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

Sponsor

Pennington Biomedical Research Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05789433

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Colonic Neoplasms Rectal Neoplasms	Behavioral: Aerobic exercise Behavioral: Progressive stretching	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Effects of Aerobic Exercise on Skeletal Muscle Remodeling in Colorectal Cancer

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2027

Anticipated Study Completion Date :

Mar 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Attention control Static stretching	Behavioral: Progressive stretching Statistic stretching of eight major muscle groups
Experimental: Aerobic exercise Aerobic exercise at a dose of 225 minutes per week	Behavioral: Aerobic exercise Moderate- to vigorous-intensity aerobic exercise

Arm

Intervention/Treatment

Sham Comparator: Attention control

Static stretching

Behavioral: Progressive stretching

Statistic stretching of eight major muscle groups

Experimental: Aerobic exercise

Aerobic exercise at a dose of 225 minutes per week

Behavioral: Aerobic exercise

Moderate- to vigorous-intensity aerobic exercise

Outcome Measures

Primary Outcome Measures

Whole-Body Intermuscular Adipose Tissue [up to Week 12]
Mean (kg) whole-body intermuscular adipose tissue quantified using magnetic resonance imaging.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Pennington Biomedical Research Center
National Cancer Institute (NCI)

Investigators

Principal Investigator: Justin C. Brown, Ph.D., Pennington Biomedical Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Justin Brown, Director, Cancer Metabolism Program, Pennington Biomedical Research Center

ClinicalTrials.gov Identifier:

NCT05789433

Other Study ID Numbers:

PBRC 2022-014
R01CA270274

First Posted:

Mar 29, 2023

Last Update Posted:

Apr 4, 2023

Last Verified:

Apr 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Rectal Neoplasms

Colonic Neoplasms

Study Results

No Results Posted as of Apr 4, 2023