Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Survivors | — | UNRESOLVED | — |
| Polarized Light | — | UNRESOLVED | — |
| Radio Dermatitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Polarized Polychromatic Light Therapy | Device | — | UNRESOLVED |
| Standard Skin Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Polarized Light Therapy + Standard Care
- description
- Participants will receive polarized polychromatic non-coherent light therapy combined with routine institutional skin care management during the radiotherapy course.
- interventionNames
- Device: Polarized Polychromatic Light Therapy
- Other: Standard Skin Care
- type
- OTHER
- label
- Standard Care Alone
- description
- Participants will receive standard institutional skin care management during radiotherapy.
- interventionNames
- Other: Standard Skin Care
Primary outcomes (1)
- measure
- Ultrasound Skin Thickness
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 55 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available