Malnutrition Screening and Dietary Intervention to Improve Nutrition Outcomes in Patients With Unresectable Pancreatic Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
PRIMARY OBJECTIVES:
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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.
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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.
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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 Design
Arms and Interventions
| 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: Best Practice
Receive standard nutrition care
Other Names:
Other: Medical Chart Review
Ancillary studies
Other Names:
Other: Medical Device Usage and Evaluation
Record dietary and physical activity using MyFitnessPal smartphone app
Other: Questionnaire Administration
Ancillary studies
|
| 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: Dietary Intervention
Participate in weekly support sessions with diet prescription
Other Names:
Other: Medical Chart Review
Ancillary studies
Other Names:
Other: Medical Device Usage and Evaluation
Record dietary and physical activity using MyFitnessPal smartphone app
Other: Nutritional Assessment
Undergo malnutrition screening
Other Names:
Other: Questionnaire Administration
Ancillary studies
|
Outcome Measures
Primary Outcome Measures
- Quality of life [After 12 weeks]
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
- Frequency of hospitalizations [After 12 weeks]
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
- Length of hospital stay [After 12 weeks]
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
- Functional status using Karnofsky performance score [After 12 weeks]
All activity recorded using MyfitnessPal. A two-sample t-test comparing changes from baseline in each of the outcomes between study arms used to estimate power
- Percent change in body weight [Baseline to after 12 weeks]
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
- Average daily steps [After 12 weeks]
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
- Calorie intake from Myfitness Pal [After 12 weeks]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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Life expectancy of greater than 3 months and a Karnofsky performance score of 60 or more
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Adults >= 18 years old male or female
Exclusion Criteria:
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Ascites requiring paracentesis for symptom improvement
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Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values greater than 5 times the upper limit of normal
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Creatinine value greater than 2.0 for men and 1.5 for women
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Uncontrolled pain
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Uncontrolled nausea and vomiting
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | United States | 90095 |
Sponsors and Collaborators
- Jonsson Comprehensive Cancer Center
- Silicon Valley Community Foundation
Investigators
- Principal Investigator: ZhaoPing Li, UCLA / Jonsson Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22-000208
- NCI-2023-01097