Glutamine for the Prevention of Radiation Toxicity in Subjects Conserving Therapy

Phase 2

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: Glutamine; Drug: Placebo

• Registration Number: NCT02012608
• Lead Sponsor: University of Arkansas

Brief Summary

This study is a single-centered, double-blind, two-arm randomized study to determine if oral glutamine will reduce radiation toxicity for the subjects undergoing Breast Conserving Therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-03
• Study First Submitted QC: 2013-12-10
• Study First Posted: 2013-12-16
• Study Start: 2014-06
• Primary Completion: 2019-04
• Study Completion: 2019-04
• Results First Submitted: 2019-04-29
• Status Verified: 2019-05
• Results First Submitted QC: 2019-05-28
• Last Update Submitted: 2019-05-28
• Results First Posted: 2019-05-29
• Last Update Posted: 2019-05-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 14

Inclusion Criteria

• Subject have been diagnosed with Stage I or II invasive breast cancer
• Subject will undergo Accelerated Partial Breast Irradiation (APBI) as part of Breast Conserving Therapy (BCT)
• Subject is eligible for APBI based on American Society of Therapeutic Radiation Oncology (ASTRO) criteria
• Subject is 18 years of age or older
• Subject is female

Exclusion Criteria

• History of uncontrolled, clinically significant lung, heart, endocrine, liver, or renal disease
• Subject has been diagnosed with any other cancer
• Subject has a known hypersensitivity reaction to the following: oral glutamine (GLN), glutamate, monosodium glutamate (MSG) (i.e., Chinese restaurant syndrome)
• Subject has history of collagen vascular disease
• Subject has been diagnosed with Diabetes mellitus I or II
• Subject has had any prior breast radiation
• Subject is pregnant or breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glutamine	Glutamine	Powdered Glutamine, 10.0 grams by mouth three times a day (TID) for 30 days, so that daily dose is 30 grams per day
Placebo	Placebo	Powdered Dextrose, 8.33 grams by mouth TID for 30 days, so that daily dose is 25 grams per day

Primary Outcome Measures

Name	Time	Method
Excessive Radiation Toxicity as Defined by Radiation Therapy Oncology Group (RTOG) Acute Scale of Radiation-toxicity Criteria	12 days and 30 days	The primary efficacy outcome will be excessive toxicity, which will be defined as a score of 2 or higher using the Radiation Therapy Oncology Group (RTOG) Acute scale of radiation-toxicity criteria when scored on either the 12-day or 30-day assessment time.; The RTOG scale ranges from 0-4 with 0 being defined as "no change".

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States