Glutamine for the Prevention of Radiation Toxicity in Subjects Conserving Therapy

University of Arkansas

Status and phase

Terminated

Phase 2

Conditions

Breast Cancer

Treatments

Drug: Placebo

Drug: Glutamine

Study type

Interventional

Funder types

Other

Identifiers

NCT02012608

202253

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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