An Efficacy Study of Mepitel Film in the Prophylaxis of Radiation-Induced Skin Reactions in Breast Cancer Patients Undergoing Adjuvant Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Observable differences between treated and non-treated breasts/chest wall
研究概览
简要总结
In patients undergoing adjuvant radiotherapy for breast cancer, radiation-induced skin toxicities are a common occurrence and adversely impact patients' quality of life (QOL). In the last decade, there have been no significant advances in preventing or treating radiation-induced skin toxicities. Recently, a phase III randomized trial by Herst et al. (n=78) in New Zealand showed that the prophylactic use of Mepitel Film reduced skin reaction severity by 92% compared to skin treated only with aqueous cream. Mepitel film has not been widely adopted in North America. To validate the efficacy of the film and guide the development of a larger multi-centre phase II study, a pilot study testing the efficacy of the film is proposed. In the study, 30 patients will have the film applied on their breast for the duration of radiation treatment and their skin reactions will be assessed throughout the treatment and after the treatment. The investigators hypothesize that the severity and incidence rates of skin reactions for patients using Mepitel film will be lower when compared to real world data from our centre, and that cosmetic outcomes will be improved with the film.
详细描述
In patients undergoing adjuvant radiotherapy for breast cancer, radiation-induced skin toxicities are a common occurrence and adversely impact patients' quality of life (QOL). Patients with large breasts or patients receiving chest wall radiation may be more likely to have worse skin reactions following radiation. In the last decade, there have been no significant advances in preventing or treating radiation-induced skin toxicities. Recently, a phase III randomized trial by Herst et al. (n=78) in New Zealand showed that the prophylactic use of Mepitel Film prevented moist desquamation (26% vs. 0%, p < 0.001) and reduced skin reaction severity by 92% (p < 0.001) compared to skin treated only with aqueous cream. Another study by Moller et al. (n=101) in Denmark reported a non-significant improvement in observer-rated radiation dermatitis with the film (p=0.1) compared to cream, and significant improvements in several patient-reported outcomes. Moreover, patients with breast cancer complain of hyperpigmentation in the radiated area during and after radiation.
Mepitel Film has not been widely adopted in North American clinical practice. To further study and validate the efficacy of Mepitel Film in preventing acute skin reactions caused by breast radiation and elucidate its efficacy in preventing poor cosmetic outcomes, a phase II efficacy study of three patient populations will be conducted:
- Patients with large breasts
- Patients with small or medium sized breasts
- Patients with chest wall radiation
The results of the phase II efficacy study can guide the development of a subsequent multi-centre phase II and III trials to further validate the use of Mepitel film and increase its adoption rate.
The primary objective is to examine the efficacy of Mepitel film in the prophylaxis of radiation-induced skin reactions. Secondary objectives include an evaluation of patient-reported and healthcare professional (HCP)-reported skin toxicities including moist desquamation with the use of Mepitel film.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Patient will receive adjuvant breast or chest wall radiation
- •Post-lumpectomy patients with band size of at least 36 inches or cup size of D or larger will be part of the large breast cohort
- •Post-lumpectomy patients that do not meet this size requirement will be part of the small or medium sized breast cohort
- •Post-mastectomy patients are part of the chest wall radiation cohort
- •Can communicate in English or be aided by a hospital translator
排除标准
- •Patient had previous radiation therapy to the treatment area
- •Patient had breast reconstruction
- •Patient has a Karnofsky Performance Status score <70
- •Patient will have radiation treatment in prone or reverse decubitus positions
- •Patient will receive partial breast external beam radiation or brachytherapy
- •Patient will receive radiation to the supraclavicular region
结局指标
主要结局
Observable differences between treated and non-treated breasts/chest wall
时间窗: Within 3 months following radiation
Determined by a cosmetic dermatologist from photographs of the treated and non-treated breast/chest wall.
次要结局
- Patient reports of acute skin toxicity(Within 3 months following radiotherapy)
- Clinician reports of late skin toxicity(6 months following radiotherapy)
- Degree of acute skin toxicity and interference with daily functioning(Within 3 months following radiotherapy)
- Long-term changes in skin pigmentation(Changes from baseline to 6 months following radiotherapy)
- Late changes in breast cosmesis(6 months following radiotherapy)
- Clinician grading of late skin toxicity(6 months following radiotherapy)
- Patient reports of late skin toxicity(6 months following radiotherapy)
- Degree of late skin toxicity and interference with daily functioning(6 months following radiotherapy)
- Acute changes in breast cosmesis(Within 3 months following radiotherapy)
- Clinician reports of acute skin toxicity(Within 3 months following radiotherapy)
- Clinician grading of acute skin toxicity(Within 3 months following radiotherapy)
- Film Integrity Assessment(Until film is removed, 2 weeks following radiotherapy)
研究者
Dr. Edward Chow
Principal Investigator
Sunnybrook Health Sciences Centre