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

NCT03924011 | Completed

• 1 other identifier: Labra-001
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 2

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

Keywords

Radiodermatitis; Breast cancer; Radiotherapy; Photobiomodulation therapy; Low-level light therapy; Skin diseases; Radiation injuries; Wounds and injuries; Oncology

Outcome Measures

Primary Outcomes (12)

• 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) 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)

  week 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) 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)

  week 2

• 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) 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)

  week 3

• 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) 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)

  week 4

• 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) 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)

  week 5

• 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) 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)

  week 6

• Radiation Dermatitis Assessment

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

  week 1

• Radiation Dermatitis Assessment

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

  week 2

• Radiation Dermatitis Assessment

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

  week 3

• Radiation Dermatitis Assessment

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

  week 4

• Radiation Dermatitis Assessment

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

  week 5

• Radiation Dermatitis Assessment

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

  week 6

Secondary Outcomes (12)

• Pain evaluation: VAS

  week 1

• Pain evaluation: VAS

  week 2

• Pain evaluation: VAS

  week 3

• Pain evaluation: VAS

  week 4

• Pain evaluation: VAS

  week 5

Study Arms (2)

Control group

SHAM COMPARATOR

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

Device: Sham laser

Treatment group

EXPERIMENTAL

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

Device: Photobiomodulation therapy (PBMT)

Interventions

Photobiomodulation therapy (PBMT) DEVICE

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

Also known as: Low-level light therapy (LLLT)

Treatment group

Sham laser DEVICE

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasselt University: lead
• Jessa Hospital: collaborator
• Ziekenhuis Oost-Limburg: collaborator

Study Sites (2)

Ziekenhuis Oost-Limburg Campus St.-Jan

Genk, Limburg, 3600, Belgium

Location

Jessa Ziekenhuis

Hasselt, 3500, Belgium

Location

MeSH Terms

Conditions

Radiodermatitis; Breast Neoplasms; Skin Diseases; Radiation Injuries; Wounds and Injuries; Neoplasms

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Dermatitis; Skin and Connective Tissue Diseases; Neoplasms by Site; Breast Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Jolien Robijns, PhD

  Hasselt University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: April 23, 2019
• Study Start: July 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: June 1, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-08

Locations

BE (2)