Effects of Aerobic Exercise on Skeletal Muscle Remodeling in Colorectal Cancer

Rectal Neoplasms Clinical Trial

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Official title:

Effects of Aerobic Exercise on Skeletal Muscle Remodeling in Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05789433
• Other study ID #: PBRC 2022-014
• Secondary ID: R01CA270274
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: March 2027

Study information

• Verified date: June 2024
• Source: Pennington Biomedical Research Center
• Contact: Justin C. Brown, Ph.D.
• Phone: 225-763-2715
• Email: justin.brown[@]pbrc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: March 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Neoplasms
• Neoplasms
• Rectal Neoplasms

Intervention

Behavioral:
• Aerobic exercise
Moderate- to vigorous-intensity aerobic exercise
• Progressive stretching
Statistic stretching of eight major muscle groups

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whole-Body Intermuscular Adipose Tissue	Mean (kg) whole-body intermuscular adipose tissue quantified using magnetic resonance imaging.	up to Week 12