Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
NCT Number: NCT02400398
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Los Angeles, California, 90048, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Jejunal or gastrojejunal tube feeds will be given as continuous feeds via pump with Peptamen (medical food), at the patient's home, for the duration of the protocol and as directed by the nutritionist.
Other names: Enteral feeding, Jejunal tube, Gastrojejunal tube
Time frame: Change from baseline at 3 months
Time frame: Change from baseline at 3 months
Measured by Dexa Scan
Time frame: Change from baseline at 3 months
Time frame: Change from baseline at 3 months
Time frame: Change from baseline at 3 months
Assessment based on tumor biomarkers during enteral feeding period
Time frame: Change from baseline at 3 months
Time frame: Change from baseline at 3 months
Time frame: Change from baseline at 3 months
Time frame: 3 years
Time frame: Change from baseline at 3 months
As tracked by Fitbit Charge HR biosensor
Time frame: Change from baseline at 3 months
As tracked by Fitbit Charge HR biosensor
Time frame: Change from baseline at 3 months
As tracked by Fitbit Charge HR biosensor
Time frame: Change from baseline at 3 months
As tracked by Fitbit Charge HR biosensor
Time frame: Change from baseline at 3 months
As measured by stool sample microbiome analysis
Andrew Hendifar, MD
Other
A Longitudinal, Single Institution Study Evaluating Weight Stability in Advanced Pancreatic Cancer Patients With Cachexia Who Are Receiving Enteral Feeding
Acronym: PanCax
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02381249
Body Weight, Body Weight Changes
Dublin, Ireland
View Trial DetailsNCT02500004
Body Weight, Body Weight Changes
Maastricht, Netherlands
View Trial DetailsNCT00060502
Anemia, Anorexia
View Trial DetailsNCT05351983
Digestive System Diseases, Digestive System Neoplasms
Zurich, Canton of Zurich, Switzerland
View Trial Details