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

2026年5月21日 更新者：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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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:

  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.

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 埃及
      • Banī Suwayf、埃及
        • 招聘中
        • Out patient clinic , faculty of Physical Therapy, Beni Sueif university
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
设备：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.
其他：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.
其他：Standard Care Alone
Participants will receive standard institutional skin care management during radiotherapy.
其他：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Ultrasound Skin Thickness
大体时间：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.

次要结果测量

结果测量
措施说明
大体时间
Radiation Therapy Oncology Group (RTOG) Severity
大体时间：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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Beni-Suef University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月21日

初级完成 (估计的)

2027年1月15日

研究完成 (估计的)

2027年1月31日

研究注册日期

首次提交

2026年5月15日

首先提交符合 QC 标准的

2026年5月15日

首次发布 (实际的)

2026年5月22日

研究记录更新

最后更新发布 (实际的)

2026年5月26日

上次提交的符合 QC 标准的更新

2026年5月21日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • Polarized light Dermatitis 26

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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