Enterade in Improving Quality of Life in Patients with Diarrhea due to Neuroendocrine Tumors

PRIMARY OBJECTIVE:

I. To assess how an amino acid based medical food (enterade) (amino acid/electrolyte mixture-based dietary supplement) helps maintain the intestine’s ability to absorb and retain fluids, leading to a reduction in diarrhea due to neuroendocrine tumors.

SECONDARY OBJECTIVES:

I. To assess subject reported health-related quality of life in subjects before and after compound administration. (Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea [FACIT-D], Version 4).

II. To characterize the side effect profile and tolerability of enterade as measured by the number of total 8-oz enterade bottles consumed throughout the trial, and average drinks per day.

III. To evaluate changes in serum electrolytes before and after administration of enterade.

IV. To assess intravenous fluid requirement and/or hospitalization for dehydration secondary to diarrhea between control observation period and active enterade period.

V. To evaluate difference in utilization of standard-of-care anti-diarrheal medications between control observation period and enterade period.

VI. To compare subjective feeling of bloating and flatulence before and after administration of enterade.

VII. To evaluate changes in patient weight before and after administration of enterade.

EXPLORATORY OBJECTIVES:

I. To assess any change or difference in plasma and stool inflammatory markers to determine intestinal health (IL-1beta, IL-6 and TNF-alpha and plasma endotoxin) before and after enterade.

II. To evaluate fecal lactoferrin in study cohorts.

OUTLINE:

Patients receive amino acid/electrolyte mixture-based dietary supplement orally (PO) twice daily (BID) on days 1-28 of weeks 5-8 following baseline observation period. Patients are also instructed to document stool output, daily consumption, and symptoms using a diary.

After completion of study, patients are followed up per their treating oncologist’s discretion.