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)

GenesisCare

Status: Terminated

Conditions: Diarrhea

Treatments: Dietary Supplement: Enterade beverage

Study type: Interventional

Funder types: Other

Identifiers

NCT02381405

Enterade 11/11/14

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

A

Active Comparator group

Description:

Enterade beverage

Treatment:

Dietary Supplement: Enterade beverage

B

No Intervention group

Description:

Standard of care