Exercise and Nutrition to Improve Pancreatic Cancer Outcomes
- Conditions
- Pancreatic Cancer
- Interventions
- Behavioral: Nutritional CounselingBehavioral: Standard ExerciseBehavioral: Enhanced Exercise
- Registration Number
- NCT03256201
- Lead Sponsor
- University of Oklahoma
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 95
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Exercise Group Standard Exercise 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. Enhanced Exercise Group Nutritional Counseling 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. Enhanced Exercise Group Enhanced Exercise 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. Standard Exercise Group Nutritional Counseling 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.
- Primary Outcome Measures
Name Time Method Accrual 2 year The percentage of eligible patients enrolled
Retention 2 year Retention as the percentage of enrolled patients retained assessment point
Adherence 2 year Adherence will be estimated as percentage of prescribed exercise completed based on exercise diaries and phone calls
- Secondary Outcome Measures
Name Time Method Physical Performance Approximately 4 months post-op Sit-to-Stand .Time to 5th Stand will be performed according to the Short Performance Physical Battery.
Quality of Life Assessment Approximately 1-3 days pre-op 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.
Assessment of Symptoms Approximately 1-3 days pre-op Functional Assessment of Anorexia-Cachexia Therapy - FAACT, during the pre-operative period (V1-V2).
Change in Body Weight Approximately 1-3 days pre-op Change in baseline body weight in pounds at second post operative visit
Trial Locations
- Locations (1)
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States