Pilot Study of a Multimodal Prehabilitation Pancreatic Cancer Program

Mass General Brigham

Status: Enrolling

Conditions: Pancreatic Ductal Adenocarcinoma

Treatments: Behavioral: Nutrition Program; Behavioral: Exercise Program

Study type: Interventional

Funder types: Other

Identifiers

NCT03865875

18-635

Details and patient eligibility

About

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)

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Multimodal Prehabilitation Program

Experimental group

Description:

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

Treatment:

Behavioral: Nutrition Program

Behavioral: Exercise Program