A Supervised Prehabilitation Program For Patients With Pancreatic Cancer

Study Overview

A Supervised Prehabilitation Program for Patients With Pancreatic Cancer

The purpose of this study is to assess the use of an exercise program in people with pancreatic cancer.

Attendance to exercise sessions as well as impacts on healthcare utilization, muscle mass, quality of life, physical activity, and post-operative outcomes when applicable will be monitored. Study participants will participant in a supervised, in-person exercise program 3 times per week for 6 weeks. Participants will receive a Fitbit to be worn continuously during the study and complete surveys and exercise tests at specified timepoints (Baseline, Post-Intervention Evaluation and 3-Month Follow Up).

Pancreas Cancer

OTHER: PREHAB

IIT2021-18-CHANG-PREHAB

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 2023-01-11	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-04-01
First Submitted that Met QC Criteria 2023-01-11	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-04-03
First Posted (ACTUAL) 2023-01-20	Results First Posted N/A	Last Verified 2025-04

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:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Supervised Prehabilitation Exercise Program	OTHER: PREHAB 6-week supervised PREHAB program. Each week of the program consists of 3 x 1 hour supervised training sessions made up of moderate intensity aerobic training and resistance training. In addition to the supervised sessions, patients will be instructed to a

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Supervised Prehabilitation Exercise Program

OTHER: PREHAB

6-week supervised PREHAB program. Each week of the program consists of 3 x 1 hour supervised training sessions made up of moderate intensity aerobic training and resistance training. In addition to the supervised sessions, patients will be instructed to a

Primary Outcome Measures	Measure Description	Time Frame
PREHAB Program feasibility will be measured by tracking participant attendance at PREHAB sessions. PREHAB will be considered feasible if 50% of participants attend at least 60% of scheduled sessions.	PREHAB session feasibility is defined as at least 50% of participants attending at least 60% of scheduled sessions	From Baseline to 3 Months

Secondary Outcome Measures	Measure Description	Time Frame
PREHAB Program safety will be assessed through the reporting of unanticipated problems from the baseline visit through to the 3 Month visit.	PREHAB program safety will be evaluated by monitoring unanticipated problems involving risk to subjects or others (UPIRSO).	From Baseline to 3 Months

Contacts and Locations

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

Study Contact

Name: Philip Chang, DO

Phone Number: 310 467 4498

Email: philip.chang@cshs.org

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:
18 Years

Accepts Healthy Volunteers:

Pancreatic cancer diagnosis (any stage)
Age ≥ 18 years
Independent ambulation and activities of daily living (Discretion of referring/ treating oncologist)
Godin-Shephard Leisure-Time Physical Activity Questionnaire score of ≤ 23
Physically able to complete functional assessments including 6-minute walk test, hand grip strength, short performance physical battery and performance metrics
Answers no to all questions on PAR-Q OR is cleared to participate by their treating oncologist
Ability to read, write and understand English
Written informed consent obtained from subject and ability for subjects to comply with the requirements of the study

Access to a smart device capable of Fitbit syncing and accessing the online Pain portal (www.painguide.com)

Has undergone or plans to undergo resection surgery prior to projected completion of PREHAB exercise intervention
Current pregnancy

Using a pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implants (removable hearing aids permitted), or other electronic medical equipment, unless the PI deems study participation safe.

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: Philip Chang, DO, Cedars-Sinai Medical Center

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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Resources

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Caregivers

Clinical Trial Record