Pilot Study of a Multimodal Prehabilitation Pancreatic Cancer Program

NCT ID: NCT03865875

Last Updated: 2021-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-13
• Study Completion Date: 2024-08-31

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.

Conditions

Pancreatic Ductal Adenocarcinoma

Study Design

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

Study Groups

Multimodal Prehabilitation 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

Group Type: EXPERIMENTAL

Exercise Program

Intervention Type: BEHAVIORAL

Participants will start the exercise program within 2 weeks of enrollment and will continue until surgery. This program will consist of twice weekly individualized sessions with a trainer.

Nutrition Program

Intervention Type: BEHAVIORAL

Each patient enrolled will undergo nutritional assessment at their initial post-enrollment visit to develop an individualized nutrition plan to be implemented up until when the patient undergoes surgery.

Interventions

Exercise Program

Participants will start the exercise program within 2 weeks of enrollment and will continue until surgery. This program will consist of twice weekly individualized sessions with a trainer.

Intervention Type: BEHAVIORAL

Nutrition Program

Each patient enrolled will undergo nutritional assessment at their initial post-enrollment visit to develop an individualized nutrition plan to be implemented up until when the patient undergoes surgery.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adults age 18 years or older.
• Diagnosed within 8 weeks with upfront resectable, borderline resectable, or locally advanced unresectable PDAC as defined by the National Comprehensive Cancer Network (NCCN).
• Planning to undergo TNT at MGH.
• Planning to receive modified FOLFIRINOX for neoadjuvant chemotherapy.
• Planning to undergo surgical resection of PDAC at MGH.
• Verbal fluency in English.

Exclusion Criteria

• Metastatic disease.
• Previous treatment for pancreas adenocarcinoma and no prior therapy for any cancer within 5 years.
• Known history of cognitive or psychologic impairment.
• Known history of physical impairment such as immobility, use of walking aids, or required wheelchair use.
• Known history of the following orthopedic comorbidities: advanced osteoarthritis or rheumatoid arthritis, mobility-limiting amputations, orthopedic injuries, or widespread chronic pain (e.g. fibromyalgia).
• Known history of the following pulmonary comorbidities: severe chronic obstructive pulmonary disease (COPD) defined as FEV1 ≤ 50%, emphysema, interstitial lung disease, and/or use of supplemental oxygen.
• Known history of the following cardiovascular comorbidities: uncontrolled hypertension, severe congestive heart failure (NYHA Class IV), and/or myocardial infarction within the last 6 months.
• Inability to tolerate diet through routine oral routes and/or patients with strict nutritional restrictions, allergies, and/or dietary preferences.

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

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Motaz Qadan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Motaz Qadan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Naomi Sell, MD, MHS

Role: CONTACT

nsell@partners.org

650-868-9440

Motaz Qadan, MD, PhD

Role: CONTACT

mqadan@mgh.harvard.edu

617-643-5153

Facility Contacts

Motaz Qadan, MD, PhD

Role: primary

mqadan@mgh.harvard.edu

617-643-5153

Other Identifiers

18-635

Identifier Type: -

Identifier Source: org_study_id