Lifestyle Changes for Pancreatic Cancer Risk Reduction

(PANTHER-PIC Trial)

Overseen By Jennifer Permuth, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Disqualifiers: High grade dysplasia, Unstable cardiac, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a lifestyle program aimed at reducing the risk of pancreatic cancer. Participants will follow a plan involving regular physical activity and a Mediterranean diet, designed to improve health and lower cancer risk. Individuals diagnosed with a specific pancreas condition (IPMN) and a BMI of 25 or higher, indicating overweight or obesity, might be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to research that could lead to improved health strategies for reducing cancer risk.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these lifestyle interventions are safe for reducing pancreatic cancer risk?

Research has shown that both eating well and staying active can lower the risk of pancreatic cancer. For example, one study found that women who were overweight or obese had a reduced chance of developing pancreatic cancer when they followed a low-fat diet. This finding suggests that dietary changes, such as adopting a Mediterranean diet, could benefit health.

Physical activity is also linked to a lower risk of pancreatic cancer. Several studies have demonstrated that people who exercise more tend to experience fewer cases of this cancer. Exercise not only reduces cancer risk but also enhances overall fitness and well-being.

In general, making these lifestyle changes—improving diet and increasing physical activity—is safe. Most people adapt well to these changes, which can lead to better health. No major negative effects have been reported from these changes, making them a safe choice for those aiming to lower their risk of pancreatic cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of lifestyle changes like nutrition and physical activity for pancreatic cancer risk reduction because they offer a non-invasive, holistic approach that differs from traditional treatments. Unlike chemotherapy or surgery, which directly target cancer cells or tumors, these lifestyle interventions focus on modifying risk factors, potentially preventing the disease from developing in the first place. The use of a Mediterranean diet and personalized physical activity plans, monitored with devices like Fitbits, introduces a proactive way to manage health, emphasizing overall wellness and long-term benefits. This approach could empower individuals to take an active role in their health, making it a promising area of research.

What evidence suggests that these lifestyle changes are effective for reducing pancreatic cancer risk?

Research has shown that both exercise and a healthy diet can lower the risk of pancreatic cancer. This trial involves participants in a combination of physical activity and nutrition interventions. Regular exercise, particularly intense activities, reduces inflammation and promotes overall health, which is linked to a lower risk of this cancer. Participants will engage in 150 minutes of moderate to vigorous physical activity each week. On the dietary front, following a Mediterranean diet—rich in fruits, vegetables, and healthy fats—is also associated with a reduced risk. Participants will receive counseling to address nutritional symptoms and will have targets for daily calorie and protein intake. Together, these lifestyle changes can significantly reduce the risk of pancreatic cancer. ^{3 6 7 8 9}

Who Is on the Research Team?

Shaffer Mok, MD

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals at risk of pancreatic cancer, specifically PDAC. It's designed to see if lifestyle changes like increased physical activity and improved nutrition can help reduce their risk. Details on who exactly can join are not provided, but typically participants would need to meet certain health criteria.

Inclusion Criteria

Body Mass Index (BMI) greater than or equal to 25 kg/m2

My pancreatic growth is confirmed and larger than 15 mm.

I am able to get out of my bed or chair and move around.

Exclusion Criteria

Screen failure for exercise safety

I have recently had a bone fracture or muscle injury.

My condition involves high-risk pancreatic cysts or cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lifestyle Intervention

Participants engage in a lifestyle intervention involving 150 minutes/week of moderate to vigorous physical activity and nutritional counseling following a Mediterranean diet.

24 weeks

Regular self-monitoring and counseling appointments

Follow-up

Participants are monitored for retention, adherence, and acceptability of lifestyle modifications.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nutrition
• Physical Activity

Trial Overview The study is testing whether a combination of regular physical activity (PA) and nutritional guidance (N) can positively impact the health outcomes of those at elevated risk for pancreatic ductal adenocarcinoma (PDAC).

How Is the Trial Designed?

