Could a home workout program reshape the gut and tame chemo toxicity?
NCT ID NCT06202183
First seen Aug 19, 2026 · Last updated Sep 11, 2026 · Updated 2 times
Summary
This trial tests whether a 12-week home-based exercise program can alter the gut microbiome in young adults (ages 18-50) with colorectal cancer who are undergoing chemotherapy. Participants are randomly assigned to either the exercise group or a waitlist control group. Researchers will compare changes in gut bacteria, chemotherapy side effects, and treatment outcomes between the two groups.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A 12-week home-based exercise program with aerobic and resistance training, virtually supervised, including a stationary bike, resistance bands, and a Fitbit.
- What this could lead to
- If exercise shifts the gut microbiome in a beneficial way, it could help reduce chemotherapy side effects and improve treatment outcomes for young colorectal cancer patients.
- What could go wrong
- This is a relatively small, early-stage trial, so results may not apply to all patients. The exercise program may be hard to stick with, and the impact on the microbiome and treatment outcomes is uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 84 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jul 2024
- Expected to finish
-
Jul 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 50 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Colorectal cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Dana Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02215, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a lab test tell which chemo works for colon cancer?
- Can MRI and computer models predict how well cancer drugs reach tumors?
- Gut bacteria may hold clues to why some cancer treatments work better
- Burning the edges: a new way to stop colon polyps from coming back
- Can a hyaluronic acid drug combo outperform bevacizumab in Hard-to-Treat colon cancer?
- Missed Follow-Up colonoscopies: do they raise the risk of advanced growths?