Stage II Colorectal Cancer AJCC v8NCT05930496

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

A study testing Biospecimen Collection, Exercise Intervention and Health Education in people with Stage II Colorectal Cancer AJCC v8 and Stage III Colorectal Cancer AJCC v8, run by Fred Hutchinson Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Stage II Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8, Colorectal Carcinoma
What is being tested?: Biospecimen Collection, Exercise Intervention and Health Education
Type of treatment: Surgery or procedure, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 8 Jul 2025to 30 Jun 2026
Phase: Interventional
Are there results?: None posted in the registry

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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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) 18.5-35 kg/m^2

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Able to understand and willing to sign written informed consent in English
Access to phone for study contacts
Access to a smart phone or tablet to connect to the Polar H10 Heart rate sensor during remote exercise sessions and attend virtual exercise sessions
Be willing and able to attend up to 24 sessions in-person at the Fred Hutch Exercise Research Center Shared Resource or virtually via phone, Zoom, or Microsoft Teams, based on participant preference
Access to internet (internet access may be provided on a case-by-case basis to participants where access to internet would otherwise be the only barrier to participation)
Willingness to participate in all study activities
Completion of all run-in activities
Participants must have an Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status score of 0 or 1 for performance status
Women must not be pregnant, breastfeeding, or planning to become pregnant

Who cannot join

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 class II/III obesity (BMI ≥ 35.0 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
Women who are pregnant, breastfeeding, or planning to become pregnant
Physician notification to not approach patient for the study

Trial locations and contacts

1 site in 1 country.

United States1 site

Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109

Other trials in United States

About this study

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

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.

Read the detailed description

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive the supervised exercise intervention (in-person or virtual) three times weekly (TID) 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 an in-person session of supervised exercise followed by weekly virtual tele-coaching sessions for 7 weeks. Patients also undergo collection of blood samples on study.

Conditions: Stage II Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8, Colorectal Carcinoma
Being tested: Biospecimen Collection, Exercise Intervention, Health Education, Interview, Questionnaire Administration
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo collection of blood samples
Exercise InterventionOther
Receive exercise intervention
Exercise InterventionOther
Receive tele-coaching intervention
Health EducationBehavioural
Receive health-related information
InterviewOther
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies

Study groups in NCT05930496
Study group	Role	What they receive
Arm A (exercise intervention)	Experimental	Patients receive the supervised exercise intervention (in-person or virtual) TID over 8 weeks on study. Patients also undergo collection of blood samples on study. Receives: Procedure: Biospecimen Collection; Other: Exercise Intervention; Other: Interview; Other: Questionnaire Administration
Arm B (waitlist control)	Active comparator	Patients receive health-related information for 8 weeks on study. Patients are then offered an in-person session of supervised exercise followed by weekly virtual tele-coaching sessions for 7 weeks. Patients also undergo collection of blood samples on study. Receives: Procedure: Biospecimen Collection; Other: Exercise Intervention; Behavioral: Health Education; Other: Interview; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

Recruitment
Recruitment (accrual rate) will be assessed to determine feasibility. Will be summarized using descriptive statistics.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 8 weeks

Secondary outcomes (2)

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.
Measured: 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.
Measured: At 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jul 202530 Jun 2026

First posted5 Jul 2023
Study start8 Jul 2025
Primary completion30 Jun 2026
Study completion30 Jun 2026

Why it stopped: Terminated due to low accrual.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Stage II Colorectal Cancer AJCC v8Studies of the same condition, open and under way.
More trials run by Fred Hutchinson Cancer CenterThe 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: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05930496
Sponsor's protocol ID: RG1123467
Other IDs: NCI-2023-03747, P30CA015704, 20059
Status last verified: Aug 2026
First submitted: 26 Jun 2023
Last updated: 2 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05930496
Acronym / sponsor ID: RG1123467
Conditions: Stage II Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8, Colorectal Carcinoma
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated due to low accrual.
Enrolment: 10 participants (actual)
Lead sponsor: Fred Hutchinson Cancer CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 8 Jul 2025 (actual)
Primary completion: 30 Jun 2026 (actual)
Study completion: 30 Jun 2026 (actual)
First posted: 5 Jul 2023 (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.

Detailed description

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive the supervised exercise intervention (in-person or virtual) three times weekly (TID) over 8 weeks on study. Patients also undergo collection of blood samples on study.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm A (exercise intervention)	Experimental	Procedure: Biospecimen Collection, Other: Exercise Intervention, Other: Interview, Other: Questionnaire AdministrationPatients receive the supervised exercise intervention (in-person or virtual) TID over 8 weeks on study. Patients also undergo collection of blood samples on study.
Arm B (waitlist control)	Active comparator	Procedure: Biospecimen Collection, Other: Exercise Intervention, Behavioral: Health Education, Other: Interview, Other: Questionnaire AdministrationPatients receive health-related information for 8 weeks on study. Patients are then offered an in-person session of supervised exercise followed by weekly virtual tele-coaching sessions for 7 weeks. Patients also undergo collection of blood samples on study.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

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)

Key exclusion criteria (6 listed)

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 class II/III obesity (BMI ≥ 35.0 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
Women who are pregnant, breastfeeding, or planning to become pregnant

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
Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo collection of blood samples	Procedure or surgery	Arm A (exercise intervention), Arm B (waitlist control)
Exercise InterventionReceive exercise intervention	Other	Arm A (exercise intervention)
Exercise InterventionReceive tele-coaching intervention	Other	Arm B (waitlist control)
Health EducationReceive health-related information	Behavioural	Arm B (waitlist control)
InterviewAncillary studies	Other	Arm A (exercise intervention), Arm B (waitlist control)
Questionnaire AdministrationAncillary studies	Other	Arm A (exercise intervention), Arm B (waitlist control)

Primary outcome

Recruitment
Time frame: Up to 8 weeks
Recruitment (accrual rate) will be assessed to determine feasibility. Will be summarized using descriptive statistics.
Adherence
Time frame: Up to 8 weeks
Adherence will be measured by session attendance in the intervention arm to determine feasibility. Will be summarized using descriptive statistics.
Retention
Time frame: Up to 8 weeks
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
Time frame: Up to 8 weeks
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.

2 secondary outcomes

Effects of an 8 week supervised exercise intervention on fecal concentrations of butyrate
Time frame: At 8 weeks
Effects of an 8 week supervised exercise intervention on fecal concentrations of other short chain fatty acids
Time frame: At 8 weeks

Results and safety

The study was stopped early (reason given: Terminated due to low accrual.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
Individual participant dataSharing planned: No

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RecruitingPhase 2
Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, ERASur Trial
Metastatic Colorectal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v8
Recruiting
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Active, not recruitingPhase 3
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Active, not recruitingPhase 2
Testing Nivolumab and Ipilimumab With Short-Course Radiation in Locally Advanced Rectal Cancer
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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. This study is not recruiting at the moment.

Heather Greenlee principal investigator

Fred Hutch/University of Washington Cancer Consortium

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 15 inclusion and 6 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: stopped early, as of the sponsor's last update on 2 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?

The study was stopped early (reason given: Terminated due to low accrual.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment (time frame: Up to 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05930496.

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 2 Sep 2026.