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)

Diarrhea Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02381405
• Other study ID #: Enterade 11/11/14
• Status: Terminated
• Phase: N/A
• Start date: February 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2020
• Source: 21st Century Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Two patients will be enrolled on the treatment arm for each patient on the control arm.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diarrhea

Intervention

Dietary Supplement:
• Enterade beverage

Locations

Country	Name	City	State
United States	21st Century Oncology	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
21st Century Oncology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient reported gastrointestinal (GI) symptoms using EPIC		12 Days