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

Dana-Farber Cancer Institute2 sites in 1 country40 target enrollmentDecember 15, 2024

ConditionsRectal Cancer Colorectal Cancer Rectal Cancer Stage II Rectal Cancer Stage III

Overview

Phase: N/A
Intervention: Not specified
Conditions: Rectal Cancer
Sponsor: Dana-Farber Cancer Institute
Enrollment: 40
Locations: 2
Primary Endpoint: Enrollment Rate
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Detailed Description

This is a non-blinded, randomized control trial to determine the feasibility of a hybrid-model, prehabilitation program for participants diagnosed with rectal cancer undergoing neoadjuvant therapy (chemotherapy and/or radiation) before surgical resection. Investigators hope that prehabilitation will result in improved outcomes after surgery. Participants will be randomized into one of the study groups: Group A: prehabilitation program, or Group B: usual care. Randomization means that a participant is placed into a group by chance. The research study procedures include screening for eligibility, in-clinic visits, physical exams, exercise training, blood tests, and questionnaires. It is expected that about 40 participants will take part in this research study.

Registry

clinicaltrials.gov

Start Date

December 15, 2024

End Date

August 7, 2027

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Dana-Farber Cancer Institute

Responsible Party

Principal Investigator

Jeffrey A. Meyerhardt, MD

Principal Investigator

Dana-Farber Cancer Institute

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.

Outcomes

Primary Outcomes

Enrollment Rate

Time Frame: Baseline

The proportion of eligible individuals that are enrolled to the study. Feasibility of the intervention is defined as an enrollment rate of greater than 10% of approached, eligible participants.

Secondary Outcomes

Participant Fall Rate (Group A)(At post-intervention (approximately Week 4))
Participant Fall Rate (Group B)(At post-intervention (approximately Week 4))
Change in Hip Circumference from Baseline to Post-Intervention(From baseline to post-operative visit (approximately week 9))
Change in Clinical Frailty Scale (CFS) Score from Baseline to Post-Surgery (Group A)(From baseline to postoperative visit, up to 9 weeks)
Length of Hospitalization Post-Surgery (Group A)(30 Days)
Completion Rate of Physical Function Testing (Group A)(At post-intervention (approximately Week 4))
Completion Rate of Physical Function Testing (Group B)(At post-intervention (approximately Week 4))
Completion Rate of Questionnaire Assessments(At baseline and the postoperative visit (approximately Week 9))
Rate of Hospitalization (Group B)(At post-intervention (approximately Week 4))
Rate of Musculoskeletal Injury (Group B)(At post-intervention (approximately Week 4))
Change in Resting Blood Pressure from Baseline to Post-Intervention(From baseline to post-operative visit (approximately week 9))
Change in Height from Baseline to Post-Intervention(From baseline to post-operative visit (approximately week 9))
Change in Weight from Baseline to Post-Intervention(From baseline to post-operative visit (approximately week 9))
Change in Pittsburgh Sleep Quality Index (PSQI) Score from Baseline to Post-Surgery (Group A)(From baseline to postoperative visit, up to 9 weeks)
Length of Hospitalization Post-Surgery (Group B)(30 Days)
Discharge Disposition (Group B)(30 Days)
Discharge Disposition (Group A)(30 Days)
Adherence Rate to the Prehabilitation Program(At post-intervention (approximately Week 4))
Change in Short Physical Performance Battery (SPPB) Score from Baseline to Post-Intervention(From baseline to post-operative visit (approximately week 9))
Change in Waist Circumference from Baseline to Post-Intervention(From baseline to post-operative visit (approximately week 9))
Change in Body Mass Index from Baseline to Post-Intervention(From baseline to post-operative visit (approximately week 9))
Change in Nutritional Status from Baseline to Post-Surgery (Group A)(From baseline to postoperative visit, up to 9 weeks)
Change in Nutritional Status from Baseline to Post-Surgery (Group B)(From baseline to postoperative visit, up to 9 weeks)
Change in Quality of Life from Baseline to Post-Surgery (Group A)(From baseline to postoperative visit, up to 9 weeks)
Change in PSQI Score from Baseline to Post-Surgery (Group B)(From baseline to postoperative visit, up to 9 weeks)
Rate of Hospitalization (Group A)(At post-intervention (approximately Week 4))
Rate of Musculoskeletal Injury (Group A)(At post-intervention (approximately Week 4))
Change in Cardiorespiratory Fitness from Baseline to Post-Intervention(From baseline to post-operative visit (approximately week 9))
Change in Muscle Strength from Baseline to Post-Intervention(From baseline to post-operative visit (approximately week 9))
Change in Quality of Life from Baseline to Post-Surgery (Group B)(From baseline to postoperative visit, up to 9 weeks)
Change in Clinical Frailty Scale (CFS) Score from Baseline to Post-Surgery (Group B)(From baseline to postoperative visit, up to 9 weeks)
Time To Return of Bowel Function Post-Surgery (Group A)(30 Days)
Time To Return of Bowel Function Post-Surgery (Group B)(30 Days)