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

NCT06712797 | Active Not Recruiting

• 1 other identifier: MCC-23462
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraductal Papillary Mucinous Neoplasm; Pancreatic Ductal Adenocarcinoma

Keywords

Pancreatic Ductal Adenocarcinoma; Intraductal Papillary Mucinous Neoplasm; Pancreatic Cancer

Outcome Measures

Primary Outcomes (4)

• Retention Feasibility

  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%).

  Up to 6 Months

• Physical Activity (PA) Adherence Feasibility

  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).

  Up to 6 Months

• Nutrition (N) Adherence Feasibility

  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)

  Up to 6 Months

• Acceptability of Lifestyle Modifications

  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.

  Up to 6 Months

Study Arms (1)

Physical Activity (PA) and Nutrition (N)

EXPERIMENTAL

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.

Behavioral: Physical Activity (PA); Behavioral: Nutrition (N)

Interventions

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.

Physical Activity (PA) and Nutrition (N)

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.

Physical Activity (PA) and Nutrition (N)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Miles for Moffitt: collaborator

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Links

• Moffitt Cancer Center Clinical Trials Website

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Exercise; Nutritional Status

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Jennifer Permuth, PhD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-arm trial evaluating the feasibility and acceptability of a 6-month Physical Activity (PA) and Nutrition (N) intervention for Intraductal Papillary Mucinous Neoplasm (IPMN) patients who are overweight and viscerally obese (on MRI) and/or have elevated levels of SOC incretin, cytokine, or adipokine biomarkers. Patients with IPMNs (\>15 mm) who have received or will receive care in Moffitt Cancer Center's Pancreas Interception Center (PIC) will be recruited.

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 2, 2024
• Study Start: February 19, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

US (1)