Recruiting

Exercise & Waitlist Control

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT06202183

Conditions

Colorectal Cancer

Metastatic Colon Cancer

Metastatic Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Exercise Program

Study Details

Brief 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.

The names of the study groups involved in this study are:

  • Exercise
  • Waitlist Control

Conditions

Colorectal Cancer

Metastatic Colon Cancer

Metastatic Colorectal Cancer

Study ID

NCT06202183

Start date

Jul 22, 2024

Status verified date

Aug, 2025

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

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 Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Group A: Exercise Group

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.

no intervention: Group B: Waitlist Control Group

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.

Interventions

Exercise Program

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.

Primary outcome measure

  • Gut Microbiome Genomes [ Time Frame: Baseline (Week 1) and Post-intervention (Week 13) ]

Central Contacts and Locations

Central contacts

Christina Dieli-Conwright, MPH, PhD

617-582-8321ChristinaM_Dieli-Conwright@dfci.harvard.edu

Locations

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Christina Dieli-Conwright, MPH, PhD

617-582-8321ChristinaM_Dieli-Conwright@dfci.harvard.edu

Principal Investigator:

Christina Dieli-Conwright, MPH, PhD

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Aug 19, 2026

Last verified

Aug, 2025

Keywords

  • Colorectal Cancer
  • Metastatic Colon Cancer
  • Metastatic Colorectal Cancer
  • Early Stage Colorectal Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-08-19.