A Supervised Prehabilitation Program for Patients With Pancreatic Cancer

Pancreas Cancer Clinical Trial

— PREHAB  

Official title:

A Supervised Prehabilitation Program for Patients With Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05692323
• Other study ID #: IIT2021-18-CHANG-PREHAB
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2023
• Est. completion date: April 1, 2026

Study information

• Verified date: April 2024
• Source: Cedars-Sinai Medical Center
• Contact: Philip Chang, DO
• Phone: 310 467 4498
• Email: philip.chang[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: April 1, 2026
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Inclusion criteria for remote monitoring of physical activity (Fitbit) and online Pain portal only (failure to meet inclusion criterion below should not preclude subjects from participating in main 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

Exclusion criteria for remote monitoring component of the study with Fitbit only (failure to meet exclusion criterion below should not preclude the subject from participating in main study):

• 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.

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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