RecruitingNot ApplicableNCT07600957

Polarized Light Therapy for Radiation Dermatitis in Breast Cancer

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

Sponsor

Beni-Suef University

Enrollment

60 participants

Start Date

May 21, 2026

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Survivors Radio Dermatitis Polarized Light

Summary

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.

Eligibility

Sex: FEMALEMin Age: 35 YearsMax Age: 55 Years

Inclusion Criteria6

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 Criteria10

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.

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Interventions

DEVICEPolarized 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 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.

OTHERStandard 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 than rubbing, maintenance of skin hydration, and avoidance of friction, tight clothing, perfumes, and other potential skin irritants throughout the radiotherapy course.