Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer: The M&M Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 288
- 主要终点
- Number of Chemotherapy Toxicities (Grade 3 - 5)
研究概览
简要总结
This study will examine the association between low muscle mass (myopenia) at diagnosis and chemotherapy toxicity in older adults with newly diagnosed advanced colorectal cancer.
详细描述
This is a prospective cohort study that examines the impact of myopenia on chemotherapy toxicity in overall survival (OS) in older adults with newly diagnosed metastatic colorectal cancer (CRC) receiving 5-Fluouracil (5FU)systemic chemotherapy. The study also explores the mediating influence of genetic variation in the association between myopenia and chemotherapy toxicity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed metastatic CRC or newly recognized metastatic recurrence of CRC >= to 3 months (12 weeks) from completion of treatment of non-metastatic CRC.
- •Planning to or recently started to undergo undergo immunotherapy and/or 5-FU based chemotherapy as a first line of treatment. 5-FU chemotherapy can be 5-FU alone or in combination with oxaliplatin and/or irinotecan +/- immunotherapy. Capecitabine is also acceptable.
- •Estimated life expectancy >= 6 months.
- •Patients must be able to comprehend English or Spanish (for questionnaire completion).
- •Ability to understand and the willingness to sign a written informed consent document.
- •Patient eligibility is not dependent on BMI or weight. Patients with a significant (+- > 10%) body weight change in the previous 12 months are eligible for this study.
排除标准
- •Patients enrolled on hospice.
- •Prior systemic chemotherapy for metastatic colorectal cancer (ok if adjuvant chemotherapy completed >= 3 months (12 weeks) prior to this disease disease recurrence and treatment).
- •Patients may not be receiving any other investigational agents.
- •No untreated brain metastases. Patients with treated brain metastases are eligible.
- •Patients on or planned to undergo radiation therapy in near future.
研究组 & 干预措施
Adults >= 75 years
Adults 60-74 years
结局指标
主要结局
Number of Chemotherapy Toxicities (Grade 3 - 5)
时间窗: Up to 6 months (after initiation of chemotherapy)
Chemotoxicity will be measured after initiation of chemotherapy using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
次要结局
- Overall Survival(1 year)