Glutamine for the Prevention of Radiation Toxicity in Subjects Conserving Therapy

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT02012608

Run by

University of Arkansas

People needed

14

Starts

2014-06-01

Expected to finish

2019-04-01

Last updated by the study team

2019-05-29

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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