Pilot Study of a Multimodal Prehabilitation Pancreatic Cancer Program

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study of a Multimodal Prehabilitation Pancreatic Cancer Program

Conditions
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Pancreatic Ductal Adenocarcinoma

Intervention / Treatment
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* Behavioral: Exercise Program
* Behavioral: Nutrition Program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multimodal Prehabilitation Program<br>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 | Behavioral: Exercise Program<br>* 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.<br>Behavioral: Nutrition Program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants to complete prehabilitation program | At least 50% (95% confidence interval +/- 16%) of participants will complete 50% of the components of the prehabilitation program. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic Ductal Adenocarcinoma, Total Neoadjuvant Therapy, Prehabilitation, Exercise, Nutrition, Optimization, Surgery