Pancreatic Adenocarcinoma Non-resectable, Stage III Pancreatic Cancer
Conditions
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.
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.
Interventions
OTHERBest Practice
Receive standard nutrition care
OTHERDietary Intervention
Participate in weekly support sessions with diet prescription
OTHERMedical Chart Review
Ancillary studies
OTHERMedical Device Usage and Evaluation
Record dietary and physical activity using MyFitnessPal smartphone app
OTHERNutritional Assessment
Undergo malnutrition screening
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
Jonsson Comprehensive Cancer Center
Silicon Valley Community Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life measured comparing changes in outcomes between study arms | 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 | 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. |
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORZhaoPing Li
UCLA / Jonsson Comprehensive Cancer Center
Outcome results
None listed