Polarized Light Therapy for Radiation Dermatitis in Breast Cancer (PLARD-BREAST)
Efficacy of Polarized Polychromatic Light Therapy on Acute Radiation Dermatitis in Breast Cancer Patients: A Randomized Controlled Trial
調査の概要
状態
詳細な説明
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:
- Polarized light therapy plus Standard skin care.
- 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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Marwa Elsayed Mohamed Lecturer, Ph.D
- 電話番号：01141825442
- メール：Marwa.elsayed@pt.bsu.edu.eg
研究場所
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Banī Suwayf、エジプト
- 募集
- Out patient clinic , faculty of Physical Therapy, Beni Sueif university
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コンタクト：
- Marwa Elsayed Mohamed Lecturer, Ph.D
- 電話番号：01141825442
- メール：Marwa.elsayed@pt.bsu.edu.eg
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-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
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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.
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.
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他の：Standard Care Alone
Participants will receive standard institutional skin care management during radiotherapy.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Ultrasound Skin Thickness
時間枠：Baseline, Week 2, Week 4, Week 6, Week 8, and 2-month follow-up.
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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.
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Baseline, Week 2, Week 4, Week 6, Week 8, and 2-month follow-up.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Radiation Therapy Oncology Group (RTOG) Severity
時間枠：Baseline, Week 2, Week 4, Week 6, Week 8, and 2-month follow-up.
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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.
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Baseline, Week 2, Week 4, Week 6, Week 8, and 2-month follow-up.
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- Polarized light Dermatitis 26
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
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