Polarized Light Therapy for Radiation Dermatitis in Breast Cancer (PLARD-BREAST)
Efficacy of Polarized Polychromatic Light Therapy on Acute Radiation Dermatitis in Breast Cancer Patients: A Randomized Controlled Trial
연구 개요
상태
상세 설명
Acute radiation dermatitis is one of the most frequent adverse effects associated with breast cancer radiotherapy and may negatively affect patient comfort, treatment adherence, and quality of life. Clinical manifestations range from mild erythema and dry desquamation to severe moist desquamation and ulceration. Although standard skin care measures are routinely implemented, effective preventive and therapeutic non-invasive interventions remain limited.
Polarized polychromatic non-coherent light therapy has demonstrated anti-inflammatory, microcirculatory, tissue regenerative, and wound-healing effects in several dermatologic and musculoskeletal conditions. However, evidence regarding its efficacy for radiation-induced skin toxicity remains insufficient.
This prospective randomized assessor-blinded controlled trial will investigate the effectiveness of polarized light therapy as an adjunctive supportive treatment for acute radiation dermatitis in women receiving hypo fractionated whole-breast irradiation (40-42.5 Gy in 15-16 fractions over approximately 3 weeks) following breast-lumpectomy for breast cancer.
Participants will be randomly assigned into two parallel groups:
- Polarized light therapy plus Standard skin care.
- Standard skin care alone. The polarized light intervention will be initiated on the first day of radiotherapy and administered three times weekly throughout the radiotherapy course using the Bioptron Light Therapy System.
The primary outcome will be ultrasound-based dermal thickness changes within the irradiated breast region. Secondary outcomes will include clinical severity of radiation dermatitis using Radiation Therapy Oncology Group (RTOG) criteria Assessments will be conducted at baseline, Week 2, Week 4, Week 6, Week 8, and at 2-month follow-up. The study aims to determine whether polarized light therapy can reduce radiation-induced skin inflammation, delay progression of dermatitis severity, improve symptom burden, and enhance skin recovery compared with standard care alone.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Marwa Elsayed Mohamed Lecturer, Ph.D
- 전화번호: 01141825442
- 이메일: Marwa.elsayed@pt.bsu.edu.eg
연구 장소
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Banī Suwayf, 이집트
- 모병
- Out patient clinic , faculty of Physical Therapy, Beni Sueif university
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연락하다:
- Marwa Elsayed Mohamed Lecturer, Ph.D
- 전화번호: 01141825442
- 이메일: Marwa.elsayed@pt.bsu.edu.eg
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Female patients aged 35-55 years.
- Histologically confirmed primary unilateral breast cancer.
- Status post breast-conserving surgery (lumpectomy).
- Planned for hypo fractionated whole-breast irradiation (HFWBI).
- Scheduled to receive a total radiation dose of 40-42.5 Gy delivered in 15-16 fractions over approximately 3 weeks.
- Ability to understand study procedures and provide written informed consent.
Exclusion Criteria:
- Previous radiotherapy to the same breast or thoracic region.
- Bilateral breast cancer.
- Metastatic or advanced systemic disease.
- Prior mastectomy.
- Active skin infection in the irradiated area.
- Pre-existing dermatologic disorders affecting the breast skin (e.g., eczema, psoriasis, dermatitis).
- Concurrent chemotherapy during radiotherapy.
- Presence of cardiac pacemaker or implantable electronic device in the treatment field.
- Open wounds or ulceration in the irradiated breast region.
- Any medical condition judged by the investigator to interfere with study participation or outcome assessment.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Polarized Light Therapy + Standard Care
Participants will receive polarized polychromatic non-coherent light therapy combined with routine institutional skin care management during the radiotherapy course.
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Polarized polychromatic non-coherent light therapy will be administered using the Bioptron Light Therapy System.
The device emits light with a wavelength spectrum ranging from 480-3400 nm, polarization >95%, and irradiance approximately 40 mW/cm².
Treatment will be applied perpendicular to the irradiated breast skin surface from a distance of approximately 10 cm for 6-10 minutes per treatment field, corresponding to an estimated fluence of approximately 2.4 J/cm² per minute.
Sessions will be administered three times weekly on alternating days beginning from the first radiotherapy session and continuing throughout the radiotherapy course.
The entire irradiated breast field will be treated.
Routine institutional radiation skin care protocol including conventional skin care initiated from the first day of radiotherapy, with application of hydroactive colloid gel for three days as needed.
An absorbent foam self-adhesive silicone dressing will be used in cases of painful skin reactions or moist desquamation.
Participants will also receive standardized skin care instructions including gentle washing with mild soap or water only, patting the skin dry with a soft absorbent towel rather than rubbing, maintenance of skin hydration, and avoidance of friction, tight clothing, perfumes, and other potential skin irritants throughout the radiotherapy course.
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다른: Standard Care Alone
Participants will receive standard institutional skin care management during radiotherapy.
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Routine institutional radiation skin care protocol including conventional skin care initiated from the first day of radiotherapy, with application of hydroactive colloid gel for three days as needed.
An absorbent foam self-adhesive silicone dressing will be used in cases of painful skin reactions or moist desquamation.
Participants will also receive standardized skin care instructions including gentle washing with mild soap or water only, patting the skin dry with a soft absorbent towel rather than rubbing, maintenance of skin hydration, and avoidance of friction, tight clothing, perfumes, and other potential skin irritants throughout the radiotherapy course.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Ultrasound Skin Thickness
기간: Baseline, Week 2, Week 4, Week 6, Week 8, and 2-month follow-up.
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Objective assessment of radiation-induced skin structural changes using high-frequency musculoskeletal ultrasound imaging of the irradiated breast region.
Dermal thickness measurements (mm) will be performed by the same radiologist for both groups throughout the study.
A standardized layer of ultrasound gel approximately 1 mm thick will be used as a coupling medium to optimize image acquisition.
Measurements will be obtained from the most clinically affected area within the irradiated breast field.
To improve accuracy and reliability, the average of three consecutive measurements will be recorded for analysis.
Special care will be taken to avoid compression artifacts by gently applying the ultrasound probe to the skin surface with minimal pressure.
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Baseline, Week 2, Week 4, Week 6, Week 8, and 2-month follow-up.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Radiation Therapy Oncology Group (RTOG) Severity
기간: Baseline, Week 2, Week 4, Week 6, Week 8, and 2-month follow-up.
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Clinical severity of acute radiation dermatitis will be assessed using the Radiation Therapy Oncology Group (RTOG) acute radiation morbidity scoring criteria.
Skin reactions within the irradiated breast area will be evaluated and classified according to the degree of skin irritation and tissue damage as follows: RTOG Grade 0: no visible skin change; Grade 1: mild erythema, epilation, sweating, or dry desquamation; Grade 2: bright or painful erythema, patchy moist desquamation, or moderate edema; Grade 3: confluent moist desquamation extending beyond skin folds and pitting edema; Grade 4: ulceration, necrosis, or bleeding.
Assessments will be conducted by a blinded assessor under standardized clinical conditions throughout the study period.
Scoring criteria ranging from Grade 0 to Grade 4.
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Baseline, Week 2, Week 4, Week 6, Week 8, and 2-month follow-up.
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- Polarized light Dermatitis 26
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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