A Phase III Study of the Impact of a Physical Activity Program on Disease-Free Survival in Patients With High-Risk Stage II or Stage III Colon Cancer: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 889
- 试验地点
- 91
- 主要终点
- Disease-free survival
研究概览
简要总结
RATIONALE: Participating in a physical activity program designed to increase free time physical activity and receiving written health education materials may influence the chance of cancer recurring as well as impact on physical fitness, psychological well-being and the quality of life of patients who have undergone surgery and chemotherapy for colon cancer. It is not yet known whether giving a physical activity program together with health education materials is more effective than giving health education materials alone for patients who have undergone colon cancer treatment.
PURPOSE: This randomized phase III trial is studying a physical activity program given together with health education materials to see how well it works compared with giving health education materials alone for patients who have undergone treatment for high-risk stage II or stage III colon cancer.
详细描述
OBJECTIVES:
Primary
- To compare the disease-free survival (DFS) of medically fit patients who have completed surgical resection and adjuvant chemotherapy for high-risk stage II or stage III colon cancer when administered a physical activity program with general health education materials vs general health education materials alone.
Secondary
- To compare the two intervention arms with respect to overall survival (OS); patient-reported outcomes using the SF-36, FACIT-F, PSQI, and HADS questionnaires; objective markers of physical fitness using body mass index, hip and waist circumference, submaximal exercise testing, and the Seniors' Fitness Test; physical activity behavior using the Total Physical Activity Questionnaire (TPAQ); safety profile as assessed by NCI CTCAE version 3.0; serum levels of insulin (i.e., IGF-1, IGF-2, and IGFBP3); cytokine levels (i.e., IL-1β, IL-6, IL-2, IL-4, IL-8, IL-10, IL-12, TNF-α, IFN-γ, and GM-CSF) and C-reactive protein levels; economic evaluations including cost-effective and cost-utility analyses; and predictors of physical activity adherence using the Social-Cognitive Determinants of Exercise Measure questionnaire.
- To evaluate the potential prognostic associations of the serum levels of insulin, IGF-1, IGF-2, IGFBP3, blood glucose, cytokines (i.e., IL- 1β, IL-6, IL-2, IL-4, IL-8, IL-10, IL-12, TNF-α, IFN-γ, and GM-CSF), and C-reactive protein with DFS, OS, level of physical activity, and level of fatigue in these patients.
- To evaluate the potential prognostic associations of age, gender, country, incremental increase in physical activity, and change in cardiovascular fitness with DFS, OS, level of fatigue, and quality of life in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •DISEASE CHARACTERISTICS:
- •Completely resected histologically confirmed adenocarcinoma of the colon
- •High-risk stage II disease, including one of the following:
- •T4 lesions
- •Less than 12 sampled lymph nodes
- •Poorly differentiated histology
- •Stage III disease, defined as having at least one pathologically confirmed positive lymph node or one pathologically confirmed positive tumour deposit.
- •Synchronous primary colon cancer allowed
- •Adjuvant chemotherapy treatment for colon cancer with a 5-fluorouracil- based regimen received with an intent to provide a complete course of treatment. While one current standard is 24 weeks of treatment, patients who are pre-planned to receive a shorter duration of chemotherapy, including as part of a research study will also be permitted. The actual treatment received may be less than 24 weeks; participants must have received a minimum of one treatment cycle.
- •Chemotherapy must have been completed (i.e. last dose received) a minimum of 60 days and a maximum of 180 days prior to registration.
- •Carcinoembryonic antigen (CEA) ≤ 5 μg/L
- •Current physical activity levels do not meet the recommended guidelines (≥ 150 minutes of moderate-to-vigorous or ≥ 75 minutes of vigorous physical activity/week) as calculated using the Leisure Time Exercise Questionnaire (LTEQ)
- •Completion of chest x-ray or CT, and CT, MRI or ultrasound of abdomen within 60 days of registration; these imaging tests must not show evidence of metastatic or locally-recurrent colon cancer.
