Glutamine for the Prevention of Radiation Toxicity in Subjects Conserving Therapy

• Status: Terminated
• Trial end date: 2019-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arkansas

Criteria

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