Evaluating an Amino Acid Based Medical Food w/ Diarrhea in Carcinoid Syndrome & Other NETs

Summary

Participation Requirements

Description

This prospective, phase 2 study is to assess how Enterade® will affect patient-reported quality of life and intestinal absorption in patients with Carcinoid Syndrome and Neuroendocrine Tumors. The hypothesis is that Enterade® when combined with standard supportive care will improve patient-reported ...

This prospective, phase 2 study is to assess how Enterade® will affect patient-reported quality of life and intestinal absorption in patients with Carcinoid Syndrome and Neuroendocrine Tumors. The hypothesis is that Enterade® when combined with standard supportive care will improve patient-reported quality of life and help maintain the small bowel's ability to absorb and retain fluids, possibly leading to a reduction in diarrhea frequency. This is a non-randomized, supportive-care study. Potentially eligible patients will be screened in the University of Kentucky Markey Cancer Center clinics. During the screening visit, immediately after signing informed consent, the participant will be given both flavors of enterade® (original vanilla and refreshing orange) to test tolerability and taste. Eligible subjects will be given a stool diary and will be asked to document daily stool output (frequency and consistency of stool), use of anti-diarrheal medication and gastrointestinal discomforts (bloating, cramping). All lab and screening tests should be completed within 2 weeks prior to registration/initiation of study. The study is broken into 3 distinct segments and will apply to all enrolled participants: Baseline observation (Weeks 1-4), Enterade® administration period (4 weeks), Post-Enterade® Period (4 weeks). After relapse of diarrhea is documented or the 4 weeks of post-Enterade® observation are completed (whatever happens first), participants will be given the option to restart Enterade® for 1 additional month.

Tracking Information