NCT02250053已完成不适用
The COURAGE Trial: Colon Recurrence and Aerobic Exercise: A Feasibility Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- 1. The biological efficacy of aerobic exercise on soluble intercellular adhesion molecule-1 (sICAM-1), and soluble vascular adhesion molecule-1 (sVCAM-1) prognostic biomarkers.
研究概览
简要总结
Despite the success of surgery and chemotherapy among people with colon cancer, 30-50% of patients develop recurrent disease. Physical activity has emerged as a potential lifestyle intervention to reduce cancer recurrence and improve survival among people with colon cancer (CC). This pilot study aims to identify the dose-response effects of aerobic exercise on molecular and cellular pathways associated with physical activity and CC outcomes among patients with stage II and III CC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
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
- •histologically confirmed TNM stage II-III CC;
- •completed surgical resection and adjuvant chemotherapy (if applicable) within 1-24 months before entering the study;
- •≤120 min/wk of self-reported moderate or vigorous intensity physical activity using the Paffenbarger physical activity questionnaire;
- •age ≥18 years;
- •written physician approval;
- •no additional surgery planned within the 6-month intervention (including colostomy reversal);
- •ability to walk unaided for 6-minutes;
- •no contraindications to exercise using the PA readiness questionnaire (PAR-Q), unless physician approves participation with specific knowledge of this contraindication.
排除标准
- •history of another primary invasive cancer (other than non-melanoma skin-cancer);
- •evidence of metastatic CC (i.e., TNM M1);
- •planning to receive any additional adjuvant chemotherapy;
- •pregnant or breast feeding;
- •unable to provide baseline blood sample;
- •cardiac conditions, including the following:
- •myocardial infarction or coronary revascularization procedure within prior 3 months;
- •uncontrolled hypertension (systolic ≥180 mmHg or diastolic ≥100 mmHg);
- •high-risk or uncontrolled arrhythmias;
- •clinically significant valvular disease;
- •decompensated heart failure;
- •known aortic aneurysm;
- •any other condition that may impede testing of the study hypothesis or make it unsafe to engage in the exercise program (determined by the investigative team).
结局指标
主要结局
1. The biological efficacy of aerobic exercise on soluble intercellular adhesion molecule-1 (sICAM-1), and soluble vascular adhesion molecule-1 (sVCAM-1) prognostic biomarkers.
时间窗: 2 years
次要结局
- Exercise adherence, quantified as the percentage of total dose completed relative to the total dose prescribed during the six-month study;(6 months)
- Fasting insulin measured at baseline and six-months;(six months)
- Circulating tumor cells measured at baseline and six-months.(six months)
- Visceral adipose tissue and anthropometric measures at baseline and six-months;(6 months)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Diagnostic and Prognosis Value of Circulating DNA for CRC Patients' Surveillance After Curative TreatmentColorectal CancerNCT02813928University Hospital, Limoges473
招募中
1 期
The Efficacy of JS001 Combined With Chemotherapy in Patients With Locally Advanced Colon CancerColonic NeoplasmsChemotherapy EffectNCT03985891Xiangya Hospital of Central South University40
已完成
1 期
Celebrex With Preoperative Chemoradiation - Rectal CancerColorectal NeoplasmsNCT00188565University Health Network, Toronto39
招募中
不适用
Predictors of Disease Recurrence After Curative Surgery for Stage I Colon CancerColon Cancer Stage IColon CancerNCT05726188Azienda Ospedaliera Universitaria Integrata Verona2,000
已完成
不适用
Survival Benefit of Primary Tumour Resection Compared to Systemic Therapy Alone in Stage IV Colorectal Cancer PatientsNeoadjuvant Systemic TherapyColorectal CancerNCT06326619Medizinische Hochschule Brandenburg Theodor Fontane480