Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer

Part of paid clinical trials in Oakland, California.

Sponsor
AdventHealth Translational Research Institute
Study ID
NCT05773144
Status
Recruiting

Conditions

  • Colonic Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aerobic exercise — BEHAVIORAL
    Moderate- to vigorous-intensity aerobic exercise
  • Progressive stretching — BEHAVIORAL
    Static stretching of eight major muscle groups

Study Details

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.

Key Dates

Start date
Jun 1, 2023
Status verified
Jan 2026
Primary completion
May 1, 2027
Completion
May 1, 2027

Study Design

Enrollment
219 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Sham Comparator: Attention control
    Static stretching
  • Experimental: 75 min/wk aerobic exercise
    Aerobic exercise at a dose of 75 minutes per week
  • Experimental: 150 min/wk aerobic exercise
    Aerobic exercise at a dose of 150 minutes per week
  • Experimental: 225 min/wk aerobic exercise
    Aerobic exercise at a dose of 225 minutes per week
  • Experimental: 300 min/wk aerobic exercise
    Aerobic exercise at a dose of 300 minutes per week

Primary Outcome Measure

Chemotherapy Relative Dose Intensity [ Time Frame: 12- or 24-weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Kaiser Permanente Northern CaliforniaOaklandCalifornia94612
Michelle Ross
Bette J Caan, Dr.P.H. (PRINCIPAL_INVESTIGATOR)
AdventHealthOrlandoFlorida32804
Abigail Tice, Ph.D.
Justin Brown, Ph.D. (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Christine Lu, M.P.H.
Jeffrey A Meyerhardt, M.D. (PRINCIPAL_INVESTIGATOR)

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