Clinical trial · Interventional
Physical Activity and Nutrition to Halt Elevated Risk in the Pancreas Interception Center
Physical Activity and Nutrition to Halt Elevated Risk in the Pancreas Interception Center (PANTHER-PIC)
NCT06712797CI-TRIAL-00105512PANTHER-PICactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intraductal Papillary Mucinous Neoplasm | Pancreatic Intraductal Papillary Mucinous Neoplasm | ALIAS | 0.90 |
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nutrition (N) | Behavioral | — | UNRESOLVED |
| Physical Activity (PA) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Physical Activity (PA) and Nutrition (N)
- 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.
- interventionNames
- Behavioral: Physical Activity (PA)
- Behavioral: Nutrition (N)
Primary outcomes (4)
- measure
- Retention Feasibility
- timeFrame
- Up to 6 Months
- description
- 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%).
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.