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)
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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.
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 :
Actual Primary Completion Date :
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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
CID CTCAE grade 1 or 2 (not requiring Loperamide or similar)