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

Primary Purpose

Colonic Neoplasms, Rectal Neoplasms

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic exercise
Progressive stretching
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colonic Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Pennington Biomedical Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Attention control

Aerobic exercise

Arm Description

Static stretching

Aerobic exercise at a dose of 225 minutes per week

Outcomes

Primary Outcome Measures

Whole-Body Intermuscular Adipose Tissue
Mean (kg) whole-body intermuscular adipose tissue quantified using magnetic resonance imaging.

Secondary Outcome Measures

Full Information

First Posted
March 16, 2023
Last Updated
May 29, 2023
Sponsor
Pennington Biomedical Research Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05789433
Brief Title
Effects of Aerobic Exercise on Skeletal Muscle Remodeling in Colorectal Cancer
Acronym
RESTORE
Official Title
Effects of Aerobic Exercise on Skeletal Muscle Remodeling in Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
March 2027 (Anticipated)
Study Completion Date
March 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms, Rectal Neoplasms

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Attention control
Arm Type
Sham Comparator
Arm Description
Static stretching
Arm Title
Aerobic exercise
Arm Type
Experimental
Arm Description
Aerobic exercise at a dose of 225 minutes per week
Intervention Type
Behavioral
Intervention Name(s)
Aerobic exercise
Intervention Description
Moderate- to vigorous-intensity aerobic exercise
Intervention Type
Behavioral
Intervention Name(s)
Progressive stretching
Intervention Description
Statistic stretching of eight major muscle groups
Primary Outcome Measure Information:
Title
Whole-Body Intermuscular Adipose Tissue
Description
Mean (kg) whole-body intermuscular adipose tissue quantified using magnetic resonance imaging.
Time Frame
up to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Justin C. Brown, Ph.D.
Phone
225-763-2715
Email
justin.brown@pbrc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin C. Brown, Ph.D.
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin C Brown, Ph.D.

12. IPD Sharing Statement

Learn more about this trial

Effects of Aerobic Exercise on Skeletal Muscle Remodeling in Colorectal Cancer

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