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Spots Global Cancer Trial Database for Evaluating Weight Stability of Pancreatic Cancer Cachexia Patients

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Trial Identification

Brief Title: Evaluating Weight Stability of Pancreatic Cancer Cachexia Patients

Official Title: A Longitudinal, Single Institution Study Evaluating Weight Stability in Advanced Pancreatic Cancer Patients With Cachexia Who Are Receiving Enteral Feeding

Study ID: NCT02400398

Interventions

Tube feeding

Study Description

Brief Summary: Eligible patients will have a diagnosis of both pancreatic adenocarcinoma and cachexia defined as greater than 5% unintentional weight loss within 6 months prior to screening visit. Patients must be greater than 18 years of age; and have greater than 3 months life expectancy. This study will observe a standard of care intervention (tube feeding) for potential benefit. Peptamen will be administered through a jejunal or a gastrojejunal feeding tube and dosing will be calculated using the Mifflin St. Jeor equation. It will be administered daily for the duration of the protocol.

Detailed Description: In this study, we will prospectively evaluate advanced pancreatic adenocarcinoma patients with cachexia, who are receiving enteral feeding, with a peptide based diet (medical food), through a jejunal or gastrojejunal feeding tube. We plan to collect serum samples routinely and establish a cohort of patients with this clinical syndrome. Our aims are to establish the feasibility and efficacy of enteral nutrition and its relationship to meaningful clinical outcomes. Furthermore, we will assess for a correlation between cachexia, activity, and patient reported outcomes on domains of quality of life in an optional activity tracker sub-study.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Cedars-Sinai Medical Center, Los Angeles, California, United States

Contact Details

Name: Andrew Hendifar, MD

Affiliation: Cedars-Sinai Medical Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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