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)
| Status: | Terminated |
|---|---|
| Conditions: | Irritable Bowel Syndrome (IBS) |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2015 |
| End Date: | December 2015 |
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)
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.
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.
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)
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