Application of Chinese Herbal Complementary and Alternative Medicine (CAM) to Improve Human Health and to Further Botanical and Horticultural Sciences
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Proportion of patients free of clinically relevant skin toxicities
研究概览
简要总结
The purpose of this research is to study a Chinese herbal Complementary and Alternative Medicine (CAM) product for the temporary relief of pain and itching after radiotherapy (RT). This is an over-the-counter product with 1% menthol as an active ingredient.
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
- •Female subjects with newly diagnosed breast carcinoma
- •> 18 years of age
- •Post-mastectomy with or without reconstruction
- •Stage II-IIIb with any receptor status
- •All races and ethnicities are eligible
- •Patients must be able to consent in English or Spanish
- •Plan to receive adjuvant radiotherapy to the chest wall +/- regional lymph nodes
- •RT will involve standard fractionation use of 3D conformal or Intensity-modulated RT (IMRT)
- •Willing to sign protocol consent form
- •Patients are allowed to receive adjuvant hormonal therapy and/or targeted therapies such as trastuzumab prior to, during and/or after radiation therapy.
- •Patients may receive chemotherapy before or after radiation therapy
排除标准
- •Prior radiation to the involved breast or chest wall
- •Concurrent chemotherapy
- •Unable or unwilling to sign informed consent
- •Unable to speak English or Spanish
- •Pregnant women
- •Clinical or pathologic stage T4
- •Metastatic disease
- •Connective tissue disorder including Systemic Lupus Erythematosus and Scleroderma
研究组 & 干预措施
CAM arm
Participants will be given the CAM intervention during scheduled, standard of care radiotherapy (up to 6 weeks) and 8-12 weeks (weeks 14-18) after radiotherapy.
干预措施: Complementary and alternative medicine (CAM) (Other)
结局指标
主要结局
Proportion of patients free of clinically relevant skin toxicities
时间窗: Up to 18 weeks.
Clinically relevant skin toxicities - Grade 2 with moist desquamation or Grade 3 or higher using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) as evaluated by the treating clinician.
次要结局
- SD-16 scores(Up to 18 weeks.)
- Functional Assessment of Cancer Therapy-Breast (FACT-B) scores(Up to 18 weeks.)
- High-sensitivity C-reactive protein (hsCRP) values(Up to 6 weeks)
研究者
Jennifer Hu
Professor
University of Miami