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

21 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Egitto
      • Banī Suwayf, Egitto
        • Reclutamento
        • Out patient clinic , faculty of Physical Therapy, Beni Sueif university
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Dispositivo: 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.
Altro: 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.
Altro: Standard Care Alone
Participants will receive standard institutional skin care management during radiotherapy.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Ultrasound Skin Thickness
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Radiation Therapy Oncology Group (RTOG) Severity
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Beni-Suef University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

21 maggio 2026

Completamento primario (Stimato)

15 gennaio 2027

Completamento dello studio (Stimato)

31 gennaio 2027

Date di iscrizione allo studio

Primo inviato

15 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

15 maggio 2026

Primo Inserito (Effettivo)

22 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Polarized light Dermatitis 26

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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