An interventional study of Nutritional Counseling and Standard Exercise in Pancreatic Cancer, sponsored by University of Oklahoma. Active, not recruiting at 1 site in United States. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2024-08-16.
Sponsored by University of Oklahoma · Not applicable, Interventional, and Supportive care
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.
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.
Exclusion:
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 · Behavioral: 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 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 · Behavioral: Enhanced Exercise
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.
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.
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.
Accrual
The percentage of eligible patients enrolled
Time frame: 2 year
Retention
Retention as the percentage of enrolled patients retained assessment point
Time frame: 2 year
Adherence
Adherence will be estimated as percentage of prescribed exercise completed based on exercise diaries and phone calls
Time frame: 2 year
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.
Time frame: Approximately 1-3 days pre-op
Change in Body Weight
Change in baseline body weight in pounds during the pre-operative period (V1-V2)
Time frame: Approximately 1-3 days pre-op
Change in Body Weight
Change in baseline body weight in pounds at second post operative visit
Time frame: 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.
Time frame: Approximately 1-3 days pre-op
Physical Performance
Gait Speed at usual pace
Time frame: Approximately 2-4 weeks pre-op
Physical Performance
Grip Strength . with a Jamar handgrip dynamometer .
Time frame: 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.
Time frame: Approximately 4 months post-op
Assessment of Symptoms
Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep), at first post-operative visit.
Time frame: Approximately 4 weeks post-op
Assessment of Symptoms
Functional Assessment of Anorexia-Cachexia Therapy - FAACT, during the pre-operative period (V1-V2).
Time frame: Approximately 1-3 days pre-op
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Oklahoma