The Impact of PReOPerative Exercise and NutritionaL Optimization on Perioperative Outcomes for Pa… (NCT06565052) | Clinical Trial Compass
RecruitingNot Applicable
The Impact of PReOPerative Exercise and NutritionaL Optimization on Perioperative Outcomes for Patients Undergoing Treatment for Rectal Cancer: The PROPEL Trial
United States40 participantsStarted 2024-12-15
Plain-language summary
The purpose of this study is to determine the feasibility of a prehabilitation program for participants diagnosed with rectal cancer undergoing neoadjuvant chemotherapy and/or radiation, followed by surgical resection.
The names of the groups in this research study are:
* Group A: Prehabilitation program
* Group B: Usual Care
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Age greater than or equal to 18 years at time of enrollment.
* English-Speaking.
* Diagnosis of clinical stage II-III rectal cancer.
* Planned, ongoing or just completed neoadjuvant treatment, including either 1) chemoradiation, 2) total neoadjuvant therapy (TNT), or 3) chemotherapy only; and anticipated surgical resection to follow.
* Able to understand the study procedures, agree to participate in the study program, and voluntarily provide informed consent.
Exclusion Criteria:
* Distant metastatic disease known at the time of diagnosis.
* Functional incapacity (i.e., incapable of performing exercise testing).
* Comorbid conditions or cognitive/physical impairments that contraindicate exercise.
* Currently undergoing treatment for a secondary primary tumor, in addition to primary rectal cancer.
* Currently enrolled in a separate clinical trial that would prohibit them from performing the tasks instructed in this trial.
* Currently participating in more than 60 minutes of moderate-to-vigorous aerobic exercise per week over the past month. This study targets insufficiently active persons to assess the effect of the described intervention, where additional exercise done regularly will contaminate the intervention effects.