NCT06565052 The Impact of PReOPerative Exercise and NutritionaL Optimization on Perioperative Outcomes for Patients Undergoing Treatment for Rectal Cancer: The PROPEL Trial
| NCT ID | NCT06565052 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dana-Farber Cancer Institute |
| Condition | Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-12-15 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-12-15 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
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.
Contact & Investigator
Jeffrey Meyerhardt, MD, MPH
PRINCIPAL INVESTIGATOR
Dana-Farber Cancer Institute
Frequently Asked Questions
Who can join the NCT06565052 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06565052 currently recruiting?
Yes, NCT06565052 is actively recruiting participants. Contact the research team at jeffrey_meyerhardt@dfci.harvard.edu for enrollment information.
Where is the NCT06565052 trial being conducted?
This trial is being conducted at Boston, United States, Boston, United States.
Who is sponsoring the NCT06565052 clinical trial?
NCT06565052 is sponsored by Dana-Farber Cancer Institute. The principal investigator is Jeffrey Meyerhardt, MD, MPH at Dana-Farber Cancer Institute. The trial plans to enroll 40 participants.
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