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Exercise and Nutrition to Improve Pancreatic Cancer Outcomes

Primary Purpose

Pancreatic Cancer

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Nutritional Counseling

Standard Exercise

Enhanced Exercise

About this trial

This is an interventional supportive care trial for Pancreatic Cancer focused on measuring Cancer, prehabilitation, sarcopenia

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Oklahoma Health Sciences CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Standard Exercise Group

Enhanced Exercise Group

Arm Description

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.

Outcomes

Primary Outcome Measures

Accrual

The percentage of eligible patients enrolled

Retention

Retention as the percentage of enrolled patients retained assessment point

Adherence

Adherence will be estimated as percentage of prescribed exercise completed based on exercise diaries and phone calls

Secondary Outcome Measures

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.

Change in Body Weight

Change in baseline body weight in pounds during the pre-operative period (V1-V2)

Change in Body Weight

Change in baseline body weight in pounds at second post operative visit

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.

Physical Performance

Gait Speed at usual pace

Physical Performance

Grip Strength . with a Jamar handgrip dynamometer .

Physical Performance

Sit-to-Stand .Time to 5th Stand will be performed according to the Short Performance Physical Battery.

Assessment of Symptoms

Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep), at first post-operative visit.

Assessment of Symptoms

Functional Assessment of Anorexia-Cachexia Therapy - FAACT, during the pre-operative period (V1-V2).

Full Information

NCT ID

NCT03256201

First Posted

May 26, 2017

Last Updated

May 15, 2023

Sponsor

University of Oklahoma

1. Study Identification

Unique Protocol Identification Number

NCT03256201

Brief Title

Exercise and Nutrition to Improve Pancreatic Cancer Outcomes

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 1, 2016 (Actual)

Primary Completion Date

April 2024 (Anticipated)

Study Completion Date

August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Oklahoma

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

Keywords

Cancer, prehabilitation, sarcopenia

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard Exercise Group

Arm Type

Experimental

Arm Description

Arm Title

Enhanced Exercise Group

Arm Type

Experimental

Arm Description

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

Intervention Name(s)

Nutritional Counseling

Intervention Description

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

Intervention Name(s)

Standard Exercise

Intervention Description

Intervention Type

Behavioral

Intervention Name(s)

Enhanced Exercise

Intervention Description

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.

Primary Outcome Measure Information:

Title

Accrual

Description

The percentage of eligible patients enrolled

Time Frame

2 year

Title

Retention

Description

Retention as the percentage of enrolled patients retained assessment point

Time Frame

2 year

Title

Adherence

Description

Adherence will be estimated as percentage of prescribed exercise completed based on exercise diaries and phone calls

Time Frame

2 year

Secondary Outcome Measure Information:

Title

Quality of Life Assessment

Description

Time Frame

Approximately 1-3 days pre-op

Title

Change in Body Weight

Description

Change in baseline body weight in pounds during the pre-operative period (V1-V2)

Time Frame

Approximately 1-3 days pre-op

Title

Change in Body Weight

Description

Change in baseline body weight in pounds at second post operative visit

Time Frame

Approximately 1-3 days pre-op

Title

Physical Performance

Description

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

Title

Physical Performance

Description

Gait Speed at usual pace

Time Frame

Approximately 2-4 weeks pre-op

Title

Physical Performance

Description

Grip Strength . with a Jamar handgrip dynamometer .

Time Frame

Approximately 1-3 days pre-op

Title

Physical Performance

Description

Sit-to-Stand .Time to 5th Stand will be performed according to the Short Performance Physical Battery.

Time Frame

Approximately 4 months post-op

Title

Assessment of Symptoms

Description

Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep), at first post-operative visit.

Time Frame

Approximately 4 weeks post-op

Title

Assessment of Symptoms

Description

Functional Assessment of Anorexia-Cachexia Therapy - FAACT, during the pre-operative period (V1-V2).

Time Frame

Approximately 1-3 days pre-op

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Abby Cha, BS

Phone

405 271-1529

abby-cha@ouhsc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Rachel Neuhold, PT

Phone

405-271-7635

rachel.neuhold@ouhealth.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elizabeth Hile, PhD, PT

Organizational Affiliation

Faculty

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Oklahoma Health Sciences Center

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Abby Cha, BS

Phone

405-271-1529

abby-cha@ouhsc.edu

First Name & Middle Initial & Last Name & Degree

Elizabeth Hile, PhD, PT

Phone

405-271-2273

Elizabeth-Hile@ouhsc.edu

12. IPD Sharing Statement

Plan to Share IPD

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