Pancreatic Ductal AdenocarcinomaPANTHER-PICNCT06712797
Physical Activity and Nutrition to Halt Elevated Risk in the Pancreas Interception Center
A study testing Physical Activity (PA) and Nutrition (N) in people with Pancreatic Ductal Adenocarcinoma and Intraductal Papillary Mucinous Neoplasm, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma, Intraductal Papillary Mucinous Neoplasm
- What is being tested?
- Physical Activity (PA) and Nutrition (N)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2025to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Activity and Nutrition to Halt Elevated Risk in the Pancreas Interception Center (PANTHER-PIC)
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.
- Being tested
- Physical Activity (PA), Nutrition (N)
- Keywords
- Pancreatic Ductal Adenocarcinoma, Intraductal Papillary Mucinous Neoplasm, Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity (PA)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Physical Activity (PA); Behavioral: Nutrition (N) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: 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).
Measured: 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)
Measured: 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.
Measured: Up to 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start19 Feb 2025
- Primary completionSep 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Miles for Moffitt
- Responsible party
- Sponsor
- Investigators
- Jennifer Permuth, PhD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712797
- Sponsor's protocol ID
- MCC-23462
- Acronym
- PANTHER-PIC
- Status last verified
- Mar 2026
- First submitted
- 27 Nov 2024
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Nutrition to Halt Elevated Risk in the Pancreas Interception Center (PANTHER-PIC)
- ClinicalTrials.gov ID
- NCT06712797
- Acronym / sponsor ID
- PANTHER-PIC / MCC-23462
- Keywords
- Pancreatic Ductal Adenocarcinoma, Intraductal Papillary Mucinous Neoplasm, Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Miles for Moffitt
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 2 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Physical Activity (PA) and Nutrition (N) | Experimental | Behavioral: Physical Activity (PA), Behavioral: Nutrition (N)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activity (PA)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. | Behavioural | Physical Activity (PA) and Nutrition (N) |
| Nutrition (N)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. | Behavioural | Physical Activity (PA) and Nutrition (N) |
Primary outcome
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%).
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).
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)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Permuth, PhD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity (PA) and Nutrition (N) in people with Pancreatic Ductal Adenocarcinoma and Intraductal Papillary Mucinous Neoplasm, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention Feasibility (time frame: Up to 6 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.