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Enterade in Carcinoid/Non-Carcinoid Syndrome Neuroendocrine Tumor Patients With Quality of Life Limiting Bowel Frequency

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ClinicalTrials.gov Identifier: NCT04073017
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : November 6, 2019
Sponsor:
Collaborator:
Entrinsic Health Solutions, Inc.
Information provided by (Responsible Party):
Satya Das, Vanderbilt-Ingram Cancer Center

Brief Summary:
This is an open-label phase II basket study evaluating the ability of enterade® to reduce bowel frequency in neuroendocrine tumor (NET) patients with carcinoid syndrome and non-carcinoid syndrome.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumor Carcinoid Syndrome Dietary Supplement: Enterade® Other: Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (version 4.0) Not Applicable

Detailed Description:

Primary Objective:

- To assess the ability of enterade to reduce bowel movement frequency in NET patients with and without carcinoid syndrome.

Secondary Objectives:

  • To assess subject-reported health-related quality of life measures in subjects before and after compound administration.
  • 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.
  • To evaluate changes in serum electrolytes before and after administration of the compound.
  • To assess differences in intravenous fluid requirement and/or hospitalizations for dehydration in patients between observation period and active enterade® period.
  • To evaluate differences in utilization of standard-of-care anti-diarrheal medications in patients between observation period and enterade® period.
  • To compare subjective bloating and flatulence in patients before and after administration of the compound.
  • To evaluate changes in patient weight before and after administration of the compound.

Exploratory Objectives:

  • To assess changes in serum and stool inflammatory markers before and after the study compound.
  • To evaluate changes in fecal lactoferrin before and after study compound administration.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Proprietary Amino Acid-Based Medical Food (Enterade) in Carcinoid Syndrome and Non-Carcinoid Syndrome Neuroendocrine Tumor Patients With Quality of Life Limiting Bowel Frequency
Actual Study Start Date : November 4, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2022


Arm Intervention/treatment
Experimental: Enterade
Carcinoid Syndrome: Participants will drink a bottle of Enterade two time per day for 4 weeks.
Dietary Supplement: Enterade®
Participants will drink an 8 ounce bottle of Enterade® twice a day for 4 weeks

Other: Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (version 4.0)
Ancillary studies
Other Name: FACIT-D

Experimental: Experimental
Non-Carcinoid Syndrome: Participants will drink a bottle of Enterade two time per day for 4 weeks.
Dietary Supplement: Enterade®
Participants will drink an 8 ounce bottle of Enterade® twice a day for 4 weeks

Other: Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (version 4.0)
Ancillary studies
Other Name: FACIT-D




Primary Outcome Measures :
  1. Change in bowel movement frequency [ Time Frame: At 8 weeks ]
    Changes in number of average daily bowel movements from baseline


Secondary Outcome Measures :
  1. Health-Related Quality of Life: Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (FACIT-D) version 4.0 [ Time Frame: At 8 weeks ]
    The FACIT-D is a questionnaire composed of 5 categories (physical well-being, social/family well-being, emotional well-being, functional well-being and additional concerns). Each category has 6-11 questions which are scored on a 0 (not at all) to 4 (very much) scale. Groups of categories are scored differently. For example in the additional concerns, emotional well-being and physical well-being categories, a higher score reflects poorer quality of life. In the family well-being and functional well-being categories, a higher score indicates better outcomes.

  2. Tolerability of enterade®: number of enterade® drinks consumed [ Time Frame: At 8 weeks ]
    Measured by the total number of enterade® drinks consumed

  3. Incidents adverse events [ Time Frame: At 8 weeks ]
    NCI CTCAE version 5.0

  4. Change in serum electrolytes (Sodium) [ Time Frame: At 8 weeks ]
    The electrolyte sodium will be assessed for each patient before and after enterade® (measured in mmol/L)

  5. Change in serum electrolytes (Potassium) [ Time Frame: At 8 weeks ]
    The electrolyte potassium will be assessed for each patient before and after enterade® (measured in mmol/L)

  6. Change in serum electrolytes (Chloride) [ Time Frame: At 8 weeks ]
    The electrolyte chloride will be assessed for each patient before and after enterade® (measured in mmol/L)

  7. Change in serum electrolytes (Magnesium) [ Time Frame: At 8 weeks ]
    The electrolyte magnesium will be assessed for each patient before and after enterade® (measured in mg/dL )

  8. Change in serum electrolytes (Phosphorous) [ Time Frame: At 8 weeks ]
    The electrolyte phosphorous will be assessed for each patient before and after enterade® (measured in mg/dL )

  9. Differences in intravenous fluid requirements [ Time Frame: At 8 weeks ]
    Measured by the number of incidence requiring intravenous fluid before and after taking enterade®

  10. Differences in use of standard-of-care anti-diarrhea medications [ Time Frame: At 8 weeks ]
    Measured by reported incidence of standard-of-care anti-diarrhea medications usage before and after taking enterade®

  11. Differences in bloating [ Time Frame: At 8 weeks ]
    Measured by reported incidence of bloating before and after taking enterade®

  12. Differences in flatulence [ Time Frame: At 8 weeks ]
    Measured by reported incidence of flatulence before and after taking enterade®

  13. Changes in weight [ Time Frame: At 8 weeks ]
    Measured by fluctuation in weight before and after taking enterade®



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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 lab.

Non-Carcinoid syndrome

  • Participants who have histopathologically confirmed neuroendocrine tumor and have 4 or more bowel movements per day on standard antidiarrheal 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.

    • 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 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 3 months.
  • Pregnant or breastfeeding women. The safety of enterade® has not been validated in this patient population.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04073017


Contacts
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Contact: Vanderbilt-Ingram Service Information Program 800-811-8480 cip@vanderbilt.edu

Locations
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United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Vanderbilt-Ingram Service Information Program    800-811-8480    cip@vumc.org   
Principal Investigator: Satya Das, MD         
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Entrinsic Health Solutions, Inc.
Investigators
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Principal Investigator: Satya Das, MD Vanderbilt-Ingram Cancer Center

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Responsible Party: Satya Das, Sponsor Investigator, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT04073017     History of Changes
Other Study ID Numbers: VICC GI 1943
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Carcinoid Tumor
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Neoplasms, Glandular and Epithelial
Malignant Carcinoid Syndrome
Syndrome
Serotonin Syndrome
Disease
Pathologic Processes
Adenocarcinoma
Carcinoma
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders