Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02381405
Recruitment Status : Terminated
First Posted : March 6, 2015
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
GenesisCare USA

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Diarrhea Dietary Supplement: Enterade beverage Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: A
Enterade beverage
 Dietary Supplement: Enterade beverage
No Intervention: B
Standard of care


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Patient reported gastrointestinal (GI) symptoms using EPIC [ Time Frame: 12 Days ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02381405


Locations
Layout table for location information
United States, Florida
21st Century Oncology
Jacksonville, Florida, United States, 32256
Sponsors and Collaborators
GenesisCare USA
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: GenesisCare USA
ClinicalTrials.gov Identifier: NCT02381405    
Other Study ID Numbers: Enterade 11/11/14
First Posted: March 6, 2015    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
Layout table for MeSH terms
Diarrhea
Signs and Symptoms, Digestive