Physical Activity and Nutrition to Halt Elevated Risk in the Pancreas Interception Center

Not Applicable

Recruiting

• Conditions: Pancreatic Ductal Adenocarcinoma; Intraductal Papillary Mucinous Neoplasm

• Registration Number: NCT06712797
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-27
• Study First Submitted QC: 2024-11-27
• Study First Posted: 2024-12-02
• Study Start: 2025-02-19
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-07
• Primary Completion: 2027-11
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Retention Feasibility	Up to 6 Months	Retention feasibility will be measured based on the percentage of enrolled participants who complete study assessments during the 6-month duration of enrollment (baseline T0 through follow-up T1) Target: ≥70%).
Physical Activity (PA) Adherence Feasibility	Up to 6 Months	Adherence to Physical Activity (PA) will be based on achievement of activity minute goals (≥ 150 minutes).; Target: 70% of participants achieve activity minute goals in ≥75% of full weeks between baseline through follow-up (T0-T1).
Nutrition (N) Adherence Feasibility	Up to 6 Months	Adherence to Nutrition (N) will be based on completion of counseling appointments (target: 70% of participants complete both appointments) and diet logging.; Target: 70% of participants log diet on ≥ 50% of days between baseline through follow-up (T0-T1)
Acceptability of Lifestyle Modifications	Up to 6 Months	Acceptability will be assessed at T1 with the Participant Evaluation of Feasibility and Acceptability questionnaire, adapted to fit intervention conditions used in this study.; This questionnaire includes Likert Scale and open-ended questions assessing difficulty and appropriateness of the Physical Acitivity (PA) and Nutrition (N) intervention components, perceived benefits, interactions with study personnel, study materials, and baseline/follow-up testing. Acceptability will be assessed on an item-by-item basis and as average item score, with scores ≥4 ("agree" to "strongly agree") indicating acceptability.

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States