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)

Not Applicable

Terminated

• Conditions: Diarrhea
• Interventions: Dietary Supplement: Enterade beverage

• Registration Number: NCT02381405
• Lead Sponsor: GenesisCare USA

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

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-03-03
• Study First Submitted QC: 2015-03-05
• Study First Posted: 2015-03-06
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-09
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Enterade beverage	Enterade beverage

Primary Outcome Measures

Name	Time	Method
Patient reported gastrointestinal (GI) symptoms using EPIC	12 Days

Trial Locations

Locations (1)

21st Century Oncology; 🇺🇸 Jacksonville, Florida, United States