NCT07600957 Polarized Light Therapy for Radiation Dermatitis in Breast Cancer
| NCT ID | NCT07600957 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beni-Suef University |
| Condition | Radio Dermatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-05-21 |
| Primary Completion | 2027-01-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-05-21 with a primary completion date of 2027-01-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Female patients aged 35-55 years. 2. Histologically confirmed primary unilateral breast cancer. 3. Status post breast-conserving surgery (lumpectomy). 4. Planned for hypo fractionated whole-breast irradiation (HFWBI). 5. Scheduled to receive a total radiation dose of 40-42.5 Gy delivered in 15-16 fractions over approximately 3 weeks. 6. Ability to understand study procedures and provide written informed consent. Exclusion Criteria: 1. Previous radiotherapy to the same breast or thoracic region. 2. Bilateral breast cancer. 3. Metastatic or advanced systemic disease. 4. Prior mastectomy. 5. Active skin infection in the irradiated area. 6. Pre-existing dermatologic disorders affecting the breast skin (e.g., eczema, psoriasis, dermatitis). 7. Concurrent chemotherapy during radiotherapy. 8. Presence of cardiac pacemaker or implantable electronic device in the treatment field. 9. Open wounds or ulceration in the irradiated breast region. 10. Any medical condition judged by the investigator to interfere with study participation or outcome assessment.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07600957 clinical trial?
This trial is open to female participants only, aged 35 Years or older, up to 55 Years, studying Radio Dermatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07600957 currently recruiting?
Yes, NCT07600957 is actively recruiting participants. Contact the research team at Marwa.elsayed@pt.bsu.edu.eg for enrollment information.
Where is the NCT07600957 trial being conducted?
This trial is being conducted at Banī Suwayf, Egypt.
Who is sponsoring the NCT07600957 clinical trial?
NCT07600957 is sponsored by Beni-Suef University. The trial plans to enroll 60 participants.