- •Complete one of the following: (a) at least 2 stages of the submaximal exercise test with an acceptable heart rate and blood pressure response as defined in Appendix XII or (b) the 6 minute walk test with an acceptable heart rate and blood pressure response
- •No rectal cancer
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-1
- •Absolute granulocyte count ≥ 1,000/mm³
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 100 g/L
- •Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
- •Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •Alkaline phosphatase < 2.5 times ULN
- •ALT < 2 times ULN
- •Not pregnant or planning to become pregnant within the next 3 years
- •Able (i.e., sufficiently fluent) and willing to effectively communicate with the physical activity consultant affiliated with the originating cancer center
- •Able (i.e., sufficiently fluent in English or French) and willing to complete the patient-reported outcome questionnaires, social determinants of exercise measurement, health economics, and physical activity questionnaires and logs
- •Able to complete the baseline exercise test
- •No significant comorbid conditions precluding participation in a physical activity program as determined by the investigator
- •Likely to participate in a physical activity program, as assessed by the investigator
- •No history of other malignancies, except adequately treated nonmelanoma skin cancer, curatively treated in situ cancer of the cervix, other solid tumors, Hodgkin lymphoma, or non-Hodgkin lymphoma curatively treated with no evidence of disease for > 5 years
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior radiotherapy as a component of treatment for primary tumor
- •No concurrent treatment with additional chemotherapy or radiation
- •No concurrent treatment with any medications deemed by the investigator as likely to preclude participation in a physical activity program
- •No concurrent anticancer treatment including chemotherapy, biological, or targeted agents
排除标准
- 未提供
研究组 & 干预措施
Physical Activity Program + General Health Education Materials
Intervention Arm
干预措施: exercise intervention (Behavioral)
Physical Activity Program + General Health Education Materials
Intervention Arm
干预措施: counseling intervention (Other)
Physical Activity Program + General Health Education Materials
Intervention Arm
干预措施: educational intervention (Other)
Physical Activity Program + General Health Education Materials
Intervention Arm
干预措施: laboratory biomarker analysis (Other)
Physical Activity Program + General Health Education Materials
Intervention Arm
干预措施: questionnaire administration (Other)
Physical Activity Program + General Health Education Materials
Intervention Arm
干预措施: study of socioeconomic and demographic variables (Other)
Physical Activity Program + General Health Education Materials
Intervention Arm
干预措施: fatigue assessment and management (Procedure)
Physical Activity Program + General Health Education Materials
Intervention Arm
干预措施: quality-of-life assessment (Procedure)
Physical Activity Program + General Health Education Materials
Intervention Arm
干预措施: Fitness testing (Other)
General Health Education Materials
Control Arm
干预措施: laboratory biomarker analysis (Other)
General Health Education Materials
Control Arm
干预措施: questionnaire administration (Other)
General Health Education Materials
Control Arm
干预措施: study of socioeconomic and demographic variables (Other)
General Health Education Materials
Control Arm
干预措施: fatigue assessment and management (Procedure)
General Health Education Materials
Control Arm
干预措施: quality-of-life assessment (Procedure)
General Health Education Materials
Control Arm
干预措施: Educational Intervention (Other)
General Health Education Materials
Control Arm
干预措施: Fitness testing (Other)
结局指标
主要结局
Disease-free survival
时间窗: 10 years
Disease-free Survival
时间窗: 5 Years after randomization
Time from randomization to the first event that was either recurrent (local or distant) colon cancer, a new primary colorectal cancer, a second primary cancer, or death from any cause. The outcome for the disease-free survival will be presented as 5 year disease-free survival rate.
次要结局
- Overall survival(10 years)
- Physical activity behavior as assessed by TPAQ(5 years)
- Correlative biological markers including biochemical and molecular markers associated with insulin-related growth factor and cytokines associated with the mechanisms of fatigue(3 years)
- Objective markers of physical fitness (i.e., body mass index, hip and waist circumference, cardiovascular fitness, and physical function)(3 years)
- Patient-reported outcomes, including quality of life, using SF-36, FACIT-F, PSQI, and HADS questionnaires(5 years)
- Safety profile according to NCI CTCAE version 3.0(10 years)
- Economic evaluations including cost-effective analysis and cost utility analysis(5 years)
- Predictors of physical activity adherence as assessed by Social Cognitive Determinants of Exercise questionnaire(3 years)
- Overall Survival(8 years after randomization.)