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Evaluating Weight Stability of Pancreatic Cancer Cachexia Patients (PanCax)

Purpose 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 overnight for the duration of the protocol.
Recruitment This study is currently recruiting participants.
Condition Pancreatic Neoplasms
Pancreatic Cancer
Cachexia
Weight Loss
Intervention Other: Tube feeding
Outcome Measures
Primary Outcome Measures:
  • Weight [ Time Frame: Change from baseline at 3 months ] [ Designated as safety issue: No ].
Secondary Outcome Measures:
  • Performance Status (ECOG) [ Time Frame: Change from baseline at 3 months ] [ Designated as safety issue: No ]
  • Quality of Life (EORTC QLQ-C30) [ Time Frame: Change from baseline at 3 months ] [ Designated as safety issue: No ]
  • Response to nutritional management [ Time Frame: Change from baseline at 3 months ] [ Designated as safety issue: No ]
    Assessment based on tumor biomarkers during enteral feeding period
  • Food intake assessment by 24-hour recall [ Time Frame: Change from baseline at 3 months ] [ Designated as safety issue: No ]
  • Smell and taste alteration by questionnaire [ Time Frame: Change from baseline at 3 months ] [ Designated as safety issue: No ]
  • Muscle strength using hand grip strength dynamometer [ Time Frame: Change from baseline at 3 months ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Activity [ Time Frame: Change from baseline at 3 months ] [ Designated as safety issue: No ]
    (steps taken, number of stairs, sleep duration and interruptions, heart rate)
Locations and Contacts
Contacts
Miranda Bryant; 310-248-6735 Miranda.Bryant@cshs.org

Locations

United States, California
Cedars-Sinai Medical Center - Recruiting
Los Angeles, California, United States, 90048
More Info https://clinicaltrials.gov/ct2/show/NCT02400398

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