Pilot Study of a Multimodal Prehabilitation Pancreatic Cancer Program

Not Applicable

• Conditions: Pancreatic Ductal Adenocarcinoma
• Interventions: Behavioral: Exercise Program; Behavioral: Nutrition Program

• Registration Number: NCT03865875
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The purpose of this research is to explore the benefits of an exercise and nutrition program during total neoadjuvant therapy (TNT) in preparation for surgery for participants that have pancreatic ductal adenocarcinoma (PDAC)

Detailed Description

This research study involves an exercise and nutrition program that will consist of twice weekly exercise sessions and discussion with a nutritionist with possible nutrition supplementation.

The names of the study interventions involved in this study are:

* Exercise Intervention

* Nutrition Intervention

The research study procedures include: screening for eligibility, study evaluations, and follow up visits.

Study Timeline

• Study First Submitted: 2019-03-05
• Study First Submitted QC: 2019-03-05
• Study First Posted: 2019-03-07
• Study Start: 2019-08-13
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-13
• Last Update Posted: 2021-05-17
• Primary Completion: 2023-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Multimodal Prehabilitation Program	Exercise Program	Pretreatment exercise program and nutrition program -The prehabilitation intervention will include the following components: (1) a standardized fitness program and (2) nutritional counseling and optimization. Patients are enrolled in the program within 8 weeks of being diagnosed and continued until operation
Multimodal Prehabilitation Program	Nutrition Program	Pretreatment exercise program and nutrition program -The prehabilitation intervention will include the following components: (1) a standardized fitness program and (2) nutritional counseling and optimization. Patients are enrolled in the program within 8 weeks of being diagnosed and continued until operation

Primary Outcome Measures

Name	Time	Method
Number of participants to complete prehabilitation program	1 year	At least 50% (95% confidence interval +/- 16%) of participants will complete 50% of the components of the prehabilitation program.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States