A Randomized Controlled Trial Testing the Effects of an Exercise Intervention on the Gut Microbiota in Colorectal Cancer Survivors: A Pilot and Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Adherence
研究概览
简要总结
This trial evaluates the effects a moderate-to-vigorous exercise intervention has on the bacterial make-up of the gastrointestinal tract (gut microbiota) in survivors of stage II-III colorectal cancer (CRC). Data shows that the gut microbiota composition and function may be drivers of CRC. High levels of exercise are associated with improved CRC prognosis and survival. While data suggests that exercise has the potential to influence gut microbiota composition and function, it is not known whether these effects contribute to improved CRC prognosis. This clinical trial evaluates the effects an exercise intervention has on gut microbiota and how these effects relate to CRC progression and patient-reported outcomes.
详细描述
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive the supervised exercise intervention (in-person or virtual) three times weekly (TID) over 8 weeks on study. Patients also undergo collection of blood samples on study.
ARM B: Patients receive health-related information for 8 weeks on study. Patients are then offered an in-person session of supervised exercise followed by weekly virtual tele-coaching sessions for 7 weeks. Patients also undergo collection of blood samples on study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-70 years of age
- •Previous diagnosis of stage II-III CRC cancer
- •No known current, recurrent, or metastatic disease
- •No comorbid or physical limitations that would limit participation at the discretion of the treating provider
- •At least 60 days to 3 years from last cancer-directed treatment (including surgery, chemotherapy, and radiation. Elective surgery, including ileostomy reversal, is not counted in this timing but patients must be able to eat a normal diet, without post-operative dietary limitations)
- •Body mass index (BMI) 18.5-35 kg/m^2
- •Able to understand and willing to sign written informed consent in English
- •Access to phone for study contacts
- •Access to a smart phone or tablet to connect to the Polar H10 Heart rate sensor during remote exercise sessions and attend virtual exercise sessions
- •Be willing and able to attend up to 24 sessions in-person at the Fred Hutch Exercise Research Center Shared Resource or virtually via phone, Zoom, or Microsoft Teams, based on participant preference
- •Access to internet (internet access may be provided on a case-by-case basis to participants where access to internet would otherwise be the only barrier to participation)
- •Willingness to participate in all study activities
- •Completion of all run-in activities
- •Participants must have an Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status score of 0 or 1 for performance status
- •Women must not be pregnant, breastfeeding, or planning to become pregnant
排除标准
- •Use of oral or intravenous antibiotics, antifungals, or antiparasitics during the past 6 months
- •Presence of an ileostomy or colostomy because of known changes to the gut microbiome with ileostomies and colostomies
- •Current status of underweight (BMI < 18.5 kg/m^2) or class II/III obesity (BMI ≥ 35.0 kg/m^2)
- •Presence of inflammatory bowel diseases such as Crohn's disease or ulcerative colitis as these are known to baseline have differences in gut microbiome composition
- •Women who are pregnant, breastfeeding, or planning to become pregnant
- •Physician notification to not approach patient for the study
研究组 & 干预措施
Arm A (exercise intervention)
Patients receive the supervised exercise intervention (in-person or virtual) TID over 8 weeks on study. Patients also undergo collection of blood samples on study.
干预措施: Exercise Intervention (Other)
Arm A (exercise intervention)
Patients receive the supervised exercise intervention (in-person or virtual) TID over 8 weeks on study. Patients also undergo collection of blood samples on study.
干预措施: Interview (Other)
Arm A (exercise intervention)
Patients receive the supervised exercise intervention (in-person or virtual) TID over 8 weeks on study. Patients also undergo collection of blood samples on study.
干预措施: Questionnaire Administration (Other)
Arm B (waitlist control)
Patients receive health-related information for 8 weeks on study. Patients are then offered an in-person session of supervised exercise followed by weekly virtual tele-coaching sessions for 7 weeks. Patients also undergo collection of blood samples on study.
干预措施: Biospecimen Collection (Procedure)
Arm B (waitlist control)
Patients receive health-related information for 8 weeks on study. Patients are then offered an in-person session of supervised exercise followed by weekly virtual tele-coaching sessions for 7 weeks. Patients also undergo collection of blood samples on study.
干预措施: Exercise Intervention (Other)
Arm B (waitlist control)
Patients receive health-related information for 8 weeks on study. Patients are then offered an in-person session of supervised exercise followed by weekly virtual tele-coaching sessions for 7 weeks. Patients also undergo collection of blood samples on study.
干预措施: Health Education (Behavioral)
Arm B (waitlist control)
Patients receive health-related information for 8 weeks on study. Patients are then offered an in-person session of supervised exercise followed by weekly virtual tele-coaching sessions for 7 weeks. Patients also undergo collection of blood samples on study.
干预措施: Interview (Other)
Arm B (waitlist control)
Patients receive health-related information for 8 weeks on study. Patients are then offered an in-person session of supervised exercise followed by weekly virtual tele-coaching sessions for 7 weeks. Patients also undergo collection of blood samples on study.
干预措施: Questionnaire Administration (Other)
Arm A (exercise intervention)
Patients receive the supervised exercise intervention (in-person or virtual) TID over 8 weeks on study. Patients also undergo collection of blood samples on study.
干预措施: Biospecimen Collection (Procedure)
结局指标
主要结局
Adherence
时间窗: Up to 8 weeks
Adherence will be measured by session attendance in the intervention arm to determine feasibility. Will be summarized using descriptive statistics.
Retention
时间窗: Up to 8 weeks
Retention will be measured by completion of all study assessments, including physical activity via accelerometry, 24 hour dietary recalls, and completion of the follow-up data collection at 8 weeks to determine feasibility. Will be summarized using descriptive statistics. Statistical differences in retention rates for each study assessment between study arms will be assessed by logistic regression models and acceptability by linear regression models, with models adjusted for stratification factors.
Acceptability
时间窗: Up to 8 weeks
Acceptability will be measured on a Likert scale in each of a series of questions regarding various aspects of the trial during the exit interview to determine feasibility. Will be summarized using descriptive statistics.
Recruitment
时间窗: Up to 8 weeks
Recruitment (accrual rate) will be assessed to determine feasibility. Will be summarized using descriptive statistics.
次要结局
- Effects of an 8 week supervised exercise intervention on fecal concentrations of butyrate(At 8 weeks)
- Effects of an 8 week supervised exercise intervention on fecal concentrations of other short chain fatty acids(At 8 weeks)