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Exercise for Gut Microbiome in Patients With Young-Onset Colorectal Cancer Undergoing Chemotherapy: The COURAGE Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 50 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 months
  • Procedures mentioned: Blood draws, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The research study procedures include screening for eligibility, blood tests, stool samples, and survey questionnaires."
  • "Participation in this research study will last up to 6 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how exercise affects gut microbes, chemotherapy side effects, and treatment results. It is for people diagnosed with colon or rectal cancer at ages 18–50 who are getting or planning chemotherapy. Participants are placed by chance into an exercise group or a waitlist group.

This research study is a randomized controlled trial that will observe changes in microbiome activity, changes in chemotherapy toxicity, and any changes in treatment outcomes between two groups of participants undergoing chemotherapy with either early-stage or metastatic colorectal cancer. The names of the study groups involved in this study are: * Exercise * Waitlist Control

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Were diagnosed with colon or rectal cancer at ages 18–50, either at an early stage or after it had spread.
  • Are getting or planning to get chemotherapy.
  • Have no plans for major surgery or radiation for at least 12 weeks after joining. Surgery to place a port for treatment is allowed.
  • Do no more than 90 minutes of medium-to-hard exercise each week.
  • Have your cancer doctor's approval for exercise and testing, with no uncontrolled health problems that exercise could worsen.
  • Can communicate and fill out written forms in English.
  • Can understand the study and are willing to sign a consent form before any study procedures.
  • Are willing to travel to DFCI for study measurements.

Who can't join

  • Did more than 90 minutes a week of medium-to-hard aerobic exercise, such as brisk walking, over the past month.
  • Have unstable health problems that make medium-to-hard exercise unsafe.
  • Are currently following a weight-loss diet or taking weight-loss drugs.
  • Have another active cancer, except basal cell carcinoma, a type of skin cancer.
  • The study doctor thinks you may not be able to follow the study's safety checks.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Patient diagnosed with early-stage or metastatic colon or rectal cancer * Age at diagnosis 18-50 years; due to the specificity of the study question those outside the age bracket will not be included * No plans for major surgical intervention at the time of recruitment for a minimum of 12 weeks (i.e. study period; placement of port a cath is allowed) * No plans for radiation therapy at the time of recruitment for a minimum of 12 weeks * On or planning chemotherapy * Participate in less than or equal to 90 minutes of moderate-to-vigorous exercise per week * Medical clearance to perform exercise intervention and testing by their treating oncologist * No uncontrolled medical conditions that could be exacerbated with exercise * Ability to communicate and complete written forms in English * Ability to understand and the willingness to sign informed consent prior to any study-related procedures * Willing to travel to DFCI for necessary data collection Exclusion Criteria: * Participate in more than 90 minutes of moderate-to-vigorous aerobic exercise per week over the past month. This study targets insufficiently active persons to assess the effect of the described exercise intervention, where additional exercise done regularly will contaminate the intervention effects. * Unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise. Patients with unstable comorbidities may develop unexpected adverse events from exercise. For the purpose of patients' safety, as well as because this study involves remote, home-based exercise where close supervision is not possible, patients with unstable medical conditions are excluded. * Patients actively on a weigh loss diet and/or actively taking weight loss drugs. This could effect gut microbiome. * Patient with other active malignancies (excluding basal cell carcinoma). * Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.

Study sites (1)

MA