Clinical trial · Interventional
The Impact of PReOPerative Exercise and NutritionaL Optimization on Perioperative Outcomes for Patients Undergoing Treatment for Rectal Cancer: The PROPEL Trial
NCT06565052CI-TRIAL-00097829recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Rectal Cancer Stage II | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Rectal Cancer Stage III | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prehabilitation Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A: Prehabilitation Program
- description
- Participants will be randomized in a 1:1 ratio using a permuted blocked design and stratified by neoadjuvant therapy received. Participants will complete the following: * In-clinic baseline visit with assessments * Virtual exercise sessions 3 days per week for 4 weeks. * IMN supplementation and daily multivitamin starting at 4 weeks of the preoperative phase. * Resection surgery per standard of care * In-clinic 30 day postoperative visit.
- interventionNames
- Behavioral: Prehabilitation Program
- type
- NO_INTERVENTION
- label
- Group B: Usual Care
- description
- Participants will be randomized in a 1:1 ratio using a permuted blocked design and stratified by neoadjuvant therapy received. Participants will complete the following: * In-clinic baseline visit with assessments * Resection surgery per standard of care * In-clinic 30 day postoperative visit * After completion of the study period, participants will be offered exercise equipment with an exercise instruction booklet.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.