Glutamine for the Prevention of Radiation Toxicity in Subjects Conserving Therapy

Glutamine for the Prevention of Radiation Toxicity in Subjects Undergoing Breast Conserving Therapy

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.

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