Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer
NCT ID: NCT05773144
Last Updated: 2026-01-07
Study Results
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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RECRUITING
NA
219 participants
INTERVENTIONAL
2023-06-01
2027-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Attention control
Static stretching
Progressive stretching
Static stretching of eight major muscle groups
75 min/wk aerobic exercise
Aerobic exercise at a dose of 75 minutes per week
Aerobic exercise
Moderate- to vigorous-intensity aerobic exercise
150 min/wk aerobic exercise
Aerobic exercise at a dose of 150 minutes per week
Aerobic exercise
Moderate- to vigorous-intensity aerobic exercise
225 min/wk aerobic exercise
Aerobic exercise at a dose of 225 minutes per week
Aerobic exercise
Moderate- to vigorous-intensity aerobic exercise
300 min/wk aerobic exercise
Aerobic exercise at a dose of 300 minutes per week
Aerobic exercise
Moderate- to vigorous-intensity aerobic exercise
Interventions
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Aerobic exercise
Moderate- to vigorous-intensity aerobic exercise
Progressive stretching
Static stretching of eight major muscle groups
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
AdventHealth Translational Research Institute
OTHER
Responsible Party
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Justin Brown
Senior 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
AdventHealth
Orlando, Florida, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PBRC 2022-018
Identifier Type: -
Identifier Source: org_study_id
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