Effects of Aerobic Exercise on Skeletal Muscle Remodeling in Colorectal Cancer (RESTORE)

AdventHealth Translational Research Institute

Status: Enrolling

Conditions: Colonic Neoplasms; Rectal Neoplasms

Treatments: Behavioral: Progressive stretching; Behavioral: Aerobic exercise

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05789433

R01CA270274 (U.S. NIH Grant/Contract)

PBRC 2022-014

Details and patient eligibility

About

The goal of this clinical trial is to quantify the effects of aerobic exercise training compared to attention control on intermuscular adipose tissue in colorectal cancer survivors.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years
• Histologically confirmed stage I, II, or III colon or rectal cancer
• Completed surgical resection with curative intent
• Completed other cancer-directed treatments
• Engage in <150 minutes per week of moderate- to vigorous-intensity structured endurance exercise
• No planned major surgery during the study period
• Readiness to exercise, as determined by a modified version of the Physical Activity Readiness Questionnaire
• Ability to provide written informed consent
• Provide written approval by a qualified healthcare professional
• Willing to be randomized

Exclusion criteria

• Evidence of metastatic or recurrent colorectal cancer
• Concurrently actively treated other (non-colorectal) cancer
• Scheduled to receive other postoperative cancer-directed treatment(s)
• Currently pregnant, breastfeeding, or planning to become pregnant within the next 24 weeks
• Currently participating in another study with competing outcomes
• Contraindications to magnetic resonance imaging
• Any dietary condition or restriction that would limit tolerance of a mixed meal challenge
• Any other cardiovascular, pulmonary, orthopedic, neurologic, psychiatric, or other condition that, in the investigator's opinion, 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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70 participants in 2 patient groups

Attention control

Sham Comparator group

Description:

Static stretching

Treatment:

Behavioral: Progressive stretching

Aerobic exercise

Experimental group

Description:

Aerobic exercise at a dose of 225 minutes per week

Treatment:

Behavioral: Aerobic exercise