Dietary Intervention for Pancreatic Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jonsson Comprehensive Cancer Center

Disqualifiers: Ascites, High AST/ALT, High creatinine, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 15

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special diet plan can improve the quality of life for individuals with pancreatic cancer that cannot be surgically removed. Researchers aim to determine if screening for poor nutrition and providing weekly diet support can alleviate common symptoms such as pain, nausea, and weight loss. One group will receive personalized diet advice (dietary intervention), while another will receive standard nutrition care. Individuals with pancreatic cancer who are not undergoing surgery and are either starting or continuing chemotherapy may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to enhance understanding of how dietary interventions can support cancer patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this dietary intervention is safe for patients with pancreatic cancer?

Studies have shown that nutritional plans can be safe and helpful for people with pancreatic cancer. Research indicates that a well-organized nutritional support program can improve patients' health, especially for those receiving treatments like chemotherapy. This program helps patients maintain or gain weight and improve their nutrition, which is crucial because many people with pancreatic cancer lose weight and become malnourished.

One review found that personalized diet plans and regular nutritional support can help manage symptoms like pain and nausea. These approaches focus on improving quality of life, a major concern for patients with advanced pancreatic cancer. Importantly, these dietary plans are safe and aim to support patients' overall health and well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this dietary intervention for pancreatic cancer because it offers a personalized approach to nutrition, which is not typically part of the standard care. Unlike traditional treatments that focus primarily on medical and surgical options, this intervention tailors diet plans to individual patients' nutritional needs, especially those at risk of malnutrition. This personalized diet plan, combined with regular support sessions and the use of the MyFitnessPal app to track progress, aims to improve patients' nutritional status and overall quality of life. This innovative approach could complement standard treatments and potentially improve outcomes for pancreatic cancer patients.

What evidence suggests that this dietary intervention is effective for improving quality of life in patients with unresectable pancreatic cancer?

Research shows that nutritional support can aid weight loss, address malnutrition, and improve the quality of life for people with pancreatic cancer. Studies have found that about 80% of these patients lose weight at diagnosis, and many become malnourished during treatment. Nutritional support effectively addresses these issues. In this trial, participants in the dietary intervention arm will undergo malnutrition screening and receive personalized meal plans to manage these challenges. Early supportive care, including nutrition, links to better overall outcomes for those with pancreatic cancer. ^{2 6 7 8 9}

Who Is on the Research Team?

Zhaoping Li

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with unresectable pancreatic cancer, who are either not on chemotherapy, starting their first cycle, or have been through more than one cycle but still have a life expectancy of over 6 months. They should be able to perform daily activities (Karnofsky score ≥60) and live longer than 3 months.

Inclusion Criteria

I have pancreatic cancer that cannot be removed by surgery and am either not on chemotherapy, in my first cycle, or have been on it longer but expected to live more than 6 months.

I am expected to live more than 3 months and can care for myself with some assistance.

Exclusion Criteria

I need a procedure to remove fluid from my abdomen to relieve symptoms.

Your AST or ALT levels are more than 5 times the normal limit.

I frequently experience severe nausea and vomiting that is not managed by medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Dietary Intervention

Participants undergo malnutrition screening and participate in 12 weekly nutrition support sessions, with personalized diet prescriptions for those at moderate to high risk

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for changes in quality of life, hospitalization frequency, functional status, and dietary intake

4 weeks

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Dietary Intervention

Trial Overview The study tests if screening patients for malnutrition and providing dietary support improves quality of life compared to standard care. It involves best practices in nutrition, medical chart reviews, questionnaires, using medical devices to assess nutrition status, and tailored dietary interventions.

How Is the Trial Designed?

Group I: ARM II (Dietary intervention) Experimental Treatment 5 Interventions

Patients undergo malnutrition screening with a registered dietician at baseline and participate in 12 weekly nutrition support sessions and those at moderate to high risk for malnutrition receive a personalized diet prescription on study. Patients also record dietary intake and physical activity using Myfitness Pal smartphone application on study.

Group II: ARM I (Standard of care) Active Control 4 Interventions

Patients receive standard nutrition care and record dietary intake and physical activity using Myfitness Pal smartphone application on study.

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

Silicon Valley Community Foundation

Collaborator

Trials

6

Recruited

1,300+

Silicon Valley Community Foundation

Collaborator

Trials

6

Recruited

1,300+

Published Research Related to This Trial

Cigarette smoking, diabetes history, and obesity are significant modifiable risk factors for pancreatic cancer, which has a very high mortality rate shortly after diagnosis.

To better understand the causes of pancreatic cancer, future research should focus on using biological samples from participants, as current dietary questionnaires may not accurately capture nutrient bioavailability and individual metabolic differences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and pancreatic cancer: many questions with few certainties. Cappellani, A., Cavallaro, A., Di Vita, M., et al.[2013]

In a study of 97 patients with pancreatic adenocarcinoma, systematic malnutrition screening revealed that 74.2% requested referrals to an oncology dietitian, highlighting the need for proactive nutrition interventions.

Attendance at pre-clinic information sessions significantly increased the likelihood of patients requesting referrals and attending dietitian appointments, suggesting that educational initiatives can enhance patient engagement with nutrition services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of the nutrition referral system in a multidisciplinary pancreatic cancer clinic. Wong, SC., Reddy, AV., Hacker-Prietz, A., et al.[2023]

Pancreatic cancer has a very low 5-year survival rate of only 4%, making it a critical area for research into prevention and treatment strategies.

