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

NCT ID: NCT03924011

Last Updated: 2021-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2021-06-01

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.

Conditions

Radiodermatitis; Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control group

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

Group Type: SHAM_COMPARATOR

Sham laser

Intervention Type: DEVICE

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

Treatment group

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

Group Type: EXPERIMENTAL

Photobiomodulation therapy (PBMT)

Intervention Type: DEVICE

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

Interventions

Photobiomodulation therapy (PBMT)

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

Intervention Type: DEVICE

Sham laser

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

Intervention Type: DEVICE

Other Intervention Names

Low-level light therapy (LLLT)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jessa Hospital

OTHER

Sponsor Role: collaborator

Ziekenhuis Oost-Limburg

OTHER

Sponsor Role: collaborator

Hasselt University

OTHER

Sponsor Role: lead

Responsible Party

Prof. dr. Jeroen Mebis

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jolien Robijns, PhD

Role: STUDY_DIRECTOR

Hasselt University

Locations

Ziekenhuis Oost-Limburg Campus St.-Jan

Genk, Limburg, Belgium

Jessa Ziekenhuis

Hasselt, , Belgium

Countries

Belgium

Other Identifiers

Labra-001

Identifier Type: -

Identifier Source: org_study_id