Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05773144

Acronym

ACTION

Enrollment

219

Registered

2023-03-17

Start date

2023-06-01

Completion date

2027-05-01

Last updated

2026-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Neoplasms

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.

Interventions

BEHAVIORALAerobic exercise

Moderate- to vigorous-intensity aerobic exercise

BEHAVIORALProgressive stretching

Static stretching of eight major muscle groups

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

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

Design outcomes

Primary

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

Countries

United States

Contacts

Primary ContactJustin C. Brown, Ph.D.

Justin.Brown4@AdventHealth.com4076095000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026