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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stage III Pancreatic Cancer; Pancreatic Adenocarcinoma Non-resectable
• Intervention / Treatment: Other: Questionnaire Administration; Other: Medical Chart Review; Other: Best Practice; Other: Medical Device Usage and Evaluation; Other: Dietary Intervention; Other: Nutritional Assessment

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA / Jonsson Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Unresectable pancreatic adenocarcinoma, receiving either 1) no chemotherapy, 2) 1st cycle of chemotherapy, or 3) greater than 1 cycle of chemotherapy if the patient's prognosis is greater than 6 months as determined by oncology collaborators
• Life expectancy of greater than 3 months and a Karnofsky performance score of 60 or more
• Adults >= 18 years old male or female

Exclusion Criteria:

• Ascites requiring paracentesis for symptom improvement
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values greater than 5 times the upper limit of normal
• Creatinine value greater than 2.0 for men and 1.5 for women
• Uncontrolled pain
• Uncontrolled nausea and vomiting

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ARM I (Standard of care); Patients receive standard nutrition care and record dietary intake and physical activity using Myfitness Pal smartphone application on study.	Other: Questionnaire Administration; Ancillary studies; Other: Medical Chart Review; Ancillary studies; Other Names: Chart Review; Other: Best Practice; Receive standard nutrition care; Other Names: standard of care; standard therapy; Other: Medical Device Usage and Evaluation; Record dietary and physical activity using MyFitnessPal smartphone app
Experimental: ARM II (Dietary intervention); 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.	Other: Questionnaire Administration; Ancillary studies; Other: Medical Chart Review; Ancillary studies; Other Names: Chart Review; Other: Medical Device Usage and Evaluation; Record dietary and physical activity using MyFitnessPal smartphone app; Other: Dietary Intervention; Participate in weekly support sessions with diet prescription; Other Names: Dietary Modification; intervention, dietary; Nutrition Intervention; Nutrition Interventions; Nutritional Interventions; Other: Nutritional Assessment; Undergo malnutrition screening; Other Names: dietary counseling; Dietary Assessment; nutritional counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of hospitalizations	Hospitalization defined as any stay in the hospital > 24 hours. A two-sample t-test comparing changes from baseline in each of the outcomes between study arms used to estimate power	After 12 weeks
Length of hospital stay	Length of stay determined by the number of days of hospitalization including the date of admission and not including the day of discharge from the hospital. A two-sample t-test comparing changes from baseline in each of the outcomes between study arms used to estimate power	After 12 weeks
Percent change in body weight	Collected from patient medical record. A two-sample t-test comparing changes from baseline in each of the outcomes between study arms used to estimate power	Baseline to after 12 weeks
Average daily steps	Daily steps recorded using MyfitnessPal. A two-sample t-test comparing changes from baseline in each of the outcomes between study arms used to estimate power	After 12 weeks
Calorie intake from Myfitness Pal	Food intake collected every 4 weeks and uploaded into patients medical record via patient portal. A two-sample t-test comparing changes from baseline in each of the outcomes between study arms used to estimate power	After 12 weeks
Quality of life measured comparing changes in outcomes between study arms	Measured using short form 36. A two-sample t-test comparing changes from baseline in each of the outcomes between study arms used to estimate power	After 12 weeks
Functional status using Karnofsky performance score	The Karnofsky Performance Status (KPS) is a standardized measure used to assess a patient's ability to perform everyday tasks. It ranges from 0 to 100, with higher scores indicating better function.	After 12 weeks

Collaborators and Investigators

• Sponsor: Jonsson Comprehensive Cancer Center
• Collaborators: Silicon Valley Community Foundation
• Investigators: Principal Investigator: ZhaoPing Li, UCLA / Jonsson Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: October 13, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Therapeutics; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Quality Indicators, Health Care; Nutrition Therapy; Epidemiologic Measurements; Guidelines as Topic; Quality Assurance, Health Care; Standard of Care; Diet Therapy; Practice Guidelines as Topic; Nutrition Assessment
• Other Study ID Numbers: 22-000208; NCI-2023-01097 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No