Actively Recruiting
Efficacy of Polarized Polychromatic Light Therapy to Reduce Acute Radiation Dermatitis in Women Undergoing Hypofractionated Whole-Breast Radiotherapy for Breast Cancer
Led by Beni-Suef University · Updated on 2026-05-26
60
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of polarized polychromatic non-coherent light therapy as an addition to standard skin care in reducing acute radiation dermatitis among women with breast cancer undergoing hypofractionated whole-breast radiotherapy. Acute radiation dermatitis, a common side effect of breast cancer radiotherapy, can range from mild redness to severe skin damage and may reduce patient comfort and treatment adherence. The study will compare standard skin care alone to combined treatment with polarized light therapy to assess if the light therapy can improve skin outcomes. Participants will be randomly assigned to one of two groups: one receiving standard skin care plus polarized light therapy, and the other receiving standard skin care alone. The light therapy will be delivered using the Bioptron Light Therapy System, applied three times weekly from the first day of radiotherapy through the course of treatment, which lasts about three weeks with 15-16 fractions totaling 40-42.5 Gy. Standard skin care involves gentle washing, hydration, and protective measures against skin irritation. Participants will undergo evaluations including ultrasound measurements of skin thickness and clinical assessment of radiation dermatitis severity using Radiation Therapy Oncology Group (RTOG) criteria at baseline, during treatment at weeks 2, 4, 6, and 8, and at a 2-month follow-up. The study will monitor changes in skin inflammation and healing, aiming to determine if polarized light therapy can delay progression and improve skin recovery. The total participation spans the radiotherapy course plus follow-up assessments extending to about 10 weeks.
CONDITIONS
Brief Title
Polarized Light Therapy for Radiation Dermatitis in Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 35-55 years
- Histologically confirmed primary unilateral breast cancer
- Status post breast-conserving surgery (lumpectomy)
- Planned for hypofractionated whole-breast irradiation
- Scheduled to receive a total radiation dose of 40-42.5 Gy in 15-16 fractions over about 3 weeks
- Ability to understand study procedures and provide written informed consent
You will not qualify if you...
- 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 such as eczema, psoriasis, or 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
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 weeks
Participants receive either polarized polychromatic light therapy combined with standard skin care or standard skin care alone during their radiotherapy course.
Three visits per week (in-person) for light therapy sessions plus routine radiotherapy visits
Duration - Up to 2 months after treatment ends
Participants are assessed for skin changes and radiation dermatitis severity after completing radiotherapy to monitor recovery and treatment effects.
Visits at Week 4, Week 6, Week 8, and 2-month follow-up
Trial Site Locations
Total: 1 location
1
Out patient clinic , faculty of Physical Therapy, Beni Sueif university
Banī Suwayf, Egypt
Actively Recruiting
Research Team
M
Marwa Elsayed Mohamed Lecturer, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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