Clinical Trial 23462

• Overview

  Study Title:

  Physical Activity and Nutrition to Halt Elevated Risk in the Pancreas Interception Center (PANTHER-PIC)

  Summary:

  The purpose of this Study is to assist in implementing a practical, easy-to-adopt lifestyle intervention that optimizes patient outcomes and minimizes pancreatic ductal adenocarcinoma (PDAC) risk. The preliminary data to be generated will assist with designing and implementing a future randomized controlled exercise and dietary interventional trial designed for intraductal papillary mucinous neoplasm (IPMN) patients.

  Objective:

  Aim 1. Evaluate the feasibility and acceptability of a 6-month physical activity (PA) and nutrition (N) intervention for patients with IPMNs and additional risk factors for PDAC development (e.g., excess weight, visceral obesity, elevated metabolic or inflammatory biomarkers). Aim 2. Explore changes in body composition (e.g., fat mass, muscle mass, body fat %) biomarkers (e.g., insulin resistance, inflammation, fat signaling), functional fitness, diet, and quality of life (QOL) among participants. Aim 3. Explore differences in standard of care biometric and biomarker outcomes between participants and patients in a retrospective, usual care comparison group who have IPMNs and frequency-match on key clinicodemographic characteristics.

• Inclusion Criteria

  Inclusion Criteria:
  • Age 18 years or older
  • Endoscopically, radiologically, or biopsy-proven pancreatic intraductal papillary mucinous neoplasm (IPMN) over 15 mm in size
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Ability to sign informed consent
  • Ability to read and speak English or Spanish
  • Body Mass Index (BMI) greater than or equal to 25 kg/m2
  • Visceral obesity based on MRI quantification of visceral and subcutaneous fat; ratio of visceral to subcutaneous fat area greater than 0.4 and/or elevated cytokine, incretin or adipokine biomarkers

• Exclusion Criteria

  Exclusion Criteria:
  • No diagnosis of an IPMN
  • IPMN with high grade dysplasia, cancer or other high-risk features
  • Screen failure for exercise safety
  • Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease
  • Recent fracture or acute musculoskeletal injury
  • Numeric pain rating scale of 7 or more out of 10
  • Myopathic or rheumatologic disease that impacts physical function

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