Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer

NCT ID: NCT05773144

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

219 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2027-05-01

Brief Summary

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To goal of this clinical trial is to quantify the dose-response effects of aerobic exercise training compared to attention control on chemotherapy relative dose intensity in colon cancer survivors.

Detailed Description

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Conditions

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Colonic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Attention control

Static stretching

Group Type SHAM_COMPARATOR

Progressive stretching

Intervention Type BEHAVIORAL

Static stretching of eight major muscle groups

75 min/wk aerobic exercise

Aerobic exercise at a dose of 75 minutes per week

Group Type EXPERIMENTAL

Aerobic exercise

Intervention Type BEHAVIORAL

Moderate- to vigorous-intensity aerobic exercise

150 min/wk aerobic exercise

Aerobic exercise at a dose of 150 minutes per week

Group Type EXPERIMENTAL

Aerobic exercise

Intervention Type BEHAVIORAL

Moderate- to vigorous-intensity aerobic exercise

225 min/wk aerobic exercise

Aerobic exercise at a dose of 225 minutes per week

Group Type EXPERIMENTAL

Aerobic exercise

Intervention Type BEHAVIORAL

Moderate- to vigorous-intensity aerobic exercise

300 min/wk aerobic exercise

Aerobic exercise at a dose of 300 minutes per week

Group Type EXPERIMENTAL

Aerobic exercise

Intervention Type BEHAVIORAL

Moderate- to vigorous-intensity aerobic exercise

Interventions

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Aerobic exercise

Moderate- to vigorous-intensity aerobic exercise

Intervention Type BEHAVIORAL

Progressive stretching

Static stretching of eight major muscle groups

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years
* Histologically confirmed stage II or III colon cancer
* Completed surgical resection with curative intent
* Plan to initiate chemotherapy
* Engage in \<60 minutes per week of moderate- to vigorous-intensity structured aerobic exercise
* No planned major surgery during the study period
* Readiness to exercise, as determined by a modified version of the Physical Activity Readiness Questionnaire
* Can walk 400 meters
* Can read and speak English
* Ability to provide written informed consent
* Provide written approval by qualified healthcare professional
* Willing to be randomized

Exclusion Criteria

* Evidence of metastatic colon cancer
* Concurrently actively treated other (non-colon) cancer
* Currently pregnant, breastfeeding, or planning to become pregnant within the next 24 weeks
* Currently participating in another study with competing outcomes
* Any other condition that, in the opinion of the investigator, would preclude participation or successful compliance with the protocol
* Any other situation that, in the opinion of the investigator, would negatively impact subject safety or successful compliance with the protocol
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

AdventHealth Translational Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Justin Brown

Senior Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Justin C. Brown, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

AdventHealth

Jeffrey A. Meyerhardt, M.D., M.P.H.

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Bette J. Caan, Dr.P.H.

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

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Kaiser Permanente Northern California

Oakland, California, United States

Site Status RECRUITING

AdventHealth

Orlando, Florida, United States

Site Status RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Justin C. Brown, Ph.D.

Role: CONTACT

4076095000

Facility Contacts

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Michelle Ross

Role: primary

Abigail Tice, Ph.D.

Role: primary

Christine Lu, M.P.H.

Role: primary

Other Identifiers

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U01CA271279

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PBRC 2022-018

Identifier Type: -

Identifier Source: org_study_id

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