Prospective Study of Symptoms Related to Oxaliplatin-based Regimens in the Treatment of Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 509
- 试验地点
- 1
- 主要终点
- Association between inflammatory cytokines and development of treatment-related symptom burden in colorectal cancer patients
研究概览
简要总结
The goal of this research study is to learn more about the pain and/or other symptoms that patients may experience within five years from CRC diagnosis. Researchers also want to learn how genetic differences may affect the symptoms patients experience from cancer and cancer therapy.
详细描述
If you agree to take part in this study, you will complete 5 questionnaires during a regularly scheduled visit. The questionnaires are designed to measure pain and other symptoms, your mood, and your quality of life.
You will also give a tissue sample by inserting a cotton tipped swab into your mouth and rubbing firmly against the inside of your cheek or underneath your lower or upper lip for about 1 minute at the most.
Completing the 5 questionnaires and the swab sample should take about 30 minutes.
Length of Study:
After you complete the questionnaires and the swab sample collection, your active participation in this study will be over.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with colorectal cancer meeting one of the following criteria:
- •naive to oxaliplatin or to any microtubule stabilizing agents (e.g. Taxol, Abraxane, Ixabepilone) but scheduled for combined oxaliplatine chemotherapy (longitudinal study cohort 1); or
- •during first 5 years from colorectal cancer diagnosis (cross-sectional study cohort). This second cohort may include patients with colorectal cancer from the original 12-month study (the longitudinal cohort), both those who completed the study and those who dropped out. It may also include new patients who did not participate in the longitudinal phase of the study.
- •Patients >= 18 years old.
- •Patients who speak English or Spanish.
排除标准
- •Cohort 1 patients with a neuropathy score of 1 or greater on the NCI's Common Terminology Criteria (CTCv3.0).
- •Patients who do not understand the intent of the study.
- •Cohort 1 patients unable to use the interactive voice response (IVR) system due to physical limitations (e.g., hearing impairment).
- •Cohort 1 patients with a history of inflammatory bowel disease.
结局指标
主要结局
Association between inflammatory cytokines and development of treatment-related symptom burden in colorectal cancer patients
时间窗: 5 Years
次要结局
- Neurocognitive and neuropsychiatric symptoms in colorectal cancer patients(Neuropsychological test battery at baseline and 3 + 6 month follow ups)
- Primary afferent function in colorectal cancer patients receiving chemotherapy by quantitative sensory testing over time(5 Years)