Colorectal CancerNCT06202183
Exercise for Gut Microbiome in Patients With Young-Onset Colorectal Cancer Undergoing Chemotherapy: The COURAGE Trial
A study testing Exercise Program in people with Colorectal Cancer and Metastatic Colon Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Colorectal Cancer, Metastatic Colon Cancer, Metastatic Colorectal Cancer
- What is being tested?
- Exercise Program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2024to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Christina Dieli-Conwright, MPH, PhD, 617-582-8321, ChristinaM_Dieli-Conwright@dfci.harvard.edu
Christina Dieli-Conwright, MPH, PhD
About this study
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
Read the detailed description
This research study is a single-center, two-armed, 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. Participants will be randomly assigned to one of two groups: Group A: Exercise group (EXE) vs. Group B: Waitlist control group (WC). Randomization means that a participant will be placed into one of the study groups by chance.
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.
It is expected that about 84 people will take part in this research study.
The American Cancer Society is providing funding for this research study.
- Being tested
- Exercise Program
- Keywords
- Colorectal Cancer, Metastatic Colon Cancer, Metastatic Colorectal Cancer, Early Stage Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ProgramBehavioural
A 12 week, home-based, virtually supervised, aerobic and resistance exercise training program comprised of 36 sessions. Participants will be provided with a home stationary bike, resistance bands, and Fitbit. Virtually supervised sessions will be accessible via Zoom platform. For participants who do not have a device, a Wi-Fi-enabled tablet will also be provided.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Exercise Group | Experimental | 42 participants will be enrolled using a permuted blocked design with varying block size and will complete study procedures as follows:
* Baseline in-office visit.
* Completion of exercise sessions 3x weekly.
* Post-intervention in-office visit. Receives: Behavioral: Exercise Program |
| Group B: Waitlist Control Group | No intervention | 42 participants will be enrolled using a permuted blocked design with varying block size and will complete study procedures as follows: * Baseline in-office visit. * Participants will be asked to maintain baseline exercise behavior and/or usual, daily activities. * Post-intervention in-office visit. Participants will be offered to participate in the exercise program upon the completion of post-intervention assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut Microbiome Genomes
Gut Microbiome Sequencing will be conducted using the stool samples at Baseline and Post-Intervention. Gut Microbiome sequencing will be performed using DNA and RNA extraction, which will analyze microbial genomes.
Measured: Baseline (Week 1) and Post-intervention (Week 13)
Secondary outcomes (1)
Change in Chemotherapy Toxicity
To evaluate changes in chemotherapy toxicity following a exercise intervention in survivors of young-onset CRC undergoing chemotherapy.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start22 Jul 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Christina Dieli-Conwright, PhD, Dana-Farber Cancer Institute
- Investigators
- Christina Dieli-Conwright, MPH, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202183
- Sponsor's protocol ID
- 23-341
- Status last verified
- Sep 2026
- First submitted
- 2 Jan 2024
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise for Gut Microbiome in Patients With Young-Onset Colorectal Cancer Undergoing Chemotherapy: The COURAGE Trial
- ClinicalTrials.gov ID
- NCT06202183
- Acronym / sponsor ID
- 23-341
- Keywords
- Colorectal Cancer, Metastatic Colon Cancer, Metastatic Colorectal Cancer, Early Stage Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This research study is a single-center, two-armed, 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. Participants will be randomly assigned to one of two groups: Group A: Exercise group (EXE) vs. Group B: Waitlist control group (WC). Randomization means that a participant will be placed into one of the study groups by chance.
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.
It is expected that about 84 people will take part in this research study.
The American Cancer Society is providing funding for this research study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Exercise Group | Experimental | Behavioral: Exercise Program42 participants will be enrolled using a permuted blocked design with varying block size and will complete study procedures as follows: * Baseline in-office visit. * Completion of exercise sessions 3x weekly. * Post-intervention in-office visit. |
| Group B: Waitlist Control Group | No intervention | –42 participants will be enrolled using a permuted blocked design with varying block size and will complete study procedures as follows: * Baseline in-office visit. * Participants will be asked to maintain baseline exercise behavior and/or usual, daily activities. * Post-intervention in-office visit. Participants will be offered to participate in the exercise program upon the completion of post-intervention assessments. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise ProgramA 12 week, home-based, virtually supervised, aerobic and resistance exercise training program comprised of 36 sessions. Participants will be provided with a home stationary bike, resistance bands, and Fitbit. Virtually supervised sessions will be accessible via Zoom platform. For participants who do not have a device, a Wi-Fi-enabled tablet will also be provided. | Behavioural | Group A: Exercise Group |
Primary outcome
Gut Microbiome Genomes
Time frame: Baseline (Week 1) and Post-intervention (Week 13)
Gut Microbiome Sequencing will be conducted using the stool samples at Baseline and Post-Intervention. Gut Microbiome sequencing will be performed using DNA and RNA extraction, which will analyze microbial genomes.
1 secondary outcome
Change in Chemotherapy Toxicity
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christina Dieli-Conwright, MPH, PhD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Program in people with Colorectal Cancer and Metastatic Colon Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina Dieli-Conwright, MPH, PhD (617-582-8321, ChristinaM_Dieli-Conwright@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut Microbiome Genomes (time frame: Baseline (Week 1) and Post-intervention (Week 13)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.