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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Enterade beverage |
|
| B | No Intervention | Standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enterade beverage | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported gastrointestinal (GI) symptoms using EPIC | 12 Days |
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Inclusion Criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 21st Century Oncology | Jacksonville | Florida | 32256 | United States |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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