DiarrheaNCT02381405
A Study Evaluating a Proprietary Amino Acid Mixture (Enterade®)- for Maintaining Bowel Regularity in Patients With GI Toxicity From Any Combination of Therapy Including Tyrosine Kinase Inhibitors (TKI)
A study testing Enterade beverage in people with Diarrhea, run by GenesisCare USA at 1 site in United States.
Trial summary
This is an open label, randomized investigation of a proprietary blend of amino acids, called Enterade®, and its effect on irregularity (diarrhea) caused by radiation therapy and/or chemotherapy including TKI*. Subjects will be randomized to receive Enterade® or continue standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diarrhea
- What is being tested?
- Enterade beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Dec 2015
- 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
- Patients with any combination of therapies including radiation therapy alone, chemotherapy alone, TKI alone, or any combination are eligible.
- This includes patients with therapies including Xeloda (capecitabine), Camptosar (irinotecan) or 5-FU (fluorouracil) with cancer.
- Patients who have been diagnosed with a CID CTCAE toxicity of grade 3 or higher
- Patients must be at least 18 years of age.
- ECOG performance status 0-2.
- Patients must have diarrhea symptoms, judged secondary to the systemic therapy, combined systemic therapy, and/or radiation, and must be requiring loperamide or similar (Imodium®) for symptom management. For the purposes of this study, diarrhea will be defined as three or more loose or liquid stools per day or loose watery stool (greater volume of stool) that occur more frequently than usual and lasting for more than three days.
Who cannot join
- ECOG performance status 3 or greater.
- Pregnant and/or breast-feeding women
- Pre-menopausal subjects as well as subjects with ovarian radiation or concomitant treatment with an LH-RH agonist/antagonist must have a negative pregnancy test and agree to use an adequate method of contraception as recommended by their treating physicians
- Post-menopausal status is defined either by:
- age ≥55 years and one year or more of amenorrhea,
- age <55 years and one year or more of amenorrhea with an estradiol assay <20 pg/mL
- bilateral oophorectomy
- CID CTCAE grade 1 or 2 (not requiring Loperamide or similar)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Open Label Study Evaluating a Proprietary Amino Acid Mixture (Enterade®)- for Maintaining Bowel Regularity in Patients With GI Toxicity From Any Combination of Therapy Including Tyrosine Kinase Inhibitors (TKI)
This is an open label, randomized investigation of a proprietary blend of amino acids, called Enterade®, and its effect on irregularity (diarrhea) caused by radiation therapy and/or chemotherapy including TKI*. Subjects will be randomized to receive Enterade® or continue standard of care. Two patients will be enrolled on the treatment arm for each patient on the control arm.
- Conditions
- Diarrhea
- Being tested
- Enterade beverage
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enterade beverageDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Enterade beverage Receives: Dietary Supplement: Enterade beverage |
| B | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported gastrointestinal (GI) symptoms using EPIC
Measured: 12 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- GenesisCare USA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381405
- Sponsor's protocol ID
- Enterade 11/11/14
- Status last verified
- Jan 2020
- First submitted
- 3 Mar 2015
- Last updated
- 13 Jan 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open Label Study Evaluating a Proprietary Amino Acid Mixture (Enterade®)- for Maintaining Bowel Regularity in Patients With GI Toxicity From Any Combination of Therapy Including Tyrosine Kinase Inhibitors (TKI)
- ClinicalTrials.gov ID
- NCT02381405
- Acronym / sponsor ID
- Enterade 11/11/14
- Conditions
- Diarrhea
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 7 participants (actual)
- Lead sponsor
- GenesisCare USAUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 6 Mar 2015 (estimated)
- 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, randomized investigation of a proprietary blend of amino acids, called Enterade®, and its effect on irregularity (diarrhea) caused by radiation therapy and/or chemotherapy including TKI*. Subjects will be randomized to receive Enterade® or continue standard of care. Two patients will be enrolled on the treatment arm for each patient on the control arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Dietary Supplement: Enterade beverageEnterade beverage |
| B | No intervention | –Standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with any combination of therapies including radiation therapy alone, chemotherapy alone, TKI alone, or any combination are eligible.
- This includes patients with therapies including Xeloda (capecitabine), Camptosar (irinotecan) or 5-FU (fluorouracil) with cancer.
- Patients who have been diagnosed with a CID CTCAE toxicity of grade 3 or higher
- Patients must be at least 18 years of age.
- ECOG performance status 0-2.
Key exclusion criteria (8 listed)
- ECOG performance status 3 or greater.
- Pregnant and/or breast-feeding women
- Pre-menopausal subjects as well as subjects with ovarian radiation or concomitant treatment with an LH-RH agonist/antagonist must have a negative pregnancy test and agree to use an adequate method of contraception as recommended by their treating physicians
- Post-menopausal status is defined either by:
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 beverage | Dietary supplement | A |
Primary outcome
Patient reported gastrointestinal (GI) symptoms using EPIC
Time frame: 12 Days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 beverage in people with Diarrhea, run by GenesisCare USA 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 6 inclusion and 8 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 13 Jan 2020. 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. 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?
Patient reported gastrointestinal (GI) symptoms using EPIC (time frame: 12 Days). 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 13 Jan 2020.