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A Medical Food (Enterade) for the Reduction of Bowel Movement Frequency in Patients with Carcinoid Syndrome or Non-Carcinoid Syndrome Neuroendocrine Tumor

Trial Status: Active

This phase II trial studies how well a medical food called enterade works in reducing bowel movement frequency in patients with carcinoid syndrome or non-carcinoid syndrome neuroendocrine tumor. Enterade is a commercially available amino acid-based medical food being developed to manage diarrhea due to carcinoid syndrome or other neuroendocrine tumors. It may also alleviate abdominal pain or discomfort, bloating, cramping and gas secondary to the disease. Enterade may alleviate neuroendocrine tumor associated diarrhea, provide control of bowel-related symptoms, and improve quality of life in neuroendocrine tumor patients with diarrhea.

Inclusion Criteria

  • Cohort 1 (carcinoid syndrome): Participants must have histopathologically confirmed neuroendocrine tumor with 4 or more bowel movements per day on standard anti-diarrheal regimen (which includes somatostatin analogs), AND a plasma 5-HIAA, urine 24-hour 5-HIAA or plasma secretory hormone levels (VIP, gastrin) above the upper limit of normal per reference laboratory (lab)
  • Cohort 2 (non-carcinoid syndrome): 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), but do not have elevated plasma 5-HIAA, 24-hour urine 5-HIAA or other plasma secretory hormone levels (VIP, gastrin) above the upper limit of normal per reference lab
  • Eastern Cooperative Oncology Group (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 recent history of Clostridium difficile infection (within the past 90 days)
  • 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 45 days
  • Pregnant or breastfeeding women. The safety of enterade has not been validated in this patient population

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: ACTIVE
Contact: Satya Das
Phone: 615-936-8422

PRIMARY OBJECTIVE:

I. To assess the ability of amino acid/electrolyte mixture-based dietary supplement (enterade) to reduce bowel movement frequency in neuroendocrine tumor (NET) patients with and without carcinoid syndrome.

SECONDARY OBJECTIVES:

I. To assess subject-reported health-related quality of life measures in subjects before and after compound administration. (Functional Assessment of Chronic Illness Therapy-Diarrhea [FACIT-D], version 4, D. Cella et al.)

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

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

IV. To assess differences in intravenous fluid requirement and/or hospitalizations for dehydration in patients between observation period and active enterade period.

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

VI. To compare subjective bloating and flatulence in patients before and after administration of the compound.

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

EXPLORATORY OBJECTIVES:

I. To assess changes in serum and stool inflammatory markers (IL-1beta, IL-6 and tumor necrotic factor [TNF]alpha and serum endotoxin) before and after the study compound.

II. To evaluate changes in fecal lactoferrin before and after study compound administration.

OUTLINE:

OBSERVATION PERIOD: Patients are clinically observed for bowel movement frequency during weeks 1-4.

INTERVENTION PERIOD: Patients receive enterade orally (PO) twice daily (BID) during weeks 5-8 in the absence of disease progression or unacceptable toxicity.

POST INTERVENTION PERIOD: Patients are clinically observed for toxicity and relapse of bowel frequency symptoms during weeks 9-13.

After relapse of bowel frequency is documented, or the 4 weeks of post-intervention observation are completed (whatever happens first), patients may restart enterade for 1 additional month.

Trial Phase Phase II

Trial Type Supportive care

Lead Organization
Vanderbilt University / Ingram Cancer Center

Principal Investigator
Satya Das

  • Primary ID VICCGI1943
  • Secondary IDs NCI-2019-07295
  • Clinicaltrials.gov ID NCT04073017