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Active, Not Recruiting

NCT Number: NCT06712797

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pancreatic Ductal Adenocarcinoma Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Intraductal Papillary Mucinous Neoplasm Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity (PA)

Behavioral

Participants will receive a Fitbit (Inspire 3, Google LLC, Mountain View, CA, USA) to encourage and self-monitor Physical Activity (PA) using "active minutes," which approximate moderate-to-vigorous PA.

Fitbits will be synced to a HIPAA-compliant platform created by Moffitt's Biostatistics and Bioinformatics Shared Resource (BBSR).

Study personnel will view active minutes to provide individualized feedback and encourage progression. Weekly feedback will encourage participants to increase active minutes by 10% until achieving ≥ 150 minutes to meet cancer prevention recommendations.

Participants who reach ≥ 150 active minutes will be encouraged to maintain or exceed recommendations.

Nutrition (N)

Behavioral

Participants will undergo counseling at baseline (T0) to address nutritional symptoms and provide targets for daily calories and protein following a Mediterranean diet. This diet includes a high intake of vegetables, legumes, fruits, and unsaturated fatty acids, low intake of saturated fatty acids, and a moderately high intake of fish.

Total caloric intake will be calculated. A standard breakdown of 40% carbohydrates, 30% fats and 30% protein will be used. Individuals will review this calculation during their office encounters and follow these values using the FitBit, application, which will adjust to their daily energy expenditure.

Additional counseling (in-person or via Zoom) will occur at baseline (T0) + 12 weeks to gauge progress toward calorie and protein targets, monitor weight change, and guide dietary changes.

Participants will log daily food intake and self-monitor progress toward calorie and protein goals.

Primary outcomes

  1. Retention Feasibility

    Time frame: 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%).

  2. Physical Activity (PA) Adherence Feasibility

    Time frame: 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).

  3. Nutrition (N) Adherence Feasibility

    Time frame: 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)

  4. Acceptability of Lifestyle Modifications

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • Miles for Moffitt

Registry information

Official study title

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

Acronym: PANTHER-PIC

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 2, 2024
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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