This review highlights the potential of dietary factors, such as citrus fruits, flavonoids, curcumin, folate, and vitamin D, in influencing the risk of developing pancreatic cancer and suggests that these food-based approaches could serve as innovative therapies for prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary factors and pancreatic cancer: the role of food bioactive compounds. Johnson, J., de Mejia, EG.[2016]

A survey of 26 hepatopancreatobiliary (HPB) units in the UK revealed that while 88.5% provide a specialist dietetic service, practices for nutritional management in pancreatic cancer patients are inconsistent, highlighting a need for standardized guidelines.

Only 50% of units routinely perform nutrition risk screening, and there is significant variability in the use of nutritional supplements and pancreatic exocrine replacement therapy (PERT), indicating that more robust studies are necessary to establish effective consensus practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results from a UK-wide survey: the nutritional assessment and management of pancreatic resection patients is highly variable. Russell, TB., Murphy, P., Tanase, A., et al.[2022]

Patients with pancreatic cancer who develop irreversible cachexia have a very short life expectancy of less than 3 months, highlighting the urgent need for early nutritional assessment and intervention.

Nutritional counseling and pancreatic enzyme replacement therapy are essential components of nutritional treatment, helping to alleviate symptoms and improve the nutritional status of patients undergoing various treatments for pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Nutritional Status and the Impact of Nutritional Treatment in Patients with Pancreatic Cancer. Mękal, D., Sobocki, J., Badowska-Kozakiewicz, A., et al.[2023]

Smoking is a major risk factor for pancreatic cancer, accounting for 19% of all cases, while nutrition and food consumption patterns contribute to 35% of cases, highlighting the importance of lifestyle choices in cancer risk.

Epidemiological studies show that high intakes of meat, carbohydrates, and dietary cholesterol are positively associated with pancreatic cancer, whereas higher consumption of fruits, vegetables, fiber, and vitamin C is inversely related to the disease risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Advances in researches on genetic epidemiology of pancreatic cancer]. Wang, L., Li, H.[2006]

A multidisciplinary approach combining chemotherapy with close nutritional support can improve disease control and extend survival in patients with pancreatic adenocarcinoma, which typically has a poor prognosis.

Nutritional interventions have been shown to enhance quality of life and survival rates in patients suffering from anorexia and muscle mass loss due to the disease and its treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omega-3 therapeutic supplementation in a patient with metastatic adenocarcinoma of the pancreas with muscle mass depletion. Ramalho, R., Ramalho, P., Couto, N., et al.[2023]

In a study of 304 pancreatic cancer patients, 70% maintained or improved their nutritional status during treatment, which is crucial for their overall health.

Improvement in nutritional status, as measured by the Subjective Global Assessment (SGA), was linked to a significantly lower risk of mortality, with patients showing improved SGA having a 1.5 times lower risk of death compared to those with deteriorated SGA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of systematic nutritional assessment and medical nutrition therapy in pancreatic cancer. Vashi, P., Popiel, B., Lammersfeld, C., et al.[2015]

A study involving 384 pancreatic cancer cases and 983 controls found that higher intake of certain nutrients from fruits and vegetables, such as magnesium, potassium, and vitamins, is associated with a reduced risk of pancreatic cancer.

The relationship between these nutrients and pancreatic cancer risk was dose-dependent, suggesting that greater consumption of these nutrients may further lower the risk of developing the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrients from fruit and vegetable consumption reduce the risk of pancreatic cancer. Jansen, RJ., Robinson, DP., Stolzenberg-Solomon, RZ., et al.[2022]

In a study of 109 patients with pancreatic ductal adenocarcinoma (PDAC), 64.2% were found to be at high risk of malnutrition, highlighting the importance of nutritional assessment in this population.

Early nutritional intervention within 3 months of diagnosis was associated with significant benefits, including a 2-year overall survival rate of 50.3% for those who gained weight, compared to 33.0% for those who did not, suggesting that timely dietary support can improve outcomes in patients undergoing chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic impact of early nutritional support in patients affected by locally advanced and metastatic pancreatic ductal adenocarcinoma undergoing chemotherapy. Trestini, I., Carbognin, L., Sperduti, I., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9101959/

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10417457/

Evaluation of Nutritional Status and the Impact of ... Approximately 80% of PC patients report weight loss at diagnosis, and 70.3% of patients develop malnutrition during chemotherapy (CT). Early diagnosis of ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06090916

Malnutrition Screening and Dietary Intervention to Improve ... This clinical trial compares the effect of malnutrition screening and dietary intervention to standard nutrition care on patients with pancreatic cancer ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0885392425007602

Early supportive and nutritional care for adults with ... Quality of life for individuals with pancreatic cancer is highly influenced by symptom burden and nutritional status. Programs are needed that ...

5. link.springer.com link.springer.com/article/10.1007/s00520-024-08683-0

Nutritional support in pancreatic cancer patients and its ... This study evaluated the effectiveness of current practice in nutritional support for patients with pancreatic cancer.

6. mdpi.com mdpi.com/2072-6694/15/15/3816

Evaluation of Nutritional Status and the Impact ... Approximately 80% of PC patients report weight loss at diagnosis, and 70.3% of patients develop malnutrition during chemotherapy (CT). Early diagnosis of ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40816695/

Early Supportive and Nutritional Care For Adults With ... Quality of life for individuals with pancreatic cancer is highly influenced by symptom burden and nutritional status. Programs are needed that ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2161831323002636

Dietary Factors and Pancreatic Cancer Risk: An Umbrella ... This umbrella review found that regular consumption of nuts and reduced intake of fructose, red meat, and alcohol were associated with a lower risk of ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT07057843

Sequential Nutrition Intervention for Pancreatic Cancer ... This study aims to evaluate the clinical value of a structured nutritional support program for patients with pancreatic cancer undergoing ...