Exercise And Nutrition To Improve Pancreatic Cancer Outcomes

Study Overview

Exercise and Nutrition to Improve Pancreatic Cancer Outcomes

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.

Pancreatic Cancer

BEHAVIORAL: Nutritional Counseling
BEHAVIORAL: Standard Exercise
BEHAVIORAL: Enhanced Exercise

5991

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2017-05-26	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-08-15
First Submitted that Met QC Criteria 2017-08-18	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-08-16
First Posted (ACTUAL) 2017-08-21	Results First Posted N/A	Last Verified 2024-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Supportive Care

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Single

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Standard Exercise Group 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 preferre	BEHAVIORAL: Nutritional Counseling 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 intak 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 AROM of upper and lower body. If no other preferre
EXPERIMENTAL: Enhanced Exercise Group 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 n	BEHAVIORAL: Nutritional Counseling 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 intak BEHAVIORAL: 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 n

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Standard Exercise Group

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 preferre

BEHAVIORAL: Nutritional Counseling

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 intak

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 AROM of upper and lower body. If no other preferre

EXPERIMENTAL: Enhanced Exercise Group

BEHAVIORAL: Nutritional Counseling

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 intak

BEHAVIORAL: 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 n

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
30 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Elizabeth Hile, PhD, PT, Faculty

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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