Group I: Physical Activity (PA) and Nutrition (N) Experimental Treatment 2 Interventions

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 Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Miles for Moffitt

Collaborator

Trials

1

Recruited

20+

Published Research Related to This Trial

In a case-control study of 186 pancreatic cancer cases and 554 controls, light and moderate physical activity were associated with a reduced risk of pancreatic cancer, highlighting the importance of maintaining an active lifestyle.

Dietary factors also played a significant role, with higher intakes of saturated and polyunsaturated fats increasing cancer risk, while higher fiber intake was linked to a reduced risk, suggesting that lifestyle choices can influence insulin resistance and pancreatic cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity, diet, and pancreatic cancer: a population-based, case-control study in Minnesota. Zhang, J., Dhakal, IB., Gross, MD., et al.[2022]

Exercise is feasible and can improve physical fitness and quality of life in patients undergoing treatment for pancreatic cancer, based on a review of 24 clinical trials.

However, the benefits of exercise may decrease as the disease progresses, indicating a need for more rigorous research to establish effective exercise protocols tailored for pancreatic cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of exercise on pancreatic cancer patients during treatment: a scoping review of the literature. Gupta, P., Hodgman, CF., Schadler, KL., et al.[2023]

A scoping review of 15,708 articles identified only 62 relevant studies on diet and exercise interventions for patients with pancreatic cancer, highlighting a significant gap in research on this topic.

Most studies focused on dietary interventions, particularly omega-3 fatty acids, while only a small number examined exercise, indicating a need for more comprehensive research to understand how these interventions can help combat malnutrition and muscle wasting in pancreatic cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and Exercise Interventions in Patients With Pancreatic Cancer: A Scoping Review. Kasvis, P., Kilgour, RD.[2022]

A 12-week supervised exercise program for 22 patients with pancreatic cancer showed significant improvements in functional ability, muscle strength, and balance, with no serious adverse events reported, indicating that exercise is safe during nonsurgical treatment.

Patients who continued exercising beyond the initial 12 weeks maintained their physical improvements, suggesting that ongoing exercise may be beneficial for preserving health in pancreatic cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Clinic-Based Exercise Program in Patients with Pancreatic Cancer Undergoing Nonsurgical Treatment. Luo, H., Galvão, DA., Newton, RU., et al.[2023]

A 12-week multimodal lifestyle intervention for a 55-year-old woman with advanced pancreatic cancer was found to be safe and feasible, showing significant improvements in body weight and physical fitness.

The intervention also led to reductions in psychological distress, anxiety, and depression, suggesting that integrated supportive care can effectively manage symptoms of metastatic cancer and cachexia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary lifestyle intervention to manage pancreatic cancer-related cachexia: a case report. Avancini, A., Trestini, I., Tregnago, D., et al.[2023]

A systematic review of 28 studies found that higher levels of total physical activity and occupational activity are associated with a reduced risk of pancreatic cancer, with relative risks of 0.72 and 0.75, respectively.

Moderate physical activity may offer more protection against pancreatic cancer compared to vigorous activity, although the results were not statistically significant, indicating the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can physical activity modulate pancreatic cancer risk? a systematic review and meta-analysis. O'Rorke, MA., Cantwell, MM., Cardwell, CR., et al.[2018]

Pancreatic cancer is a highly lethal disease with increasing incidence, often diagnosed too late for effective treatment due to a lack of early detection biomarkers.

Modifiable lifestyle factors, such as high alcohol and processed meat consumption, obesity, diabetes, and smoking, significantly increase the risk of developing pancreatic cancer, suggesting that addressing these factors could help prevent many new cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of lifestyle and environment risk factors for pancreatic cancer. Zanini, S., Renzi, S., Limongi, AR., et al.[2021]

Increased physical activity (PA) significantly reduced systemic inflammatory cytokines in overweight and obese individuals, suggesting a potential mechanism for preventing obesity-related pancreatic ductal adenocarcinoma (PDAC).

In pre-clinical models, PA combined with dietary changes delayed weight gain and reduced PDAC incidence, indicating that lifestyle interventions may help prevent PDAC in high-risk obese individuals, although weight loss alone did not prevent tumor growth in certain models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity Delays Obesity-Associated Pancreatic Ductal Adenocarcinoma in Mice and Decreases Inflammation. Pita-Grisanti, V., Dubay, K., Lahooti, A., et al.[2023]

The systematic review of 4 prospective studies found no significant overall association between total physical activity and pancreatic cancer risk, with a summary relative risk of 0.76, indicating that higher physical activity levels do not strongly correlate with lower pancreatic cancer risk.

However, there was a notable decrease in pancreatic cancer risk associated with occupational physical activity (relative risk of 0.75), while leisure-time physical activity showed no significant effect (relative risk of 0.94), suggesting that the type of physical activity may influence cancer risk differently.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and pancreatic cancer risk: a systematic review. Bao, Y., Michaud, DS.[2018]

An updated meta-analysis of 30 studies involving 10,501 pancreatic cancer cases found a weak but statistically significant reduction in pancreatic cancer risk associated with high levels of physical activity, with a relative risk of 0.93.

The analysis suggested that consistent physical activity over time may offer a greater protective effect against pancreatic cancer (RR 0.86) compared to recent or distant past activity, although the overall association remains weak and is not influenced by smoking status or body mass index.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and risk of pancreatic cancer: a systematic review and meta-analysis. Behrens, G., Jochem, C., Schmid, D., et al.[2022]

Obesity significantly increases the risk of pancreatic cancer, with individuals having a body mass index (BMI) of 30 or higher showing more than double the risk compared to those with a normal BMI (RR 2.08).

Central weight gain is also linked to a higher risk of pancreatic cancer, with individuals reporting central adiposity having a 45% increased risk compared to those with peripheral weight gain (RR 1.45).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity, recreational physical activity, and risk of pancreatic cancer in a large U.S. Cohort. Patel, AV., Rodriguez, C., Bernstein, L., et al.[2005]

Citations

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Nutritional Interventions in Pancreatic Cancer This systematic review investigates the impact of nutritional interventions on cachexia, malnutrition and weight loss in patients with pancreatic cancer.

2. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/414907

A Combined Healthy Lifestyle Score and Risk of Pancreatic ... Results Compared with the lowest combined score (0 points), the highest score (5 points) was associated with a 58% reduction in risk of ...

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Dietary patterns and risk of pancreatic cancer - Oxford Academic Better diet quality is associated with reduced risk of pancreatic cancer. The associations between dietary patterns and pancreatic cancer were ...

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Main dietary compounds and pancreatic cancer risk. The ... The vegetables and fruit reduce the risk by 38% (95% CI = 0.54–0.73) and 29% (95% CI = 0.59–0.84), respectively.

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Diet predisposes to pancreatic cancer through cellular nutrient ... This review explores how diet influences pancreatic cancer predisposition through nutrient sensing and downstream consequences for (pre-)cancer cell biology.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28922784/

Low-fat Dietary Pattern and Pancreatic Cancer Risk ... - PubMed A low-fat dietary intervention was associated with reduced pancreatic cancer incidence in women who were overweight or obese in the WHI-DM trial.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0022316622013232

Dietary Energy Density Is Positively Associated with Risk of ... Regular consumption of energy-dense foods predisposes to obesity and type 2 diabetes, both of which are suggested risk factors for pancreatic cancer.

8. hopkinsmedicine.org hopkinsmedicine.org/health/conditions-and-diseases/pancreatic-cancer/pancreatic-cancer-nutrition

Pancreatic Cancer Nutrition: 12 Pancreatic Diet Tips Pancreatic Cancer Diet Tips · Monitor and maintain a healthy weight. · Stay hydrated. · Eat small, frequent meals. · High-protein foods with every meal. · Consider ...

9. academic.oup.com academic.oup.com/jnci/article/110/1/49/4085218

Low-fat Dietary Pattern and Pancreatic Cancer Risk in the ... A low-fat dietary intervention was associated with reduced pancreatic cancer incidence in women who were overweight or obese in the WHI-DM trial ...