Back to resultsA 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)
Primary Purpose
Diarrhea
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enterade beverage
Sponsored by
About this trial
This is an interventional treatment trial for Diarrhea
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
Sites / Locations
- 21st Century Oncology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
A
B
Arm Description
Enterade beverage
Standard of care
Outcomes
Primary Outcome Measures
Patient reported gastrointestinal (GI) symptoms using EPIC
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02381405
Brief Title
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)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Study Start Date
February 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GenesisCare USA
4. Oversight
5. Study Description
Brief 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. Two patients will be enrolled on the treatment arm for each patient on the control arm.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Enterade beverage
Arm Title
B
Arm Type
No Intervention
Arm Description
Standard of care
Intervention Type
Dietary Supplement
Intervention Name(s)
Enterade beverage
Primary Outcome Measure Information:
Title
Patient reported gastrointestinal (GI) symptoms using EPIC
Time Frame
12 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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)
Facility Information:
Facility Name
21st Century Oncology
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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)
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