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History of Changes for Study: NCT02381405
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)
Latest version (submitted January 9, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 5, 2015 None (earliest Version on record)
2 January 11, 2016 Recruitment Status, Study Status, Contacts/Locations and Study Design
3 July 13, 2016 Study Status and Sponsor/Collaborators
4 January 9, 2020 Study Status
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Study NCT02381405
Submitted Date:  March 5, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: Enterade 11/11/14
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)
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2015
Overall Status: Recruiting
Study Start: February 2015
Primary Completion: February 2016 [Anticipated]
Study Completion:
First Submitted: March 3, 2015
First Submitted that
Met QC Criteria:
March 5, 2015
First Posted: March 6, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
March 5, 2015
Last Update Posted: March 6, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: GenesisCare USA
Responsible Party: Sponsor
Collaborators: Enterade USA, LLC
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Diarrhea
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 46 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: A
Enterade beverage
Dietary Supplement: Enterade beverage
No Intervention: B
Standard of care
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Patient reported gastrointestinal (GI) symptoms using EPIC
[ Time Frame: 12 Days ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Patients with any combination of therapies including radiation therapy alone, chemotherapy alone, TKI alone, or any combination are eligible.
  2. This includes patients with therapies including Xeloda (capecitabine), Camptosar (irinotecan) or 5-FU (fluorouracil) with cancer.
  3. Patients who have been diagnosed with a CID CTCAE toxicity of grade 3 or higher
  4. Patients must be at least 18 years of age.
  5. ECOG performance status 0-2.
  6. 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:

  1. ECOG performance status 3 or greater.
  2. Pregnant and/or breast-feeding women
  3. 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
  4. Post-menopausal status is defined either by:
    1. age ≥55 years and one year or more of amenorrhea,
    2. age <55 years and one year or more of amenorrhea with an estradiol assay <20 pg/mL
    3. bilateral oophorectomy
    4. CID CTCAE grade 1 or 2 (not requiring Loperamide or similar)
Open or close this module Contacts/Locations
Central Contact Person: Lisa Lunsford, RN
Telephone: (904) 493-7684
Email: lisa.lunsford@21co.com
Locations: United States, Florida
21st Century Oncology
[Recruiting]
Jacksonville, Florida, United States, 32256
Contact:Contact: Lisa Lunsford, RN 904-493-7684 lisa.lunsford@21co.com
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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