Clinical trial NCT06565052: The Impact of PReOPerative Exercise and NutritionaL Optimization on Perioperative Outcomes for Patients Undergoing Treatment for Rectal Cancer: The PROPEL Trial
Official title: The Impact of PReOPerative Exercise and NutritionaL Optimization on Perioperative Outcomes for Patients Undergoing Treatment for Rectal Cancer: The PROPEL Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rectal Cancer
Colorectal Cancer
Rectal Cancer Stage II
Rectal Cancer Stage III
Keywords: Rectal Cancer
Colorectal Cancer
Rectal Cancer Stage II
Rectal Cancer Stage III
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Enrollment Rate
timeFrame: Baseline
Secondary outcomes:
measure: Adherence Rate to the Prehabilitation Program
timeFrame: At post-intervention (approximately Week 4)
measure: Completion Rate of Physical Function Testing (Group A)
timeFrame: At post-intervention (approximately Week 4)
measure: Completion Rate of Physical Function Testing (Group B)
timeFrame: At post-intervention (approximately Week 4)
measure: Completion Rate of Questionnaire Assessments
timeFrame: At baseline and the postoperative visit (approximately Week 9)
measure: Participant Fall Rate (Group A)
timeFrame: At post-intervention (approximately Week 4)
measure: Participant Fall Rate (Group B)
timeFrame: At post-intervention (approximately Week 4)
measure: Rate of Hospitalization (Group A)
timeFrame: At post-intervention (approximately Week 4)
measure: Rate of Hospitalization (Group B)
timeFrame: At post-intervention (approximately Week 4)
measure: Rate of Musculoskeletal Injury (Group A)
timeFrame: At post-intervention (approximately Week 4)
measure: Rate of Musculoskeletal Injury (Group B)
timeFrame: At post-intervention (approximately Week 4)
measure: Change in Resting Blood Pressure from Baseline to Post-Intervention
timeFrame: From baseline to post-operative visit (approximately week 9)
measure: Change in Cardiorespiratory Fitness from Baseline to Post-Intervention
timeFrame: From baseline to post-operative visit (approximately week 9)
measure: Change in Short Physical Performance Battery (SPPB) Score from Baseline to Post-Intervention
timeFrame: From baseline to post-operative visit (approximately week 9)
measure: Change in Muscle Strength from Baseline to Post-Intervention
timeFrame: From baseline to post-operative visit (approximately week 9)
measure: Change in Height from Baseline to Post-Intervention
timeFrame: From baseline to post-operative visit (approximately week 9)
measure: Change in Weight from Baseline to Post-Intervention
timeFrame: From baseline to post-operative visit (approximately week 9)
measure: Change in Waist Circumference from Baseline to Post-Intervention
timeFrame: From baseline to post-operative visit (approximately week 9)
measure: Change in Hip Circumference from Baseline to Post-Intervention
timeFrame: From baseline to post-operative visit (approximately week 9)
measure: Change in Body Mass Index from Baseline to Post-Intervention
timeFrame: From baseline to post-operative visit (approximately week 9)
measure: Change in Nutritional Status from Baseline to Post-Surgery (Group A)
timeFrame: From baseline to postoperative visit, up to 9 weeks
measure: Change in Nutritional Status from Baseline to Post-Surgery (Group B)
timeFrame: From baseline to postoperative visit, up to 9 weeks
measure: Change in Quality of Life from Baseline to Post-Surgery (Group A)
timeFrame: From baseline to postoperative visit, up to 9 weeks
measure: Change in Quality of Life from Baseline to Post-Surgery (Group B)
timeFrame: From baseline to postoperative visit, up to 9 weeks
measure: Change in Pittsburgh Sleep Quality Index (PSQI) Score from Baseline to Post-Surgery (Group A)
timeFrame: From baseline to postoperative visit, up to 9 weeks
measure: Change in PSQI Score from Baseline to Post-Surgery (Group B)
timeFrame: From baseline to postoperative visit, up to 9 weeks
measure: Change in Clinical Frailty Scale (CFS) Score from Baseline to Post-Surgery (Group A)
timeFrame: From baseline to postoperative visit, up to 9 weeks
measure: Change in Clinical Frailty Scale (CFS) Score from Baseline to Post-Surgery (Group B)
timeFrame: From baseline to postoperative visit, up to 9 weeks
measure: Length of Hospitalization Post-Surgery (Group A)
timeFrame: 30 Days
measure: Length of Hospitalization Post-Surgery (Group B)
timeFrame: 30 Days
measure: Time To Return of Bowel Function Post-Surgery (Group A)
timeFrame: 30 Days
measure: Time To Return of Bowel Function Post-Surgery (Group B)
timeFrame: 30 Days
measure: Discharge Disposition (Group B)
timeFrame: 30 Days
measure: Discharge Disposition (Group A)
timeFrame: 30 Days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Jeffrey Meyerhardt, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: