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

Jonsson Comprehensive Cancer Center

Status: Active, not recruiting

Conditions: Stage III Pancreatic Cancer; Pancreatic Adenocarcinoma Non-resectable

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06090916

22-000208

NCI-2023-01097 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

ARM I (Standard of care)

Active Comparator group

Description:

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

Treatment:

Other: Medical Chart Review

Other: Medical Device Usage and Evaluation

Other: Best Practice

Other: Questionnaire Administration

ARM II (Dietary intervention)

Experimental group

Description:

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.

Treatment:

Other: Nutritional Assessment

Other: Medical Chart Review

Other: Medical Device Usage and Evaluation

Other: Dietary Intervention

Other: Questionnaire Administration