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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial involves checking for poor nutrition and providing personalized diet plans and regular support to patients with pancreatic cancer that cannot be surgically removed. The goal is to improve their quality of life by ensuring they get the right nutrients.

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 data supports the effectiveness of the treatment Dietary Intervention, Nutritional Counseling, Dietary Therapy for pancreatic cancer?

Research shows that nutritional support, including dietary interventions and counseling, can improve outcomes for pancreatic cancer patients by reducing weight and muscle loss, which are common issues that affect treatment success and survival. ^{1 2 3 4 5}

Is dietary intervention safe for humans?

The research does not provide specific safety data for dietary interventions, but it suggests that nutrients from fruits and vegetables may reduce the risk of pancreatic cancer, indicating potential safety and benefits. ^{3 6 7 8 9}

How does the dietary intervention treatment for pancreatic cancer differ from other treatments?

This dietary intervention for pancreatic cancer is unique because it focuses on using food-based approaches, such as citrus fruits and foods rich in flavonoids, curcumin, folate, and vitamin D, to potentially prevent the disease. Unlike traditional treatments, this approach emphasizes the role of nutrition and specific dietary components in managing and possibly reducing the risk of pancreatic cancer. ^{2 3 4 9 10}

Research Team

Zhaoping Li

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Effectiveness of the nutrition referral system in a multidisciplinary pancreatic cancer clinic. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Outcomes of systematic nutritional assessment and medical nutrition therapy in pancreatic cancer. [2015]

3. England pubmed.ncbi.nlm.nih.gov

Prognostic impact of early nutritional support in patients affected by locally advanced and metastatic pancreatic ductal adenocarcinoma undergoing chemotherapy. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Omega-3 therapeutic supplementation in a patient with metastatic adenocarcinoma of the pancreas with muscle mass depletion. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of Nutritional Status and the Impact of Nutritional Treatment in Patients with Pancreatic Cancer. [2023]

6. China pubmed.ncbi.nlm.nih.gov

[Advances in researches on genetic epidemiology of pancreatic cancer]. [2006]

7. Italy pubmed.ncbi.nlm.nih.gov

Diet and pancreatic cancer: many questions with few certainties. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Nutrients from fruit and vegetable consumption reduce the risk of pancreatic cancer. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Dietary factors and pancreatic cancer: the role of food bioactive compounds. [2016]

10. England pubmed.ncbi.nlm.nih.gov

Results from a UK-wide survey: the nutritional assessment and management of pancreatic resection patients is highly variable. [2022]