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治験 NCT05930496（対象：ステージII大腸がんAJCC v8、ステージIII大腸癌AJCC v8、大腸癌）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
Evaluating the Effects of an Exercise Intervention on the Gut Microbiota in Stage II-III Colorectal Cancer Survivors
ARM A: Patients receive the supervised exercise intervention 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 a session of supervised exercise followed by 7 weeks of tele-coaching sessions. Patients also undergo collection of blood samples on study.
A Randomized Controlled Trial Testing the Effects of an Exercise Intervention on the Gut Microbiota in Colorectal Cancer Survivors: A Pilot and Feasibility Study
- RG1123467
- NCI-2023-03747 (登録識別子) (CTRP (Clinical Trial Reporting Program))
- P30CA015704 (米国NIHの助成金/契約)
- 20059 (その他の識別子) (Fred Hutch/University of Washington Cancer Consortium)
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Arm A (exercise intervention) Patients receive the supervised exercise intervention over 8 weeks on study. Patients also undergo collection of blood samples at baseline and week 8. | 生体試料採取 Undergo collection of blood samples 運動介入 Receive exercise intervention インタビュー Ancillary studies アンケート管理 Ancillary studies |
実薬対照薬Arm B (waitlist control) Patients receive health-related information for 8 weeks on study. Patients are then offered a session of supervised exercise followed by 7 weeks of tele-coaching sessions. Patients also undergo collection of blood samples at baseline and week 8. | 生体試料採取 Undergo collection of blood samples 運動介入 Receive tele-coaching intervention 健康教育 Receive health-related information インタビュー Ancillary studies アンケート管理 Ancillary studies |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Recruitment | Recruitment (accrual rate) will be assessed to determine feasibility. Will be summarized using descriptive statistics. | Up to 8 weeks |
Adherence | Adherence will be measured by session attendance in the intervention arm to determine feasibility. Will be summarized using descriptive statistics. | Up to 8 weeks |
Retention | 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. | Up to 8 weeks |
Acceptability | 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. | Up to 8 weeks |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Effects of an 8 week supervised exercise intervention on fecal concentrations of butyrate | Will be summarized using descriptive statistics, and statistical differences between study arms will be assessed via linear regression models with adjustment for baseline outcome values and stratification factors. | At 8 weeks |
Effects of an 8 week supervised exercise intervention on fecal concentrations of other short chain fatty acids | Will be summarized using descriptive statistics, and statistical differences between study arms will be assessed via linear regression models with adjustment for baseline outcome values and stratification factors. | At 8 weeks |
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) 18.5-30 kg/m^2
Able to understand and willing to sign written informed consent in English
Access to phone for study contacts
Be willing and able to attend the 24 sessions at the Fred Hutch Exercise Research Center Shared Resource
Access to internet
Willingness to participate in all study activities
Completion of all run-in activities
Participants must not be active smokers within the past 30 days. Active smoking is defined as any smoking (of cigarettes or tobacco products), even a puff
- Participants who smoke are much less likely to engage in healthy lifestyle behaviors, and it is probably more important for participants to stop smoking than it is to change their exercise patterns. If identified as a smoker, the individual will be referred to the local resources, Washington State Quitline (1-800-QUIT-NOW), ICanQuit.org, Quit2Heal.org, the national resource, Centers for Disease Control and Prevention (CDC) "Quit Now" phone line which supports smoking cessation, or the National Institutes of Health (NIH) quit support website "SmokeFree.gov"
At time of consent, participants must engage =< 60 minutes per week of moderate to vigorous physical activity, as assessed by brief questionnaires at screening and then objectively assessed using accelerometers at baseline
Participants must have an Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status score of 0 or 1 for performance status
Physician approval for participation in an 8-week exercise program
Women must not be pregnant, breastfeeding, or planning to become pregnant
- 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 obese (BMI >= 30.0 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
- Active smokers within the past 30 days
- Women who are pregnant, breastfeeding, or planning to become pregnant
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