Clinical trial NCT03924011: Photobiomodulation Therapy for the Prevention of Acute Radiodermatitis in Breast Cancer Patients Undergoing Radiotherapy
Official title: The Use of Photobiomodulation Therapy for the Prevention of Acute Radiodermatitis in Breast Cancer Patients: a Multicentre, Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiodermatitis
Breast Cancer
Keywords: Radiodermatitis
Breast cancer
Radiotherapy
Photobiomodulation therapy
Low-level light therapy
Skin diseases
Radiation injuries
Wounds and injuries
Oncology
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
name: Ziekenhuis Oost-Limburg
First posted: 2019-04-23
Enrollment: 71
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Radiation Dermatitis Grade
timeFrame: week 1
measure: Radiation Dermatitis Grade
timeFrame: week 2
measure: Radiation Dermatitis Grade
timeFrame: week 3
measure: Radiation Dermatitis Grade
timeFrame: week 4
measure: Radiation Dermatitis Grade
timeFrame: week 5
measure: Radiation Dermatitis Grade
timeFrame: week 6
measure: Radiation Dermatitis Assessment
timeFrame: week 1
measure: Radiation Dermatitis Assessment
timeFrame: week 2
measure: Radiation Dermatitis Assessment
timeFrame: week 3
measure: Radiation Dermatitis Assessment
timeFrame: week 4
measure: Radiation Dermatitis Assessment
timeFrame: week 5
measure: Radiation Dermatitis Assessment
timeFrame: week 6
Secondary outcomes:
measure: Pain evaluation: VAS
timeFrame: week 1
measure: Pain evaluation: VAS
timeFrame: week 2
measure: Pain evaluation: VAS
timeFrame: week 3
measure: Pain evaluation: VAS
timeFrame: week 4
measure: Pain evaluation: VAS
timeFrame: week 5
measure: Pain evaluation: VAS
timeFrame: week 6
measure: Quality of life assessment
timeFrame: week 1
measure: Quality of life assessment
timeFrame: week 2
measure: Quality of life assessment
timeFrame: week 3
measure: Quality of life assessment
timeFrame: week 4
measure: Quality of life assessment
timeFrame: week 5
measure: Quality of life assessment
timeFrame: week 6
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg Campus St.-Jan
state: Limburg
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
Study officials:
affiliation: Hasselt University
name: Jolien Robijns, PhD
role: STUDY_DIRECTOR
References: