Lifestyle Changes for Pancreatic Cancer Risk Reduction (PANTHER-PIC Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
How does the treatment of lifestyle changes for pancreatic cancer risk reduction differ from other treatments?
This treatment focuses on modifying lifestyle factors like diet and physical activity to reduce the risk of pancreatic cancer, unlike traditional treatments such as surgery or chemotherapy, which are used after the disease has developed. By addressing modifiable risk factors like obesity and physical inactivity, this approach aims to prevent the disease before it starts.
125611Is it safe for humans to participate in lifestyle changes like diet and exercise for reducing pancreatic cancer risk?
Research on diet and exercise interventions in pancreatic cancer patients shows that these lifestyle changes are generally safe, with studies focusing on adherence and adverse events during exercise programs. While the studies vary in design and outcomes, they do not report significant safety concerns for humans.
3481011What data supports the effectiveness of the treatment for reducing pancreatic cancer risk?
Research suggests that physical activity and lifestyle changes can help reduce the risk of pancreatic cancer by lowering body weight, improving insulin sensitivity (how well the body uses insulin), and decreasing inflammation. Studies have shown that consistent physical activity over time may slightly lower the risk of developing pancreatic cancer.
457911Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
Eligibility Criteria
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
My pancreatic growth is confirmed and larger than 15 mm.
I am 18 years old or older.
I am able to get out of my bed or chair and move around.
Exclusion Criteria
My condition involves high-risk pancreatic cysts or cancer.
I do not have unstable heart or lung conditions.
I have recently had a bone fracture or muscle injury.
My pain level is 7 or higher on a scale of 0 to 10.
I have a muscle or joint disease that affects my ability to move.
I have never been diagnosed with IPMN.
Participant Groups
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).
1Treatment groups
Experimental Treatment
Group I: Physical Activity (PA) and Nutrition (N)Experimental Treatment2 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.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Moffitt Cancer CenterTampa, FL
Loading ...
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
Miles for MoffittCollaborator
References
Obesity, recreational physical activity, and risk of pancreatic cancer in a large U.S. Cohort. [2005]Obesity and physical activity, in part through their effects on insulin sensitivity, may be modifiable risk factors for pancreatic cancer.
Physical activity and pancreatic cancer risk: a systematic review. [2018]Physical activity has been associated with a lower risk for pancreatic cancer in several studies, but the overall epidemiologic evidence is not consistent. We therefore did a systematic review to evaluate the association between physical activity and pancreatic cancer risk.
Physical activity, diet, and pancreatic cancer: a population-based, case-control study in Minnesota. [2022]Although mounting evidence suggests that insulin resistance is involved in pancreatic carcinogenesis, few epidemiologic studies have comprehensively investigated the role of lifestyle factors influencing this metabolic disorder in the etiology of pancreatic cancer. We sought to examine this problem in a case-control study conducted in 1994-1998 in Minnesota. Cases (n = 186), aged 20 yr or older, were ascertained from all hospitals in the metropolitan area of the Twin Cities and the Mayo Clinic; from the latter, only cases residing in the Upper Midwest of the United States were recruited. Controls (n = 554) were randomly selected from the general population and frequency matched to cases by age (within 5 yr) and sex. Odds ratios (OR) and 95% confidence intervals (95% CI) were estimated using unconditional logistic regression. After adjustment for confounders, physical activity was associated with a reduced risk, but this protective effect was confined to light activity and moderate activity only (OR = 0.55, 95% CI = 0.30-0.97, P(trend) = 0.038 and OR = 0.51, 95% CI = 0.28-0.93, P(trend) = 0.07, for highest vs. lowest quartile, respectively). An increased risk was found for dietary intakes of energy and fat but was statistically significant for saturated and polyunsaturated fat only. Of note, no appreciable difference in the magnitude of the associations existed between saturated, monounsaturated, and polyunsaturated fat. Compared with individuals in the lowest quartile of fiber intake, the risk was approximately halved for those in the third (OR = 0.49, 95% CI = 0.26-0.94) and the highest quartile (OR = 0.52, 95% CI = 0.21-1.30). Our study lends support to the hypothesis that dietary and other lifestyle factors influencing insulin resistance modulate pancreatic cancer risk.
Can physical activity modulate pancreatic cancer risk? a systematic review and meta-analysis. [2018]Numerous epidemiological studies have examined the association between physical activity and pancreatic cancer; however, findings from individual cohorts have largely not corroborated a protective effect. Among other plausible mechanisms, physical activity may reduce abdominal fat depots inducing metabolic improvements in glucose tolerance and insulin sensitivity, thereby potentially attenuating pancreatic cancer risk. We performed a systematic review to examine associations between physical activity and pancreatic cancer. Six electronic databases were searched from their inception through July 2009, including MEDLINE and EMBASE, seeking observational studies examining any physical activity measure with pancreatic cancer incidence/mortality as an outcome. A random effects model was used to pool individual effect estimates evaluating highest vs. lowest categories of activity. Twenty-eight studies were included. Pooled estimates indicated a reduction in pancreatic cancer risk with higher levels of total (five prospective studies, RR: 0.72, 95% CI: 0.52-0.99) and occupational activity (four prospective studies, RR: 0.75, 95% CI: 0.59-0.96). Nonsignificant inverse associations were seen between risks and recreational and transport physical activity. When examining exercise intensity, moderate activity appeared more protective (RR: 0.79, 95% CI: 0.52-1.20) than vigorous activity (RR: 0.97, 95% CI: 0.85-1.11), but results were not statistically significant and the former activity variable incorporated marked heterogeneity. Despite indications of an inverse relationship with higher levels of work and total activity, there was little evidence of such associations with recreational and other activity exposures.
Physical activity and risk of pancreatic cancer: a systematic review and meta-analysis. [2022]Physical activity may prevent pancreatic cancer by regulating body weight and decreasing insulin resistance, DNA damage, and chronic inflammation. Previous meta-analyses found inconsistent evidence for a protective effect of physical activity on pancreatic cancer but those studies did not investigate whether the association between physical activity and pancreatic cancer varies by smoking status, body mass index (BMI), or level of consistency of physical activity over time. To address these issues, we conducted an updated meta-analysis following the PRISMA guidelines among 30 distinct studies with a total of 10,501 pancreatic cancer cases. Random effects meta-analysis of cohort studies revealed a weak, statistically significant reduction in pancreatic cancer risk for high versus low levels of physical activity (relative risk (RR) 0.93, 95 % confidence interval (CI) 0.88-0.98). By comparison, case-control studies yielded a stronger, statistically significant risk reduction (RR 0.78, 95 % CI 0.66-0.94; p-difference by study design = 0.07). When focusing on cohort studies, physical activity summary risk estimates appeared to be more pronounced for consistent physical activity over time (RR 0.86, 95 % CI 0.76-0.97) than for recent past physical activity (RR 0.95, 95 % CI 0.90-1.01) or distant past physical activity (RR 0.95, 95 % CI 0.79-1.15, p-difference by timing in life of physical activity = 0.36). Physical activity summary risk estimates did not differ by smoking status or BMI. In conclusion, physical activity is not strongly associated with pancreatic cancer risk, and the relation is not modified by smoking status or BMI level. While overall findings were weak, we did find some suggestion of potential pancreatic cancer risk reduction with consistent physical activity over time.
A review of lifestyle and environment risk factors for pancreatic cancer. [2021]Pancreatic cancer (PaCa) is one of the deadliest cancers known and its incidence is increasing in the developed countries. Because of the lack of biomarkers that allow early detection and the tendency of the disease to be asymptomatic, the diagnosis comes often too late for effective surgical or chemotherapy intervention. Lifestyle factors, that may cause common genetic modifications occurring in the disease, interfere with pancreatic physiology or function, and play a role in PaCa development, have been of concern recently, since a strategy to prevent this severe cancer is needed. This review identifies the latest evidences related to increased risk of developing PaCa due to dietary habits such as high alcohol, fructose and red or processed meat intake, and pathological conditions such as diabetes, obesity and infections in addition to stress and smoking behaviour. It aims to highlight the importance of intervening on modifiable risk factors: the action on these factors could prevent a considerable number of new cases of PaCa.
Multidisciplinary lifestyle intervention to manage pancreatic cancer-related cachexia: a case report. [2023]Pancreatic cancer remains an aggressive disease, with a poor prognosis and a high risk of incurring into cachexia. Supportive care, such as exercise, nutritional and psychological support, may be effective in reducing functional loss, psychological distress and improving nutritional status. We report the effect of 12 weeks of multimodal lifestyle intervention in a 55-year-old female, diagnosed with unresectable body/tail pancreatic cancer and metastasis in the liver, bone, lymph node and lung, to counteract cachexia. The multimodal program resulted safe and feasible. Over 12 weeks, considerable improvements were found in body weight, health-related physical fitness, nutritional status, distress scores, anxiety and depression levels. These findings highlight the potential role of integrated supportive interventions to manage metastatic cancer and cancer-induced cachexia.
Diet and Exercise Interventions in Patients With Pancreatic Cancer: A Scoping Review. [2022]Diet and exercise interventions may help reverse malnutrition and muscle wasting common in pancreatic cancer. We performed a scoping review to identify the knowledge gaps surrounding diet and exercise interventions. We searched PubMed, Scopus, Cumulative Index to Nursing and Allied Health Literature, Embase, ProQuest Theses and Dissertations, and Google Scholar using the umbrella terms of "pancreatic cancer," "diet/nutrition," and "exercise." Included were articles reporting on ambulatory adults with diagnosed pancreatic cancer. Excluded were studies examining prevention and/or risk, animal, or cell lines. Of the 15,708 articles identified, only 62 met the final inclusion criteria. Almost half of the articles were randomized controlled studies (n = 27). Most studies were from the United States (n = 20). The majority examined dietary interventions (n = 41), with 20 assessing the use of omega-3 fatty acids. Exercise interventions were reported in 13 studies, with 8 examining a diet and exercise intervention. Most studies were small and varied greatly in terms of study design, intervention, and outcomes. We identified 7 research gaps that should be addressed in future studies. This scoping review highlights the limited research examining the effect of diet and exercise interventions in ambulatory patients with pancreatic cancer.
Effect of exercise on pancreatic cancer patients during treatment: a scoping review of the literature. [2023]Exercise can lower the risk of developing pancreatic cancer and has the potential to improve physical fitness and quality of life in patients with the disease. Yet, the effects of exercise training during pancreatic cancer treatment remain poorly characterized. This hampers the development of evidence-based disease-specific exercise recommendations.
Evaluation of a Clinic-Based Exercise Program in Patients with Pancreatic Cancer Undergoing Nonsurgical Treatment. [2023]Evidence regarding the role of exercise in pancreatic cancer (PanCa) is limited and is derived exclusively under tightly controlled research conditions. This study aimed to quantify adherence, adverse events, and changes in physical and psychological outcomes in any patients with PanCa referred to undertake exercise during nonsurgical treatment.
Physical Activity Delays Obesity-Associated Pancreatic Ductal Adenocarcinoma in Mice and Decreases Inflammation. [2023]Obesity is a risk factor for pancreatic ductal adenocarcinoma (PDAC), a deadly disease with limited preventive strategies. Lifestyle interventions to decrease obesity might prevent obesity-associated PDAC. Here, we examined whether decreasing obesity by increased physical activity (PA) and/or dietary changes would decrease inflammation in humans and prevent PDAC in mice.