Mepitel Film® Prophylaxis For Breast Cancer Patients Receiving Breast Radiotherapy At High Risk For Moist Desquamation: A Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 10
- 主要终点
- Evaluate the efficacy of use of Mepitel Film® in the prevention of grade II or higher radiation epidermitis in high-risk patients undergoing radiotherapy for breast cancer
研究概览
简要总结
The purpose of this research is to evaluate the use of Mepitel Film® in preventing radiation epidermitis in patients receiving radiation treatment for breast cancer. Mepitel® Film is a thin, flexible, waterproof, and breathable film made of a soft silicone layer and polyurethane film. Mepitel ® film is not made with natural rubber latex (NRL). It is FDA approved for the management of superficial wounds, such as superficial burns. As a part of this research study, the Mepitel Film® will be placed prior to participant's first radiation treatment, and will be removed one week following the end of treatment. Throughout the study, information will be collected to analyze at the end of the research study to determine if the Mepitel Film® helps prevent skin breakdown. The subjects will be followed per standard of care and examined for skin redness, warmth or swelling as normally examined and cared for during standard radiation therapy. If radiation burns are noted, the subject will be treated normally and depending on the severity of the radiation burns, may be removed from the study treatment and treated through standard of care.
详细描述
Clinical Phase II trial to determine if Mepitel Film® is a viable prophylactic option for high-risk women undergoing radiotherapy for breast cancer to reduce side effects of radiation on the skin.
The objective of this study is to evaluate the efficacy of use of Mepitel Film® in the prevention of grade II or higher radiation epidermitis in high-risk patients undergoing radiotherapy for breast cancer.
Test Article(s) Mepitel Film ®
The proposed study is a cohort trial of women with breast cancer who are at a high risk of having pain, swelling, inflammation with skin tenderness, skin ulceration, pruritis, and scarring during radiation treatment.
Each subject's participation will last approximately eight weeks. The entire study is expected to last up to 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 18 - 80 years of age
- •Biopsy-proven diagnosis of breast cancer (Stage 0 - II) with the breast tumor completely removed
- •Whole breast or chest wall irradiation with or without ipsilateral axillary radiotherapy
- •Women of child-bearing potential must use an effective form of birth control
排除标准
- •Women who are pregnant or lactating
- •Women with evident skin irritation or skin infection (i.e. active rash, pre-existing dermatitis) or known allergy to adhesives or tapes; or known allergy to the Mepitel Film®
- •Women with a chest abnormality that would preclude application of the Film;
- •Women who in the investigator's opinion are not capable of completing the trial or following trial procedures
结局指标
主要结局
Evaluate the efficacy of use of Mepitel Film® in the prevention of grade II or higher radiation epidermitis in high-risk patients undergoing radiotherapy for breast cancer
时间窗: 7 weeks from initiation
The breast will be photographed and assessed at the beginning of therapy and at weeks 3, 5 and 6 the 3 (which will occur if clinically indicated) and one week following the completion of therapy. At each treatment, the breast will be evaluated by a physician for signs of infection, erythema, induration, dry or wet desquamation or frank skin breakdown, utilizing a Radiation Dermitis scale (NCI CTCAE v4.03) at each visit. The scale ranges from 0 to 4, with 0-being no change, 1-faint erythema or dry desquamation, 2-moderate to brisk erythema, 3-confluent moist desquamation, 4-skin necrosis or ulceration, as assessed by the physician. The primary analysis will be based on the classification of radiation dermatitis from treated and untreated skin at each visit and will be analyzed using a chi-square or Fisher's Exact test as appropriate. Analysis will be stratified by any significant confounding factors or effect modifiers.
次要结局
- Time to healing skin treated with and without the film(7 weeks from initiation)
- Reduction in erythema(7 weeks from initiation)
- Reduction in moist desquamation(7 weeks from initiation)
- Quality of Life (QOL) responses(7 weeks from initiation)
- Time until the onset of erythema(7 weeks from initiation)
研究者
Mark Trombetta, MD
MD, Radiation Oncology
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)