Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer (ACTION)

Pennington Biomedical Research Center

Status: Enrolling

Conditions: Colonic Neoplasms

Treatments: Behavioral: Progressive stretching; Behavioral: Aerobic exercise

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05773144

U01CA271279 (U.S. NIH Grant/Contract)

PBRC 2022-018

Details and patient eligibility

About

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.

Enrollment: 219 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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219 participants in 5 patient groups

Attention control

Sham Comparator group

Description:

Static stretching

Treatment:

Behavioral: Progressive stretching

75 min/wk aerobic exercise

Experimental group

Description:

Aerobic exercise at a dose of 75 minutes per week

Treatment:

Behavioral: Aerobic exercise

150 min/wk aerobic exercise

Experimental group

Description:

Aerobic exercise at a dose of 150 minutes per week

Treatment:

Behavioral: Aerobic exercise

225 min/wk aerobic exercise

Experimental group

Description:

Aerobic exercise at a dose of 225 minutes per week

Treatment:

Behavioral: Aerobic exercise

300 min/wk aerobic exercise

Experimental group

Description:

Aerobic exercise at a dose of 300 minutes per week

Treatment:

Behavioral: Aerobic exercise