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

H. Lee Moffitt Cancer Center and Research Institute

Status: Enrolling

Conditions: Pancreatic Ductal Adenocarcinoma; Intraductal Papillary Mucinous Neoplasm

Treatments: Behavioral: Nutrition (N); Behavioral: Physical Activity (PA)

Study type: Interventional

Funder types: Other

Identifiers

NCT06712797

MCC-23462

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

• 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Physical Activity (PA) and Nutrition (N)

Experimental group

Description:

Physical Activity: Participants will perform 150 minutes/week of moderate to vigorous Physical Activity per week. Participants will self-monitor physical activity using "active minutes" that approximate moderate to vigorous physical activity via a Fitbit device. Nutrition: Participants will undergo counseling appointments to address nutritional symptoms and will be given targets for daily calorie and protein intake following a Mediterranean diet.

Treatment:

Behavioral: Physical Activity (PA)

Behavioral: Nutrition (N)