The Impact of PReOPerative Exercise and NutritionaL Optimization on Perioperative Outcomes for Patients Undergoing Treatment for Rectal Cancer: The PROPEL Trial

Not Applicable

Not yet recruiting

• Conditions: Rectal Cancer; Colorectal Cancer; Rectal Cancer Stage II; Rectal Cancer Stage III

• Registration Number: NCT06565052
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-16
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Age greater than or equal to 18 years at time of enrollment.<br><br> - English-Speaking.<br><br> - Diagnosis of clinical stage II-III rectal cancer.<br><br> - Planned, ongoing or just completed neoadjuvant treatment, including either 1)<br> chemoradiation, 2) total neoadjuvant therapy (TNT), or 3) chemotherapy only; and<br> anticipated surgical resection to follow.<br><br> - Able to understand the study procedures, agree to participate in the study program,<br> and voluntarily provide informed consent.<br><br>Exclusion Criteria:<br><br> - Distant metastatic disease known at the time of diagnosis.<br><br> - Functional incapacity (i.e., incapable of performing exercise testing).<br><br> - Comorbid conditions or cognitive/physical impairments that contraindicate exercise.<br><br> - Currently undergoing treatment for a secondary primary tumor, in addition to primary<br> rectal cancer.<br><br> - Currently enrolled in a separate clinical trial that would prohibit them from<br> performing the tasks instructed in this trial.<br><br> - Currently participating in more than 60 minutes of moderate-to-vigorous aerobic<br> exercise per week over the past month. This study targets insufficiently active<br> persons to assess the effect of the described intervention, where additional<br> exercise done regularly will contaminate the intervention effects.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Enrollment Rate