The Exercise And Colorectal Cancer Treatment (EXACT) Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The Percentage Change in High-sensitivity C-reactive Protein
研究概览
简要总结
This study will examine the biologic processes through which exercise may prevent disease recurrence in patients who have completed treatment for colorectal cancer.
详细描述
This randomized trial will examine the biological effects of 12-weeks of moderate-intensity aerobic exercise versus wait-list control in 60 subjects who have completed standard medical therapy for colorectal cancer. The primary objective is to determine if aerobic exercise can reduce systemic inflammation, quantified using plasma concentrations of high-sensitivity C-reactive protein and interleukin-6. The secondary objectives are to determine if exercise can reduce: 1) insulin resistance quantified using an oral glucose tolerance test, and; 2) circulating tumor cells quantified using a microfluidic antibody-mediated capture platform. The exploratory objective is to determine if exercise can improve mitochondrial respiration rates and fatty acid oxidation in peripheral blood mononuclear cells and tumor fraction.
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 (Investigator, Outcomes Assessor)
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
- •Age ≥18 years
- •Histologically-confirmed stage I-III colorectal cancer
- •Completed surgical resection
- •Completed chemotherapy (if applicable)
- •Completed radiotherapy (if applicable)
- •Provide written approval by physician or other qualified healthcare provider
- •No planned major surgery during the study period (including colostomy reversal; chemotherapy infusion port removal is permitted)
- •Readiness to exercise [as determined by a modified version the Physical Activity Readiness Questionnaire (PAR-Q)
- •Allow the collection and storage of specimens and data for future use
- •Willing to be randomized
排除标准
- •Evidence of metastatic colon cancer
- •Concurrently actively treated other cancer (except non-melanoma skin cancer or in situ cancers)
- •Currently enrolled in another clinical trial of weight loss, physical activity, or dietary intervention
- •Current body mass greater than or equal to 181 kg
- •Unable to provide a baseline fasting blood sample
- •Unable or unwilling to give informed consent
- •Unable or unwilling to be randomized
- •Or any other condition that may impede testing of the study hypothesis or make it unsafe to engage in the exercise program (as determined by the investigative team)
结局指标
主要结局
The Percentage Change in High-sensitivity C-reactive Protein
时间窗: Baseline, 12 weeks
The Percentage Change in Interleukin-6
时间窗: Baseline, 12 weeks
次要结局
- The Percentage Change in Soluble Tumor Necrosis Factor-alpha Receptor Two(Baseline, 12 weeks)
- The Change in Circulating Tumor Cells Per mL Whole Blood(Baseline, 12 weeks)
- Insulin Resistance(Baseline, 12 weeks)
研究者
Justin Brown
Adjunct Associate Professor
Pennington Biomedical Research Center