Neuroendocrine TumorNCT04073017
Enterade in Carcinoid/Non-Carcinoid Syndrome Neuroendocrine Tumor Patients With Quality of Life Limiting Bowel Frequency
A study testing Enterade® and Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (version 4.0) in people with Neuroendocrine Tumor and Carcinoid Syndrome, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumor, Carcinoid Syndrome
- What is being tested?
- Enterade® and Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (version 4.0)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2019to 18 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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/or Telotristat Ethyl). Additionally, a plasma 5-HIAA, or a urine 24-hour 5-HIAA or plasma secretory hormone levels (VIP, gastrin) above the upper limit of normal per reference lab. Patients may be grouped into this cohort based on a previous plasma 5-HIAA level though the final cohort determination will be made based upon the 5-HIAA level drawn during screening.
- 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 results for one of the following: plasma 5-HIAA, or 24-hour urine 5-HIAA or other plasma secretory hormone levels (VIP, gastrin) above the upper limit of normal per reference lab. Patients may be grouped into this cohort based on a previous plasma 5-HIAA level though the final cohort determination will be made based upon the 5-HIAA level drawn during screening
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
About this study
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
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.
Read the 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.
- Conditions
- Neuroendocrine Tumor, Carcinoid Syndrome
- Being tested
- Enterade®, Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (version 4.0)
- Medical subject headings
- Neuroendocrine Tumors, Serotonin Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enterade®Dietary supplement
Participants will drink an 8 ounce bottle of Enterade® twice a day for 4 weeks
Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (version 4.0)Other
Also called FACIT-D
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Enterade | Experimental | Carcinoid Syndrome: Participants will drink a bottle of Enterade two time per day for 4 weeks. Receives: Dietary Supplement: Enterade®; Other: Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (version 4.0) |
| Experimental | Experimental | Non-Carcinoid Syndrome: Participants will drink a bottle of Enterade two time per day for 4 weeks. Receives: Dietary Supplement: Enterade®; Other: Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (version 4.0) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bowel movement frequency
Changes in number of average daily bowel movements from baseline
Measured: At 8 weeks
Secondary outcomes (13)
Health-Related Quality of Life: Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (FACIT-D) version 4.0
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.
Measured: At 8 weeks
Tolerability of enterade®: number of enterade® drinks consumed
Measured by the total number of enterade® drinks consumed
Measured: At 8 weeks
Incidents adverse events
NCI CTCAE version 5.0
Measured: At 8 weeks
Change in serum electrolytes (Sodium)
The electrolyte sodium will be assessed for each patient before and after enterade® (measured in mmol/L)
Measured: At 8 weeks
Change in serum electrolytes (Potassium)
The electrolyte potassium will be assessed for each patient before and after enterade® (measured in mmol/L)
Measured: At 8 weeks
Change in serum electrolytes (Chloride)
The electrolyte chloride will be assessed for each patient before and after enterade® (measured in mmol/L)
Measured: At 8 weeks
Change in serum electrolytes (Magnesium)
The electrolyte magnesium will be assessed for each patient before and after enterade® (measured in mg/dL )
Measured: At 8 weeks
Change in serum electrolytes (Phosphorous)
The electrolyte phosphorous will be assessed for each patient before and after enterade® (measured in mg/dL )
Measured: At 8 weeks
Differences in intravenous fluid requirements
Measured by the number of incidence requiring intravenous fluid before and after taking enterade®
Measured: At 8 weeks
Differences in use of standard-of-care anti-diarrhea medications
Measured by reported incidence of standard-of-care anti-diarrhea medications usage before and after taking enterade®
Measured: At 8 weeks
Differences in bloating
Measured by reported incidence of bloating before and after taking enterade®
Measured: At 8 weeks
Differences in flatulence
Measured by reported incidence of flatulence before and after taking enterade®
Measured: At 8 weeks
Changes in weight
Measured by fluctuation in weight before and after taking enterade®
Measured: At 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start4 Nov 2019
- Primary completion18 May 2021
- Study completion18 May 2021
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Entrinsic Bioscience Inc.
- Responsible party
- Principal investigator, Satya Das, Vanderbilt-Ingram Cancer Center
- Investigators
- Satya Das, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073017
- Sponsor's protocol ID
- VICC GI 1943
- Status last verified
- May 2021
- First submitted
- 26 Aug 2019
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04073017
- Acronym / sponsor ID
- VICC GI 1943
- Conditions
- Neuroendocrine Tumor, Carcinoid Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- Entrinsic Bioscience Inc.
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 18 May 2021 (actual)
- Study completion
- 18 May 2021 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enterade | Experimental | Dietary Supplement: Enterade®, Other: Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (version 4.0)Carcinoid Syndrome: Participants will drink a bottle of Enterade two time per day for 4 weeks. |
| Experimental | Experimental | Dietary Supplement: Enterade®, Other: Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (version 4.0)Non-Carcinoid Syndrome: Participants will drink a bottle of Enterade two time per day for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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/or Telotristat Ethyl). Additionally, a plasma 5-HIAA, or a urine 24-hour 5-HIAA or plasma secretory hormone levels (VIP, gastrin) above the upper limit of normal per reference lab. Patients may be grouped into this cohort based on a previous plasma 5-HIAA level though the final cohort determination will be made based upon the 5-HIAA level drawn during screening.
- 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 results for one of the following: plasma 5-HIAA, or 24-hour urine 5-HIAA or other plasma secretory hormone levels (VIP, gastrin) above the upper limit of normal per reference lab. Patients may be grouped into this cohort based on a previous plasma 5-HIAA level though the final cohort determination will be made based upon the 5-HIAA level drawn during screening
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enterade®Participants will drink an 8 ounce bottle of Enterade® twice a day for 4 weeks | Dietary supplement | Enterade, Experimental |
| Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (version 4.0)Also: FACIT-DAncillary studies | Other | Enterade, Experimental |
Primary outcome
Change in bowel movement frequency
Time frame: At 8 weeks
Changes in number of average daily bowel movements from baseline
13 secondary outcomes
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
Tolerability of enterade®: number of enterade® drinks consumed
Time frame: At 8 weeks
Incidents adverse events
Time frame: At 8 weeks
Change in serum electrolytes (Sodium)
Time frame: At 8 weeks
Change in serum electrolytes (Potassium)
Time frame: At 8 weeks
Change in serum electrolytes (Chloride)
Time frame: At 8 weeks
Change in serum electrolytes (Magnesium)
Time frame: At 8 weeks
Change in serum electrolytes (Phosphorous)
Time frame: At 8 weeks
Differences in intravenous fluid requirements
Time frame: At 8 weeks
Differences in use of standard-of-care anti-diarrhea medications
Time frame: At 8 weeks
Differences in bloating
Time frame: At 8 weeks
Differences in flatulence
Time frame: At 8 weeks
Changes in weight
Time frame: At 8 weeks
Results and safety
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Satya Das, MD principal investigator
Vanderbilt-Ingram Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enterade® and Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (version 4.0) in people with Neuroendocrine Tumor and Carcinoid Syndrome, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bowel movement frequency (time frame: At 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2021.