A Phase 1, Randomized, Double Blinded, Placebo Controlled Study of the Safety and Efficacy of a Caffeine-based Antifibrosis Cream in Patients With Breast Cancer Undergoing Radiation Therapy
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Standard Toxicity Scoring
研究概览
简要总结
The purpose of the study is to evaluate whether a caffeine-based cream can reduce the rates of reconstructive complications in patients with tissue expander based reconstruction requiring post-mastectomy radiation therapy when compared to a placebo cream.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has histologically-confirmed carcinoma of breast (all subtypes are permitted)
- •Patient has undergone mastectomy with tissue expander-based reconstruction and require post-mastectomy radiation therapy (PMRT) per the - Stage DCIS (0) -III breast cancer, excluding any patients with inflammatory breast cancer at presentation.
- •Patient will receive irradiation of the chest wall. Additional fields to treat the regional nodes including the supraclavicular / axillary and/or internal mammary chains is allowed but not required. If a patient requires a boost field to the chest wall, scar and/or nodal region this is allowed.
排除标准
- •Patient with skin changes or inflammatory carcinoma at presentation Patient has (cT4b-d)
- •unhealed wound in the radiation field
- •Patient has allergy to Caffeine
- •Patient has systemic lupus erythematosus or scleroderma that increases the risk of radiation dermatitis development
- •Patient will receive concurrent chemotherapy with radiation. (Patient is allowed to take concurrent hormonal therapy or Trastuzumab)
- •Planned accelerated or hypofractionated fractionation.
- •Previous radiation to the ipsilateral breast or chest wall or thoracic region.
- •Anyone who will require bolus use during radiation (per physician discretion) as this will increase rates of acute toxicity interfering with measurement of the primary study endpoint.
- •All pre-menopausal women will require a urine qualitative pregnancy test to exclude pregnancy. Pregnant women will be excluded from the study.
研究组 & 干预措施
Caffeine Based Cream
caffeine based cream during and for 4 weeks following radiation
干预措施: Caffeine anhydrous 5% added to Lipoderm Cream Base. (Drug)
Placebo
placebo cream during and for 4 weeks following radiation
干预措施: Lipoderm Cream Base (Other)
结局指标
主要结局
Standard Toxicity Scoring
时间窗: 4 Years
The US National Cancer Institute developed the Common Terminology Criteria for Adverse Events (CTCAE), which was formerly called the Common Toxicity Criteria (CTC), which is a standardized classification of adverse effects in cancer therapy. The current version 5.0 was released in 2017. The criteria uses a grading system of 1 to 5 (e.g. Grade 1 = mild and Grade 5 = death related to AE).
次要结局
未报告次要终点