Polarized Light Therapy for Radiation Dermatitis in Breast Cancer

Официальное название

Efficacy of Polarized Polychromatic Light Therapy on Acute Radiation Dermatitis in Breast Cancer Patients: A Randomized Controlled Trial

Обзор

This assessor-blinded randomized controlled trial aims to evaluate the efficacy of polarized polychromatic non-coherent light therapy as an adjunct to standard skin care in reducing acute radiation dermatitis in women with breast cancer undergoing hypofractionated whole-breast radiotherapy. Participants will be randomly allocated to receive either standard skin care alone or standard care combined with polarized light therapy initiated from the first radiotherapy session. Outcomes will include objective ultrasound-based dermal thickness measurements, clinical severity of radiation dermatitis using Radiation Therapy Oncology Group (RTOG) criteria.

Подробное описание

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:

1. Polarized light therapy plus Standard skin care. 2. 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.

Вмешательства

• Устройство Polarized Polychromatic Light Therapy
  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 ad
• Другое Standard Skin Care
  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 t

Первичные конечные точки

• Ultrasound Skin Thickness [Срок оценки: Baseline, Week 2, Week 4, Week 6, Week 8, and 2-month follow-up.]

Вторичные конечные точки (1)

• Radiation Therapy Oncology Group (RTOG) Severity [Срок оценки: Baseline, Week 2, Week 4, Week 6, Week 8, and 2-month follow-up.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Out patient clinic , faculty of Physical Therapy, Beni Sueif university — Banī Suwayf

Идентификаторы

NCT: NCT07600957 · Polarized light Dermatitis 26

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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