Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer

Not Applicable

Recruiting

• Conditions: Colonic Neoplasms
• Interventions: Behavioral: Aerobic exercise; Behavioral: Progressive stretching

• Registration Number: NCT05773144
• Lead Sponsor: Pennington Biomedical Research Center

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2023-03-06
• Study First Submitted QC: 2023-03-06
• Study First Posted: 2023-03-17
• Study Start: 2023-06-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-30
• Primary Completion: 2027-05
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 219

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
75 min/wk aerobic exercise	Aerobic exercise	Aerobic exercise at a dose of 75 minutes per week
300 min/wk aerobic exercise	Aerobic exercise	Aerobic exercise at a dose of 300 minutes per week
225 min/wk aerobic exercise	Aerobic exercise	Aerobic exercise at a dose of 225 minutes per week
Attention control	Progressive stretching	Static stretching
150 min/wk aerobic exercise	Aerobic exercise	Aerobic exercise at a dose of 150 minutes per week

Primary Outcome Measures

Name	Time	Method
Chemotherapy Relative Dose Intensity	12- or 24-weeks	The ratio of the delivered dose intensity to the standard or planned dose intensity.

Trial Locations

Locations (3)

Kaiser Permanente Northern California; 🇺🇸 Oakland, California, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States