Laser Therapy for the Prevention of Radiodermatitis in Breast Cancer Patients (TRANSDERMIS)

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Radiation: radiotherapy; Device: Low-level laser; Device: sham laser

• Study Type: Interventional
• Enrollment (Actual): 139
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Hasselt, Belgium, 3500
    • Jessa Hospital - Oncology department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Diagnosis of non-invasive (stage 0) or invasive (stage 1, 2 and 3A) breast adenocarcinoma
• Treatment with primary breast-sparing surgery (lumpectomy) and/or neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy or hormonal therapy
• Scheduled for postoperative radiotherapy with standard technique (isocentric) and fractionation regime (i.e. 25 daily fractions of 2 Gray to the whole breast followed by a boost of 8 fractions of 2 Gray to the tumor bed, 5/week)
• Signed informed consent

Exclusion Criteria:

• Previous irradiation to the same breast
• Metastatic disease
• Concurrent chemotherapy
• Required use of bolus material to deliver radiotherapy (i.e. material placed on the to- be-irradiated zone to modulate the delivered dose in order the ensure an optimal distribution of the radiation dose; mostly used for treatment of superficial tumors)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Treatment group (receives low-level laser therapy (2x/week) in combination with standard skin care starting from day 1 of radiotherapy)	Radiation: radiotherapy; Device: Low-level laser; 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.; Other Names: LLLT
Sham Comparator: Control group; Control group (receives sham laser (2x/week) in combination with standard skin care starting from day 1 of radiotherapy)	Radiation: radiotherapy; Device: sham 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation Dermatitis Grade	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)	day 1
Radiation Dermatitis Grade	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)	day 20
Radiation Dermatitis Grade	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)	day 33
Radiation Dermatitis Grade	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)	day 40
Radiation Dermatitis Grade	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)	day 54
Radiation Dermatitis Assessment	radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)	day 1
Radiation Dermatitis Assessment	radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)	day 20
Radiation Dermatitis Assessment	radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)	day 33
Radiation Dermatitis Assessment	radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)	day 40
Radiation Dermatitis Assessment	radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)	day 54
Objective measurement of trans epidermal water loss of the skin	Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin	day 1
Objective measurement of trans epidermal water loss of the skin	Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin	day 20
Objective measurement of trans epidermal water loss of the skin	Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin	day 33
Objective measurement of trans epidermal water loss of the skin	Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin	day 40
Objective measurement of trans epidermal water loss of the skin	Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin	day 54
Objective measurement of the skin hydration	Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration	day 1
Objective measurement of the skin hydration	Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration	day 20
Objective measurement of the skin hydration	Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration	day 33
Objective measurement of the skin hydration	Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration	day 40
Objective measurement of 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	day 54
Objective measurement of degree of erythema of the skin	Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin	day 1
Objective measurement of degree of erythema of the skin	Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin	day 20
Objective measurement of degree of erythema of the skin	Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin	day 33
Objective measurement of degree of erythema of the skin	Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin	day 40
Objective measurement of degree of erythema of the skin	Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin	day 54
Analyze the skin cytokine content of the irradiated and non-irradiated breast	Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA	day 1
Analyze the skin cytokine content of the irradiated and non-irradiated breast	Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA	day 20
Analyze the skin cytokine content of the irradiated and non-irradiated breast	Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA	day 33
Analyze the skin cytokine content of the irradiated and non-irradiated breast	Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA	day 40
Analyze the skin cytokine content of the irradiated and non-irradiated breast	Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA	day 54

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Evaluation of pain using a Visual Analogue Scale (VAS)	day 1
Pain	Evaluation of pain using a Visual Analogue Scale (VAS)	day 20
Pain	Evaluation of pain using a Visual Analogue Scale (VAS)	day 33
Pain	Evaluation of pain using a Visual Analogue Scale (VAS)	day 40
Pain	Evaluation of pain using a Visual Analogue Scale (VAS)	day 54
Quality of life	Health-related quality of life measure specific to skin diseases	day 1
Quality of life	Health-related quality of life measure specific to skin diseases	day 20
Quality of life	Health-related quality of life measure specific to skin diseases	day 33
Quality of life	Health-related quality of life measure specific to skin diseases	day 40
Quality of life	Health-related quality of life measure specific to skin diseases	day 54
Satisfaction with therapy	Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis	day 1
Satisfaction with therapy	Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis	day 20
Satisfaction with therapy	Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis	day 33
Satisfaction with therapy	Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis	day 40
Satisfaction with therapy	Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis	day 54
moist desquamation	3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation	day 1
moist desquamation	3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation	day 20
moist desquamation	3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation	day 33
moist desquamation	3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation	day 40
moist desquamation	3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation	day 54

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: Jessa Hospital
• Investigators: Principal Investigator: Jeroen Mebis, prof. dr., Universiteit Hasselt/ Jessa ziekenhuis

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: May 11, 2015
• First Submitted That Met QC Criteria: May 12, 2015
• First Posted (Estimate): May 13, 2015

Study Record Updates

• Last Update Posted (Actual): July 26, 2019
• Last Update Submitted That Met QC Criteria: July 25, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Wounds and Injuries; Breast Diseases; Dermatitis; Radiation Injuries; Breast Neoplasms; Radiodermatitis
• Other Study ID Numbers: 15.38/onco15.06