Polarized Light Therapy for Radiation Dermatitis in Breast Cancer
Recruiting · NCT07600957 · Interventional (participants receive a specific treatment) · Lead sponsor: Beni-Suef University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- Out patient clinic , faculty of Physical Therapy, Beni Sueif university - Banī Suwayf, Egypt