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

NCT06090916 | Active Not Recruiting

• 2 other identifiers: 22-000208NCI-2023-01097
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stage III Pancreatic Cancer; Pancreatic Adenocarcinoma Non-resectable

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

Study Arms (2)

ARM I (Standard of care)

ACTIVE COMPARATOR

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

Other: Best Practice; Other: Medical Chart Review; Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration

ARM II (Dietary intervention)

EXPERIMENTAL

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: Dietary Intervention; Other: Medical Chart Review; Other: Medical Device Usage and Evaluation; Other: Nutritional Assessment; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Receive standard nutrition care

Also known as: standard of care, standard therapy

ARM I (Standard of care)

Dietary Intervention OTHER

Participate in weekly support sessions with diet prescription

Also known as: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions

ARM II (Dietary intervention)

Medical Chart Review OTHER

Ancillary studies

Also known as: Chart Review

ARM I (Standard of care); ARM II (Dietary intervention)

Nutritional Assessment OTHER

Undergo malnutrition screening

Also known as: Dietary Assessment, dietary counseling, nutritional counseling

ARM II (Dietary intervention)

Medical Device Usage and Evaluation OTHER

Record dietary and physical activity using MyFitnessPal smartphone app

ARM I (Standard of care); ARM II (Dietary intervention)

Questionnaire Administration OTHER

Ancillary studies

ARM I (Standard of care); ARM II (Dietary intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• Silicon Valley Community Foundation: collaborator

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; Diet Therapy; Nutrition Assessment

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Nutrition Therapy; Therapeutics; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• ZhaoPing Li

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 19, 2023
• Study Start: January 17, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: May 26, 2026

Record last verified: 2026-05

Locations

US (1)