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ACTION: Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer

Sponsor
Pennington Biomedical Research Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05773144
Collaborator
National Cancer Institute (NCI) (NIH)
219
Enrollment
5
Arms
49
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Aerobic exercise
  • Behavioral: Progressive stretching
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
219 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
May 1, 2027
Anticipated Study Completion Date :
May 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Sham Comparator: Attention control

Static stretching

Behavioral: Progressive stretching
Static stretching of eight major muscle groups
Experimental: 75 min/wk aerobic exercise

Aerobic exercise at a dose of 75 minutes per week

Behavioral: Aerobic exercise
Moderate- to vigorous-intensity aerobic exercise
Experimental: 150 min/wk aerobic exercise

Aerobic exercise at a dose of 150 minutes per week

Behavioral: Aerobic exercise
Moderate- to vigorous-intensity aerobic exercise
Experimental: 225 min/wk aerobic exercise

Aerobic exercise at a dose of 225 minutes per week

Behavioral: Aerobic exercise
Moderate- to vigorous-intensity aerobic exercise
Experimental: 300 min/wk aerobic exercise

Aerobic exercise at a dose of 300 minutes per week

Behavioral: Aerobic exercise
Moderate- to vigorous-intensity aerobic exercise

Outcome Measures

Primary Outcome Measures

  1. Chemotherapy Relative Dose Intensity [12- or 24-weeks]

    The ratio of the delivered dose intensity to the standard or planned dose intensity.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Age ≥18 years

  • Histologically confirmed stage II or III colon cancer

  • Completed surgical resection with curative intent

  • Plan to initiate an oxaliplatin-based chemotherapy regimen

  • 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Pennington Biomedical Research Center
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Justin C. Brown, Ph.D., Pennington Biomedical Research Center
  • Principal Investigator: Jeffrey A. Meyerhardt, M.D., M.P.H., Dana-Farber Cancer Institute
  • Principal Investigator: Bette J. Caan, Dr.P.H., Kaiser Permanente

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT05773144
Other Study ID Numbers:
  • PBRC 2022-018
  • U01CA271279
First Posted:
Mar 17, 2023
Last Update Posted:
Mar 17, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Colonic Neoplasms

Study Results

No Results Posted as of Mar 17, 2023