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)

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Diarrhea

Intervention / Treatment
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* Dietary Supplement: Enterade beverage


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Enterade beverage | Dietary Supplement: Enterade beverage<br> <br> |
| No Intervention: B<br>Standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported gastrointestinal (GI) symptoms using EPIC |  | 12 Days |