A Supervised Prehabilitation Program for Patients With Pancreatic Cancer

NCT ID: NCT05692323

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-04
• Study Completion Date: 2027-04-01

Brief Summary

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

Detailed Description

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).

Conditions

Pancreas Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Supervised Prehabilitation Exercise Program

Group Type: EXPERIMENTAL

PREHAB

Intervention Type: OTHER

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 accumulate a total of 150 minutes per week of moderate aerobic training at home which is measured by a wrist worn FitBit device.

Interventions

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 accumulate a total of 150 minutes per week of moderate aerobic training at home which is measured by a wrist worn FitBit device.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Philip Chang

Sponsor-Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philip Chang, DO

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

IIT2021-18-CHANG-PREHAB

Identifier Type: -

Identifier Source: org_study_id