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

Not Applicable

Completed

• Conditions: Breast Cancer; Radiodermatitis
• Interventions: Device: Sham laser; Device: Photobiomodulation therapy (PBMT)

• Registration Number: NCT03924011
• Lead Sponsor: Hasselt University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-04-22
• Study First Posted: 2019-04-23
• Study Start: 2020-07-01
• Primary Completion: 2021-03-01
• Study Completion: 2021-06-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 71

Inclusion Criteria

• Informed Consent as documented by signature
• 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 at Ziekenhuis Oost-Limburg, Genk:
• Hypofractionated radiotherapy regimen (i.e. 16 daily fractions of 2.66 Gray to the whole breast followed by a boost of 5 fractions of 2.66 Gray to the tumor bed, 5x/week)

Exclusion Criteria

• Scheduled for postoperative radiotherapy at Jessa Hospital, Hasselt, Belgium
• 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 to ensure an optimal distribution of the radiation dose; mostly used for treatment of superficial tumors)
• Known or suspected non-compliance, drug or alcohol abuse
• Inability to follow the procedures of the study, e.g. due to language problems, psyschological disorders, dementia, etc. of the participant
• Seizure
• Disorders triggered by lighttake anticoagulants
• Hemorrhagic diatheses
• Pregnancy
• Suspected of carrying serious infectious disease
• HIV positive history

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Sham laser	Receives sham laser (2x/week) in combination with standard skin care starting from day 1 of radiotherapy
Treatment group	Photobiomodulation therapy (PBMT)	Receives PBMT (2x/week) in combination with standard skin care starting from day 1 of radiotherapy

Primary Outcome Measures

Name	Time	Method
Radiation Dermatitis Assessment	week 6	Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS (0 - 4)
Radiation Dermatitis Grade	week 6	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)

Secondary Outcome Measures

Name	Time	Method
Quality of life assessment	week 6	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.
Pain evaluation: VAS	week 6	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.

Trial Locations

Locations (2)

Ziekenhuis Oost-Limburg Campus St.-Jan; 🇧🇪 Genk, Limburg, Belgium

Jessa Ziekenhuis; 🇧🇪 Hasselt, Belgium