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)

NCT02381405 | Terminated

• 1 other identifier: Enterade 11/11/14
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diarrhea

Outcome Measures

Primary Outcomes (1)

• Patient reported gastrointestinal (GI) symptoms using EPIC

  12 Days

Study Arms (2)

A

ACTIVE COMPARATOR

Enterade beverage

Dietary Supplement: Enterade beverage

B

NO INTERVENTION

Standard of care

Interventions

Enterade beverage DIETARY_SUPPLEMENT

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• GenesisCare USA: lead

Study Sites (1)

21st Century Oncology

Jacksonville, Florida, 32256, United States

Location

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2015
• First Posted: March 6, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

US (1)