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

Registration Number
NCT06565052
Lead Sponsor
Dana-Farber Cancer Institute
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.
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Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
40
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.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group A: Prehabilitation ProgramPrehabilitation ProgramParticipants 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.
Primary Outcome Measures
NameTimeMethod
Enrollment RateBaseline

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 Outcome Measures
NameTimeMethod
Participant Fall Rate (Group A)At post-intervention (approximately Week 4)

Defined as the number of falls attributable to the exercise and nutrition components of the intervention.

Participant Fall Rate (Group B)At post-intervention (approximately Week 4)

Defined as the number of falls attributable to the exercise and nutrition components of the intervention.

Change in Hip Circumference from Baseline to Post-InterventionFrom baseline to post-operative visit (approximately week 9)

Hip circumference will be measured, rounding up to the nearest 0.1cm.

Change in Clinical Frailty Scale (CFS) Score from Baseline to Post-Surgery (Group A)From baseline to postoperative visit, up to 9 weeks

Assessed by the Clinical Frailty Scale (CFS), which consists of 9 questions assessing specific domains including comorbidity, function, and cognition to generate a frailty score ranging from 1 (very fit) to 9 (terminally ill).

Length of Hospitalization Post-Surgery (Group A)30 Days

Defined as the number of days of hospitalization post-surgery.

Completion Rate of Physical Function Testing (Group A)At post-intervention (approximately Week 4)

Defined as the number of testing assessments (resting blood pressure, measure of cardiorespiratory fitness, Short Physical Performance Battery, muscular strength, and anthropometric measures) completed by participants.

Completion Rate of Physical Function Testing (Group B)At post-intervention (approximately Week 4)

Defined as the number of testing assessments (resting blood pressure, measure of cardiorespiratory fitness, Short Physical Performance Battery, muscular strength, and anthropometric measures) completed by participants.

Completion Rate of Questionnaire AssessmentsAt baseline and the postoperative visit (approximately Week 9)

Defined as the number of questionnaires completed by all participants.

Rate of Hospitalization (Group B)At post-intervention (approximately Week 4)

Defined as the number of hospitalizations attributable to the exercise and nutrition components of the intervention.

Rate of Musculoskeletal Injury (Group B)At post-intervention (approximately Week 4)

Defined as the number of musculoskeletal injuries attributable to the exercise and nutrition components of the intervention.

Change in Resting Blood Pressure from Baseline to Post-InterventionFrom baseline to post-operative visit (approximately week 9)

Assessed by resting blood pressure. The average systolic blood pressure (of two measurements from each arm) will be recorded.

Change in Height from Baseline to Post-InterventionFrom baseline to post-operative visit (approximately week 9)

Height will be measured using a stadiometer, rounding up to the nearest 0.1 cm

Change in Weight from Baseline to Post-InterventionFrom baseline to post-operative visit (approximately week 9)

Assessed by weight, rounding up to the nearest 0.1 kg.

Change in Pittsburgh Sleep Quality Index (PSQI) Score from Baseline to Post-Surgery (Group A)From baseline to postoperative visit, up to 9 weeks

Assessed by the Pittsburgh Sleep Quality Index (PSQI), a 19 question measure of 7 domains of sleep quality and patterns of sleep. The 19 self-rated items are combined to form 7 component scores, each of which has a range of 0 to 3 points with a 0 indicating no difficulty and 3 indicating severe difficulty. The 7 component scores are added to yield a total sc...

Length of Hospitalization Post-Surgery (Group B)30 Days

Defined as the number of days of hospitalization post-surgery.

Discharge Disposition (Group B)30 Days

Defined as participant disposition post-surgery: discharge to home, inpatient rehabilitation facility, or other. Data will be summarized using descriptive statistics.

Discharge Disposition (Group A)30 Days

Defined as participant disposition post-surgery: discharge to home, inpatient rehabilitation facility, or other. Data will be summarized using descriptive statistics.

Adherence Rate to the Prehabilitation ProgramAt post-intervention (approximately Week 4)

The number of intervention assessments completed by participants in Group A. Feasibility of the intervention is defined as at least 50% of participants adhering to at least 50% of the prescribed assessments of the prehabilitation program.

Change in Short Physical Performance Battery (SPPB) Score from Baseline to Post-InterventionFrom baseline to post-operative visit (approximately week 9)

Assessed by the Short Physical Performance Battery (SPPB) which is comprised of three sections: 1) balance with feet together, semi tandem, and full tandem is held for up to 10 seconds with no support and measure in seconds. Scores are summed for the measure of balance for a range of 0 to 30 seconds; 2) usual gait speed over four meters is timed (seconds); a...

