Evaluating an Amino Acid Based Medical Food w/ Diarrhea in Carcinoid Syndrome & Other NETs
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Irritable Bowel Syndrome (IBS), Brain Cancer, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/22/2018 |
| Start Date: | December 6, 2018 |
| End Date: | August 2030 |
| Contact: | Cynthia Leedham, PhD |
| Email: | cleed2@email.uky.edu |
| Phone: | 859-257-4470 |
A Phase 2 Study Evaluating a Proprietary Amino Acid Based Medical Food (Enterade®) in Patients With Quality of Life Limiting Diarrhea Due to Carcinoid Syndrome and Other Neuroendocrine Tumors (NET).
Primary Objective:
To assess how an amino acid based medical food (Enterade®) helps maintain the intestine's
ability to absorb and retain fluids, leading to a reduction in diarrhea due to Neuroendocrine
Tumors (NET) and/or Carcinoid Syndrome. This improvement in the absorption will be assessed
in part by evaluating changes in average daily stool frequency from baseline in patients
receiving Enterade®. Each subject serves as his or her own control.
Secondary Objectives:
- To assess subject reported health-related quality of life in subjects before and after
compound administration.
- 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.
- To evaluate changes in serum electrolytes before and after administration of Eenterade®.
- To assess intravenous fluid requirement and/or hospitalization for dehydration secondary
to diarrhea between control observation period and active Enterade® period.
- To evaluate difference in utilization of standard-of-care anti-diarrheal medications
between control observation period and Enterade® period.
- To compare subjective feeling of bloating and flatulence before and after administration
of Enterade®.
- To evaluate changes in patient weight before and after administration of Enterade®.
To assess how an amino acid based medical food (Enterade®) helps maintain the intestine's
ability to absorb and retain fluids, leading to a reduction in diarrhea due to Neuroendocrine
Tumors (NET) and/or Carcinoid Syndrome. This improvement in the absorption will be assessed
in part by evaluating changes in average daily stool frequency from baseline in patients
receiving Enterade®. Each subject serves as his or her own control.
Secondary Objectives:
- To assess subject reported health-related quality of life in subjects before and after
compound administration.
- 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.
- To evaluate changes in serum electrolytes before and after administration of Eenterade®.
- To assess intravenous fluid requirement and/or hospitalization for dehydration secondary
to diarrhea between control observation period and active Enterade® period.
- To evaluate difference in utilization of standard-of-care anti-diarrheal medications
between control observation period and Enterade® period.
- To compare subjective feeling of bloating and flatulence before and after administration
of Enterade®.
- To evaluate changes in patient weight before and after administration of Enterade®.
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.
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.
Inclusion Criteria:
- Cohort 1: Participants must have histopathologically confirmed neuroendocrine tumor
with 4 or more bowel movements per day on standard anti-diarrheal regimen (which may
or may not include somatostatin analogs and telotristat), AND an elevated serum
serotonin or plasma serotonin above the upper limit of normal per reference lab.
- Cohort 2: Participants who have histopathologically confirmed neuroendocrine tumor and
have 4 or more bowel movements per day on standard anti-diarrheal regimen (which may
or may not include somatostatin analogs and telotristat), but are below the cut-point
for serotonin elevation.
- Age equal to or greater than 18 years old.
- ECOG performance status ≤2 (Karnofsky ≥60%)
- Ability to tolerate thin liquids by mouth at the time of enrollment.
- Ability to understand and the willingness to sign a written informed consent document.
- Subject who are willing to take enterade® as instructed will be eligible.
Exclusion Criteria:
- Known allergy to Stevia.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
Clostridium difficile infection or history of Clostridium difficile infection.
- Participants with active clostridium difficile infection will be ineligible for this
study.
- Participants with a history of inflammatory bowel disease, irritable bowel syndrome,
bariatric surgery and/or Celiac disease.
- Participants with psychiatric illness/social situations that would limit compliance
with study requirements.
- Patients who have had enterade® within the past 12 months.
We found this trial at
1
site
Lexington, Kentucky
Principal Investigator: Lowell Anthony, MD
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