Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer

ConditionColonic Neoplasms

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorAdventHealth Translational Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Histologically confirmed stage II or III colon cancer

Completed surgical resection with curative intent

Plan to initiate chemotherapy

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

219 Participants

are divided into 5 treatment groups

Group A: Attention controlSham comparator 1 intervention

Group B: 75 min/wk aerobic exerciseExperimental treatment 1 intervention

Group C: 150 min/wk aerobic exerciseExperimental treatment 1 intervention

Group D: 225 min/wk aerobic exerciseExperimental treatment 1 intervention

Group E: 300 min/wk aerobic exerciseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Chemotherapy Relative Dose Intensity

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

Time frame

12- or 24-weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AdventHealth Translational Research Institute

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

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