Lifestyle changes to reduce pancreatic cancer risk
Physical Activity and Nutrition to Halt Elevated Risk in the Pancreas Interception Center (PANTHER-PIC)
NA · H. Lee Moffitt Cancer Center and Research Institute · NCT06712797
This study is trying to see if changes in diet and exercise can help people with a certain type of pancreatic growth lower their risk of developing pancreatic cancer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute (other) |
| Locations | 1 site (Tampa, Florida) |
| Trial ID | NCT06712797 on ClinicalTrials.gov |
What this trial studies
This study focuses on implementing a practical lifestyle intervention that combines physical activity and nutrition to improve patient outcomes and reduce the risk of pancreatic ductal adenocarcinoma (PDAC). Participants will be individuals diagnosed with pancreatic intraductal papillary mucinous neoplasm (IPMN) over 15 mm in size. The intervention aims to optimize health through tailored exercise and dietary modifications, monitored for effectiveness. The study will assess the feasibility and impact of these lifestyle changes on the progression of pancreatic conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of IPMN over 15 mm and a BMI of 25 kg/m2 or higher.
Not a fit: Patients with high-grade dysplasia, cancer, or other high-risk features of IPMN will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly lower the risk of developing pancreatic cancer in at-risk patients.
How similar studies have performed: Other studies have shown promising results with lifestyle interventions in cancer prevention, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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: * 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
Where this trial is running
Tampa, Florida
- Moffitt Cancer Center — Tampa, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Shaffer Mok, MD — Moffitt Cancer Center
- Study coordinator: Jennifer Permuth, PhD
- Email: Jenny.Permuth@moffitt.org
- Phone: 813-745-5744
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pancreatic Ductal Adenocarcinoma, Intraductal Papillary Mucinous Neoplasm, Pancreatic Cancer