Polarized Light Therapy for Radiation Dermatitis in Breast Cancer

NCT07600957 | Not Yet Recruiting

• 1 other identifier: Polarized light Dermatitis 26
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Radio Dermatitis; Polarized Light; Breast Cancer Survivors

Keywords

hypo fractionated whole-breast irradiation; radiodermatitis; polarized light therapy; ultrasound scan

Outcome Measures

Primary Outcomes (1)

• Ultrasound Skin Thickness

  Objective assessment of radiation-induced skin structural changes using high-frequency musculoskeletal ultrasound imaging of the irradiated breast region. Dermal thickness measurements (mm) will be performed by the same radiologist for both groups throughout the study. A standardized layer of ultrasound gel approximately 1 mm thick will be used as a coupling medium to optimize image acquisition. Measurements will be obtained from the most clinically affected area within the irradiated breast field. To improve accuracy and reliability, the average of three consecutive measurements will be recorded for analysis. Special care will be taken to avoid compression artifacts by gently applying the ultrasound probe to the skin surface with minimal pressure.

  Baseline, Week 2, Week 4, Week 6, Week 8, and 2-month follow-up.

Secondary Outcomes (1)

• Radiation Therapy Oncology Group (RTOG) Severity

  Baseline, Week 2, Week 4, Week 6, Week 8, and 2-month follow-up.

Study Arms (2)

Polarized Light Therapy + Standard Care

EXPERIMENTAL

Participants will receive polarized polychromatic non-coherent light therapy combined with routine institutional skin care management during the radiotherapy course.

Device: Polarized Polychromatic Light Therapy; Other: Standard Skin Care

Standard Care Alone

OTHER

Participants will receive standard institutional skin care management during radiotherapy.

Other: Standard Skin Care

Interventions

Polarized Polychromatic Light Therapy DEVICE

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.

Polarized Light Therapy + Standard Care

Standard Skin Care OTHER

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.

Polarized Light Therapy + Standard Care; Standard Care Alone

Eligibility Criteria

• Age: 35 Years - 55 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Out patient clinic , faculty of Physical Therapy, Beni Sueif university

Banī Suwayf, Egypt

Location

MeSH Terms

Conditions

Radiodermatitis

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Central Study Contacts

Marwa Elsayed Mohamed Lecturer, Ph.D

CONTACT

01141825442; Marwa.elsayed@pt.bsu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors responsible for ultrasound imaging, clinical skin assessment, and data collection will remain blinded to group allocation throughout the study period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical Therapy For Women Health

Model Details: Participants will be randomly allocated in a 1:1 ratio into either an experimental group receiving polarized light therapy in addition to standard skin care or a control group receiving standard skin care alone throughout the radiotherapy course.

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): May 25, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

EG (1)