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Trial Title:
Malnutrition Screening and Dietary Intervention to Improve Nutrition Outcomes in Patients With Unresectable Pancreatic Cancer
NCT ID:
NCT06090916
Condition:
Stage III Pancreatic Cancer
Pancreatic Adenocarcinoma Non-resectable
Conditions: Official terms:
Pancreatic Neoplasms
Malnutrition
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Best Practice
Description:
Receive standard nutrition care
Arm group label:
ARM I (Standard of care)
Other name:
standard of care
Other name:
standard therapy
Intervention type:
Other
Intervention name:
Dietary Intervention
Description:
Participate in weekly support sessions with diet prescription
Arm group label:
ARM II (Dietary intervention)
Other name:
Dietary Modification
Other name:
intervention, dietary
Other name:
Nutrition Intervention
Other name:
Nutrition Interventions
Other name:
Nutritional Interventions
Intervention type:
Other
Intervention name:
Medical Chart Review
Description:
Ancillary studies
Arm group label:
ARM I (Standard of care)
Arm group label:
ARM II (Dietary intervention)
Other name:
Chart Review
Intervention type:
Other
Intervention name:
Medical Device Usage and Evaluation
Description:
Record dietary and physical activity using MyFitnessPal smartphone app
Arm group label:
ARM I (Standard of care)
Arm group label:
ARM II (Dietary intervention)
Intervention type:
Other
Intervention name:
Nutritional Assessment
Description:
Undergo malnutrition screening
Arm group label:
ARM II (Dietary intervention)
Other name:
Dietary Assessment
Other name:
dietary counseling
Other name:
nutritional counseling
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
ARM I (Standard of care)
Arm group label:
ARM II (Dietary intervention)
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UCLA / Jonsson Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Contact:
Last name:
Zhaoping Li
Phone:
310-206-1987
Email:
zli@mednet.ucla.edu
Investigator:
Last name:
Zhaoping Li
Email:
Principal Investigator
Start date:
January 17, 2023
Completion date:
January 31, 2026
Lead sponsor:
Agency:
Jonsson Comprehensive Cancer Center
Agency class:
Other
Collaborator:
Agency:
Silicon Valley Community Foundation
Agency class:
Other
Source:
Jonsson Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06090916
