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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tube feeding with peptide-base formula | The peptide-based formula (Peptamen) will be administered through a gastrojejunal or jejunal feeding tube and dosing will be calculated using the Mifflin St. Jeor equation. It will be administered for three 28-day cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tube feeding | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Change from baseline at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in lean body mass | Measured by Dexa Scan | Change from baseline at 3 months |
| Performance Status (ECOG) | Change from baseline at 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Pancreatic cancer patients with cachexia receiving enteral feedings by way of gastrojejunal or jejunal tube.
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Hendifar, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D002100 | Cachexia |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D004750 | Enteral Nutrition |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
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|
| Quality of Life (EORTC QLQ-C30) | Change from baseline at 3 months |
| Response to nutritional management | Assessment based on tumor biomarkers during enteral feeding period | Change from baseline at 3 months |
| Food intake assessment by 24-hour recall | Change from baseline at 3 months |
| Smell and taste alteration by questionnaire | Change from baseline at 3 months |
| Muscle strength using hand grip strength dynamometer | Change from baseline at 3 months |
| Survival | 3 years |
| Activity - steps taken | As tracked by Fitbit Charge HR biosensor | Change from baseline at 3 months |
| Activity - number of stairs | As tracked by Fitbit Charge HR biosensor | Change from baseline at 3 months |
| Activity - sleep duration and interruptions | As tracked by Fitbit Charge HR biosensor | Change from baseline at 3 months |
| Activity - heart rate | As tracked by Fitbit Charge HR biosensor | Change from baseline at 3 months |
| Changes in microbiome analysis | As measured by stool sample microbiome analysis | Change from baseline at 3 months |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |