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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-17

Study Completion Date

2027-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stage III Pancreatic Cancer Pancreatic Adenocarcinoma Non-resectable

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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ARM I (Standard of care)

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

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive standard nutrition care

Medical Chart Review

Intervention Type OTHER

Ancillary studies

Medical Device Usage and Evaluation

Intervention Type OTHER

Record dietary and physical activity using MyFitnessPal smartphone app

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

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.

Group Type EXPERIMENTAL

Dietary Intervention

Intervention Type OTHER

Participate in weekly support sessions with diet prescription

Medical Chart Review

Intervention Type OTHER

Ancillary studies

Medical Device Usage and Evaluation

Intervention Type OTHER

Record dietary and physical activity using MyFitnessPal smartphone app

Nutritional Assessment

Intervention Type OTHER

Undergo malnutrition screening

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Best Practice

Receive standard nutrition care

Intervention Type OTHER

Dietary Intervention

Participate in weekly support sessions with diet prescription

Intervention Type OTHER

Medical Chart Review

Ancillary studies

Intervention Type OTHER

Medical Device Usage and Evaluation

Record dietary and physical activity using MyFitnessPal smartphone app

Intervention Type OTHER

Nutritional Assessment

Undergo malnutrition screening

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy Dietary Modification intervention, dietary Nutrition Intervention Nutrition Interventions Nutritional Interventions Chart Review Dietary Assessment dietary counseling nutritional counseling

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No