Clinical Trials Logo
  1. Home
  2. Rectal Neoplasms
  3. NCT05789433
  4. Details
NCT05789433 Clinical Trial

Effects of Aerobic Exercise on Skeletal Muscle Remodeling in Colorectal Cancer

Rectal Neoplasms Clinical Trial

— RESTORE  

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
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
See also
  Status Clinical Trial Phase
Completed NCT02537340 - PET/MR for Staging Rectal Cancer Patients With and Without EMVI-MR
Recruiting NCT02565667 - A Prospective Clinical Study for Transanal Double Purse-string Rectal Anastomosis Preformed With KOL Stapler N/A
Not yet recruiting NCT02439086 - Prediction of Response to Neoadjuvant Therapy in Rectal Cancer N/A
Terminated NCT02538913 - Exercise Training for Rectal Cancer Patients N/A
Completed NCT02233374 - Predicting RadIotherapy ReSponse of Rectal Cancer With MRI and PET N/A
Completed NCT00535041 - Pilot Trial of Pre-operative Chemo/RT Using Xeloda and External Beam RT Followed by Definite Surgery in Patients With Localized Rectal CA N/A
Completed NCT00535652 - Concentration of Ertapenem in Colorectal Tissue Phase 4
Recruiting NCT04949646 - Intraoperative Neuromonitoring of Pelvic Autonomous Nerve Plexus During Total Mesorectal Excision N/A
Recruiting NCT04095468 - Organ-preserving Management in Patients With Complete or Near-complete Tumour Response After Preoperative Radio(Chemo)Therapy for Rectal Cancer
Recruiting NCT06017583 - Neoadjuvant Chemotherapy With PD-1 Inhibitors Combined With SIB-IMRT in the Treatment of Locally Advanced Rectal Cancer Phase 3
Recruiting NCT05689775 - Reconstruction After Abdominoperineal Resection With Robot-assisted Harvest of VRAM Flap
Recruiting NCT04006951 - Development of a Clinical and Biological Database in Rectum Cancer N/A
Recruiting NCT05068180 - Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients Phase 4
Recruiting NCT03714490 - MRI Simulation-guided Boost in Short-course Preoperative Radiotherapy for Unresectable Rectal Cancer Phase 2
Recruiting NCT03325361 - The Role of Transanal Tube Drainage as A Mean of Prevention of Anastomotic Leakage Anastomotic Leakage N/A
Completed NCT02252250 - Transanal Total Mesorectal Excision Versus Laparoscopic TME for Rectal Cancer N/A
Completed NCT01816607 - Functional MRI of Hypoxia-mediated Rectal Cancer Aggressiveness
Completed NCT04455737 - Ex Vivo Intra-arterial Indigo Carmine Injection After Transanal Total Mesorectal Excision
Completed NCT01721785 - Diagnostic Value of Novel MR Imaging Techniques for the Primary Staging and Restaging of Rectal Cancer N/A
Active, not recruiting NCT01171300 - Assessment of Response Before, During and After Neoadjuvant Chemoradiotherapy in Rectal Cancer Patients N/A