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Polarized Light Therapy for Radiation Dermatitis in Breast Cancer (PLARD-BREAST)

21. maj 2026 opdateret af: Marwa Elsayed Mohamed, PhD, Beni-Suef University

Efficacy of Polarized Polychromatic Light Therapy on Acute Radiation Dermatitis in Breast Cancer Patients: A Randomized Controlled Trial

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Acute radiation dermatitis is one of the most frequent adverse effects associated with breast cancer radiotherapy and may negatively affect patient comfort, treatment adherence, and quality of life. Clinical manifestations range from mild erythema and dry desquamation to severe moist desquamation and ulceration. Although standard skin care measures are routinely implemented, effective preventive and therapeutic non-invasive interventions remain limited.

Polarized polychromatic non-coherent light therapy has demonstrated anti-inflammatory, microcirculatory, tissue regenerative, and wound-healing effects in several dermatologic and musculoskeletal conditions. However, evidence regarding its efficacy for radiation-induced skin toxicity remains insufficient.

This prospective randomized assessor-blinded controlled trial will investigate the effectiveness of polarized light therapy as an adjunctive supportive treatment for acute radiation dermatitis in women receiving hypo fractionated whole-breast irradiation (40-42.5 Gy in 15-16 fractions over approximately 3 weeks) following breast-lumpectomy for breast cancer.

Participants will be randomly assigned into two parallel groups:

  1. Polarized light therapy plus Standard skin care.
  2. Standard skin care alone. The polarized light intervention will be initiated on the first day of radiotherapy and administered three times weekly throughout the radiotherapy course using the Bioptron Light Therapy System.

The primary outcome will be ultrasound-based dermal thickness changes within the irradiated breast region. Secondary outcomes will include clinical severity of radiation dermatitis using Radiation Therapy Oncology Group (RTOG) criteria Assessments will be conducted at baseline, Week 2, Week 4, Week 6, Week 8, and at 2-month follow-up. The study aims to determine whether polarized light therapy can reduce radiation-induced skin inflammation, delay progression of dermatitis severity, improve symptom burden, and enhance skin recovery compared with standard care alone.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Egypten
      • Banī Suwayf, Egypten
        • Rekruttering
        • Out patient clinic , faculty of Physical Therapy, Beni Sueif university
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Polarized Light Therapy + Standard Care
Participants will receive polarized polychromatic non-coherent light therapy combined with routine institutional skin care management during the radiotherapy course.
Enhed: Polarized Polychromatic Light Therapy
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.
Andet: Standard Skin Care
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.
Andet: Standard Care Alone
Participants will receive standard institutional skin care management during radiotherapy.
Andet: Standard Skin Care
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ultrasound Skin Thickness
Tidsramme: Baseline, Week 2, Week 4, Week 6, Week 8, and 2-month follow-up.
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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Radiation Therapy Oncology Group (RTOG) Severity
Tidsramme: Baseline, Week 2, Week 4, Week 6, Week 8, and 2-month follow-up.
Clinical severity of acute radiation dermatitis will be assessed using the Radiation Therapy Oncology Group (RTOG) acute radiation morbidity scoring criteria. Skin reactions within the irradiated breast area will be evaluated and classified according to the degree of skin irritation and tissue damage as follows: RTOG Grade 0: no visible skin change; Grade 1: mild erythema, epilation, sweating, or dry desquamation; Grade 2: bright or painful erythema, patchy moist desquamation, or moderate edema; Grade 3: confluent moist desquamation extending beyond skin folds and pitting edema; Grade 4: ulceration, necrosis, or bleeding. Assessments will be conducted by a blinded assessor under standardized clinical conditions throughout the study period. Scoring criteria ranging from Grade 0 to Grade 4.
Baseline, Week 2, Week 4, Week 6, Week 8, and 2-month follow-up.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Beni-Suef University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

21. maj 2026

Primær færdiggørelse (Anslået)

15. januar 2027

Studieafslutning (Anslået)

31. januar 2027

Datoer for studieregistrering

Først indsendt

15. maj 2026

Først indsendt, der opfyldte QC-kriterier

15. maj 2026

Først opslået (Faktiske)

22. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Polarized light Dermatitis 26

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