Exercise and Nutrition to Improve Pancreatic Cancer Outcomes

Study Overview
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Brief Summary
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This is a blinded pilot study in which patients scheduled for pancreaticoduodenectomy for pancreatic or related cancers are randomized to dietary counseling and home exercise at high weekly frequency, either with or without individualized resistance training, in order to determine if such an intervention and research design are feasible in this population. We also aim to determine if physical function or quality of life can be improved with only 2-3 weeks of prehabilitation. This is in preparation for a larger study to determine if resistance improves outcomes.

Detailed Description
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This initial feasibility and proof of concept study focuses on maximizing pancreatic cancer survivors' fitness and physical function in a brief period, the 2-3 weeks available prior to surgical resection, using a home-based exercise program with all equipment provided, and following nutritional recommendations. Intervention begins when the oncologist determines that the patient is a candidate for pancreaticoduodenectomy, and continues until surgery. Participants in both arms are asked to perform moderate exercise daily, targeting a total of 60 minutes per day by the surgery date, but in bouts as short as a few minutes each, and progressed according to tolerance. Initial prescription is individualized according to the patient's baseline level of exercise and functional status. Patients record their exercise and wear an accelerometer to track activity if willing. All participants receive follow-up phone calls from an exercise specialist for adherence and assistance with progression. The intervention period ends at the time of surgery. In this 'quasi-double blinded' randomized trial, participants are not told the difference between the two exercise interventions, and randomization to the two treatment arms is stratified by baseline functional status, such that patients deemed to be 'borderline' in fitness for surgery are distributed across the groups. Prior chemotherapy exposure is allowed and recorded.

Official Title
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Preoperative Exercise and Nutrition to Improve Pancreatic Cancer Outcomes by Targeting Sarcopenia: A Translational Pilot RCT

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Behavioral: Nutritional Counseling
* Behavioral: Standard Exercise
* Behavioral: Enhanced Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion: Individuals with suspected pancreatic or related tumor for surgical resection by pancreaticoduodenectomy, including those who've received neoadjuvant chemotherapy, are eligible provided they are approved for exercise participation by pancreatic clinic team. Cognition and English language skills must be sufficient for completion of consent and questionnaires. Age >30. Able to rise from a chair and walk household distances without assist from another person. Willing to be randomized to one of two pre-operative home-based exercise programs, without knowing the difference between the two, and use protein supplementation if instructed. Exclusion: Individuals are excluded if they are unsafe (according to the study team) based on current MD recommendation not to exercise, medical history, recent fracture or high-risk bone lesion, or neurologic disorder with safety concerns. Participants cannot have an allergy to whey protein, or abnormal response to baseline physical performance tests of walking endurance and strength. Those who currently participate in a regular and substantial (as defined by the study team) strengthening or protein supplementation program are eligible only for the 'for assessment only' observational version of the study, but will not be included in the randomized trial.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard Exercise Group<br>Patients receive a single instruction session with a physical therapist, for training in moderate intensity (using Rate of Perceived Exertion) exercise including cardiovascular endurance, flexibility, and AROM of upper and lower body. If no other preferred mode of endurance training, a home ergometer is provided for use with arms and/or legs. | Behavioral: Nutritional Counseling<br>* Patients in both arms receive a single counseling session with a licensed dietician to determine individual protein goal for body weight and current dietary intake. Goal is then met through protein supplementation (provided) if needed beyond dietary intake.<br>Behavioral: Standard Exercise<br>* Patients receive a single instruction session with a physical therapist, for training in moderate intensity (using Rate of Perceived Exertion) exercise including cardiovascular endurance, flexibility, and AROM of upper and lower body. If no other preferred mode of endurance training, a home ergometer is provided for use with arms and/or legs.<br>|
| Experimental: Enhanced Exercise Group<br>Patients receive a single instruction session with a physical therapist, for training in moderate intensity (using Rate of Perceived Exertion) exercise including cardiovascular endurance, flexibility, and resistance exercise for upper and lower body. If no other preferred mode of endurance training, a home ergometer is provided for use with arms and/or legs. | Behavioral: Nutritional Counseling<br>* Patients in both arms receive a single counseling session with a licensed dietician to determine individual protein goal for body weight and current dietary intake. Goal is then met through protein supplementation (provided) if needed beyond dietary intake.<br>Behavioral: Enhanced Exercise<br>* Patients receive a single instruction session with a physical therapist, for training in moderate intensity (using Rate of Perceived Exertion) exercise including cardiovascular endurance, flexibility, and resistance exercise for upper and lower body. If no other preferred mode of endurance training, a home ergometer is provided for use with arms and/or legs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accrual | The percentage of eligible patients enrolled | 2 year | 
| Retention | Retention as the percentage of enrolled patients retained assessment point | 2 year | 
| Adherence | Adherence will be estimated as percentage of prescribed exercise completed based on exercise diaries and phone calls | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Assessment | Quality of life will be assessed using Functional Assessment of Cancer Therapy General Scale (FACT-G) during the pre-operative period (V1-V2). Scale is 0-108. The higher the score, the better the score. | Approximately 1-3 days pre-op | 
| Change in Body Weight | Change in baseline body weight in pounds during the pre-operative period (V1-V2) | Approximately 1-3 days pre-op | 
| Change in Body Weight | Change in baseline body weight in pounds at second post operative visit | Approximately 1-3 days pre-op | 
| Physical Performance | Six-Minute Walk Test in meters during the pre-operative period (V1-V2). The Six Minute Walk test will be performed according to American Thoracic Society Guidelines. | Approximately 1-3 days pre-op | 
| Physical Performance | Gait Speed at usual pace | Approximately 2-4 weeks pre-op | 
| Physical Performance | Grip Strength . with a Jamar handgrip dynamometer . | Approximately 1-3 days pre-op | 
| Physical Performance | Sit-to-Stand .Time to 5th Stand will be performed according to the Short Performance Physical Battery. | Approximately 4 months post-op | 
| Assessment of Symptoms | Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep), at first post-operative visit. | Approximately 4 weeks post-op | 
| Assessment of Symptoms | Functional Assessment of Anorexia-Cachexia Therapy - FAACT, during the pre-operative period (V1-V2). | Approximately 1-3 days pre-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, prehabilitation, sarcopenia