NCT06090916

Malnutrition Screening and Dietary Intervention to Improve Nutrition Outcomes in Patients With Unresectable Pancreatic Cancer

Malnutrition Screening and Nutrition Optimization to Improve Outcomes in Patients With Unresectable Pancreatic Cancer

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial compares the effect of malnutrition screening and dietary intervention to standard nutrition care on patients with pancreatic cancer that cannot be removed by surgery (unresectable). Fewer than 20% of patients diagnosed with unresectable pancreatic cancer do not survive one year after diagnosis so treatment often focuses on improving quality of life. Many patients experience increasing pain, nausea, vomiting, loss of appetite, weight loss and weakness. Behavioral interventions use techniques to help patients change the way they react to environmental triggers that may cause a negative reaction. Screening for inadequate nutrition (malnutrition) and providing weekly nutritional support may be effective methods to improve nutritional status and improve overall quality of life for patients with unresectable pancreatic cancer.

Detailed description

PRIMARY OBJECTIVES: I. To compare the quality of life of subjects after 12 weeks between the intervention group with nutrition optimization with dietary prescription and nutrition support in comparison to standard care. II. To compare the frequency of hospitalization and length of stay (LOS) after 12 weeks between the intervention group with nutrition optimization with dietary prescription and nutrition support in comparison to standard care. III. To compare the subject's functional status, body weight and dietary intake after 12 weeks between the intervention group with nutrition optimization with dietary prescription and nutrition support in comparison to standard care. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive standard nutrition care and record dietary intake and physical activity using Myfitness Pal smartphone application on study. ARM II: 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.

Conditions

• Stage III Pancreatic Cancer
• Pancreatic Adenocarcinoma Non-resectable

Interventions

Type	Name	Description
OTHER	Best Practice	Receive standard nutrition care
OTHER	Dietary Intervention	Participate in weekly support sessions with diet prescription
OTHER	Medical Chart Review	Ancillary studies
OTHER	Medical Device Usage and Evaluation	Record dietary and physical activity using MyFitnessPal smartphone app
OTHER	Nutritional Assessment	Undergo malnutrition screening
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2023-01-17
• Primary completion: 2026-03-31
• Completion: 2027-03-31
• First posted: 2023-10-19
• Last updated: 2025-05-13

Locations

1 site across 1 country: United States