Pilot Study: KeraStat(R) Cream for Radiation Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Radiation Therapy Oncology Group Skin Toxicity Scoring
研究概览
简要总结
The primary objectives of the proposed research are to evaluate patient use of KeraStat Cream and collect data to inform a larger future trial.
详细描述
The primary objectives of the proposed research are to evaluate patient use of KeraStat Cream and collect data to inform a larger future trial.
The secondary objectives are to assess the safety and tolerability of KeraStat Cream in subjects at risk of radiation dermatitis, to assess the effectiveness of KeraStat Cream and how that compares to the current standard of care, and to estimate the amount of KeraStat Cream used per patient and coverage on skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 70
- •Diagnosis of breast cancer and scheduled to receive 4 to 6 weeks of radiation therapy (radiation dose of 42 Gy or more)
- •Able and willing to sign protocol consent form
- •Able and willing to document symptoms and treatment details as often as needed, not to exceed daily notes
- •Able and willing to have photographs of the affected area taken regularly
排除标准
- •Women who are pregnant, lactating/nursing or plan to become pregnant
- •Previous radiation therapy to the area to be treated with radiation therapy
- •Receiving palliative radiation therapy
- •Unhealed or infected surgical sites in the irradiation area
- •Patients undergoing cytotoxic chemotherapy or concurrent Herceptin as part of overall treatment plan (tamoxifen/aromatase inhibitor allowed)
- •Use of oral corticosteroids or topical corticosteroids in the irradiation area
- •Autoimmune disease
- •Skin disease in target irradiation area
- •Known allergy to the standard of care or ingredients in KeraStat Cream
结局指标
主要结局
Radiation Therapy Oncology Group Skin Toxicity Scoring
时间窗: Baseline (Visit 1), Weekly Visits throughout RT (Visits 2-6), Final Visit approximately 6 weeks post-RT (Visit 7). Subject study duration 8-12 weeks.
The RTOG will be used to track skin reactions to radiation therapy. No toxicity is considered a 0, while massive toxicity is considered a 4. Data will be aggregated across groups at each time point.
Dermatology Life Quality Index
时间窗: Baseline (Visit 1), Weekly Visits throughout RT (Visits 2-6), Final Visit approximately 6 weeks post-RT (Visit 7). Subject study duration 8-12 weeks.
The DLQI measures the impact of dermatological conditions on a patient's quality of life. The DLQI is scored by summing the score of each question (answered from not at all, 0, to very much, 3). The maximum is 30 and the minimum is 0. The higher the score, the greater the impairment of quality of life. Data will be aggregated across treatment groups.
次要结局
- Number of Participants With Adverse Events(Baseline (Visit 1), Weekly Visits throughout RT (Visits 2-6), Final Visit approximately 6 weeks post-RT (Visit 7). Subject study duration 8-12 weeks.)