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Evaluating the Effects of an Exercise Intervention on the Gut Microbiota in Stage II-III Colorectal Cancer Survivors

Primary Purpose

Stage II Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biospecimen Collection
Exercise Intervention
Exercise Intervention
Health Education
Interview
Questionnaire Administration
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stage II Colorectal Cancer AJCC v8

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18-70 years of age Previous diagnosis of stage II-III CRC cancer No known 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 smartphone 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, 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 at time of enrollment Exclusion Criteria: 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 or breastfeeding, or planning to become pregnant

Sites / Locations

  • Fred Hutch/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A (exercise intervention)

Arm B (waitlist control)

Arm Description

Patients receive the supervised exercise intervention over 8 weeks on study. Patients also undergo collection of blood samples at baseline and week 8.

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.

Outcomes

Primary Outcome Measures

Recruitment
Recruitment (accrual rate) will be assessed to determine feasibility. Will be summarized using descriptive statistics.
Adherence
Adherence will be measured by session attendance in the intervention arm to determine feasibility. Will be summarized using descriptive statistics.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
June 26, 2023
Last Updated
August 9, 2023
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05930496
Brief Title
Evaluating the Effects of an Exercise Intervention on the Gut Microbiota in Stage II-III Colorectal Cancer Survivors
Official Title
A Randomized Controlled Trial Testing the Effects of an Exercise Intervention on the Gut Microbiota in Colorectal Cancer Survivors: A Pilot and Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive the supervised exercise intervention over 8 weeks on study. Patients also undergo collection of blood samples at baseline and week 8. 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 at baseline and week 8.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage II Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A (exercise intervention)
Arm Type
Experimental
Arm Description
Patients receive the supervised exercise intervention over 8 weeks on study. Patients also undergo collection of blood samples at baseline and week 8.
Arm Title
Arm B (waitlist control)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Biospecimen Collection
Other Intervention Name(s)
Biological Sample Collection, Biospecimen Collected, Specimen Collection
Intervention Description
Undergo collection of blood samples
Intervention Type
Other
Intervention Name(s)
Exercise Intervention
Intervention Description
Receive exercise intervention
Intervention Type
Other
Intervention Name(s)
Exercise Intervention
Intervention Description
Receive tele-coaching intervention
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
Receive health-related information
Intervention Type
Other
Intervention Name(s)
Interview
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Recruitment
Description
Recruitment (accrual rate) will be assessed to determine feasibility. Will be summarized using descriptive statistics.
Time Frame
Up to 8 weeks
Title
Adherence
Description
Adherence will be measured by session attendance in the intervention arm to determine feasibility. Will be summarized using descriptive statistics.
Time Frame
Up to 8 weeks
Title
Retention
Description
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.
Time Frame
Up to 8 weeks
Title
Acceptability
Description
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.
Time Frame
Up to 8 weeks
Secondary Outcome Measure Information:
Title
Effects of an 8 week supervised exercise intervention on fecal concentrations of butyrate
Description
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.
Time Frame
At 8 weeks
Title
Effects of an 8 week supervised exercise intervention on fecal concentrations of other short chain fatty acids
Description
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.
Time Frame
At 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-70 years of age Previous diagnosis of stage II-III CRC cancer No known 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 smartphone 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, 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 at time of enrollment Exclusion Criteria: 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 or breastfeeding, or planning to become pregnant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heather Greenlee
Phone
206-667-4502
Email
hgreenlee@fredhutch.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Greenlee
Organizational Affiliation
Fred Hutch/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutch/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Greenlee
Phone
206-667-4502
Email
hgreenlee@fredhutch.org
First Name & Middle Initial & Last Name & Degree
Heather Greenlee

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluating the Effects of an Exercise Intervention on the Gut Microbiota in Stage II-III Colorectal Cancer Survivors

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