Change in Waist Circumference from Baseline to Post-InterventionFrom baseline to post-operative visit (approximately week 9)

Waist circumference will be measured, rounding up to the nearest 0.1cm.

Change in Body Mass Index from Baseline to Post-InterventionFrom baseline to post-operative visit (approximately week 9)

Body composition will be assessed via bioelectrical impedance using a validated device. The device will estimate body fat using an algorithm based on participant age, sex, height, and body weight.

Change in Nutritional Status from Baseline to Post-Surgery (Group A)From baseline to postoperative visit, up to 9 weeks

Assessed by the Perioperative Nutrition Score (PONS), a validated screening questionnaire that assists in determining risk of malnutrition in the perioperative setting. This is assessed via 1) Body mass index (BMI), which can be calculated through the participant's anthropomorphic measurements, 2) self-reported unplanned changes in weight or decrease in diet...

Change in Nutritional Status from Baseline to Post-Surgery (Group B)From baseline to postoperative visit, up to 9 weeks

Assessed by the Perioperative Nutrition Score (PONS), a validated screening questionnaire that assists in determining risk of malnutrition in the perioperative setting. This is assessed via 1) Body mass index (BMI), which can be calculated through the participant's anthropomorphic measurements, 2) self-reported unplanned changes in weight or decrease in diet...

Change in Quality of Life from Baseline to Post-Surgery (Group A)From baseline to postoperative visit, up to 9 weeks

Assessed by the European Organization for Research and Treatment of Cancer's (EORTC's) Quality of Life (QOL) core questionnaire (QLQ C-30), a validated, 30-item instrument designed to quantify and measure QOL in cancer participants. Questions are rated on a four point scale from 1 "Not at all" to 4 "Very much. All items have a score range from 0 to 100 point...

Change in PSQI Score from Baseline to Post-Surgery (Group B)From baseline to postoperative visit, up to 9 weeks

Assessed by the Pittsburgh Sleep Quality Index (PSQI), a 19 question measure of 7 domains of sleep quality and patterns of sleep. The 19 self-rated items are combined to form 7 component scores, each of which has a range of 0 to 3 points with a 0 indicating no difficulty and 3 indicating severe difficulty. The 7 component scores are added to yield a total sc...

Rate of Hospitalization (Group A)At post-intervention (approximately Week 4)

Defined as the number of hospitalizations attributable to the exercise and nutrition components of the intervention.

Rate of Musculoskeletal Injury (Group A)At post-intervention (approximately Week 4)

Defined as the number of musculoskeletal injuries attributable to the exercise and nutrition components of the intervention.

Change in Cardiorespiratory Fitness from Baseline to Post-InterventionFrom baseline to post-operative visit (approximately week 9)

Assessed by VO2peak by a graded maximal (or submaximal if equipment is unavailable) cycle exercise stress test. VO2peak is defined as the highest values of oxygen uptake averaged among every 30-second interval during the test. VO2peak will be reported in both relative (ml·kg-1·min-1) and absolute (L/min) terms.

Change in Muscle Strength from Baseline to Post-InterventionFrom baseline to post-operative visit (approximately week 9)

The 1RM (repetition maximum) will be estimated from 10RM muscle strength tests on two exercises: 1) leg press, 2) chest press. 1RM values will be calculated and reported using validated equations.

Change in Quality of Life from Baseline to Post-Surgery (Group B)From baseline to postoperative visit, up to 9 weeks

Assessed by the Pittsburgh Sleep Quality Index (PSQI), a 19 question measure of 7 domains of sleep quality and patterns of sleep. The 19 self-rated items are combined to form 7 component scores, each of which has a range of 0 to 3 points with a 0 indicating no difficulty and 3 indicating severe difficulty. The 7 component scores are added to yield a total sc...

Change in Clinical Frailty Scale (CFS) Score from Baseline to Post-Surgery (Group B)From baseline to postoperative visit, up to 9 weeks

Assessed by the Clinical Frailty Scale (CFS), which consists of 9 questions assessing specific domains including comorbidity, function, and cognition to generate a frailty score ranging from 1 (very fit) to 9 (terminally ill).

Time To Return of Bowel Function Post-Surgery (Group A)30 Days

Defined as the number of days to a return of bowl function post-surgery.

Time To Return of Bowel Function Post-Surgery (Group B)30 Days

Defined as the number of days to a return of bowl function post-surgery.

Trial Locations

Locations (2)

Brigham and Women's Hospital

🇺🇸

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

🇺🇸

Boston, Massachusetts, United States

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