neck Cancer Patients

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)

Tewameter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin

Corneometer CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration

Mexameter MX18 will be used to objectively measure the degree of erythema of the skin

Evaluation of pain using a visual analogue scale (VAS)

Health-related quality of life measure specific to skin diseases (Skindex-16)

Rare Diseases

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.

Photobiomodulation therapy (PBMT)

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

Sham laser

Jolien Robijns, PhD

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
Laser Therapy for the Prevention of Radiodermatitis in Breast Cancer Patients	NCT02443493	Breast Cancer	Low-level laser sham laser radiotherapy	-	Hasselt University
Laser Therapy for the Prevention of Radiodermatitis in Head and Neck Patients	NCT02738268	Head Cancer Neck Cancer	Low-level laser... sham laser	-	Hasselt University
Laser Therapy for the Prevention of Radiodermatitis in Breast Cancer Patients	NCT02443493	Breast Cancer	Low-level laser sham laser radiotherapy	-	Hasselt University
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 sham laser

Every month we try and update this database with for sham laser cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sham laser

Every month we try and update this database with for sham laser cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sham laser cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.