Physical Activity and Nutrition to Halt Elevated Risk in the Pancreas Interception Center (NCT06712797) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Physical Activity and Nutrition to Halt Elevated Risk in the Pancreas Interception Center
United States24 participantsStarted 2025-02-19
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Retention Feasibility
Timeframe: Up to 6 Months
2
Physical Activity (PA) Adherence Feasibility
Timeframe: Up to 6 Months
3
Nutrition (N) Adherence Feasibility
Timeframe: Up to 6 Months
4
Acceptability of Lifestyle Modifications
Timeframe: Up to 6 Months
Trial details
NCT IDNCT06712797
SponsorH. Lee Moffitt Cancer Center and Research Institute