Exercise and Nutrition to Improve Pancreatic Cancer Outcomes

NCT ID: NCT03256201

Last Updated: 2024-08-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-01
• Study Completion Date: 2025-03-31

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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 preferred mode of endurance training, a home ergometer is provided for use with arms and/or legs.

Group Type: EXPERIMENTAL

Nutritional Counseling

Intervention Type: BEHAVIORAL

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.

Standard Exercise

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Nutritional Counseling

Intervention Type: BEHAVIORAL

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.

Enhanced Exercise

Intervention Type: BEHAVIORAL

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.

Interventions

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 intake.

Intervention Type: 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 preferred mode of endurance training, a home ergometer is provided for use with arms and/or legs.

Intervention Type: 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 no other preferred mode of endurance training, a home ergometer is provided for use with arms and/or legs.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth Hile, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

Faculty

Locations

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Countries

United States

Other Identifiers

5991

Identifier Type: -

Identifier Source: org_study_id