Breast Cancer Clinical Trial

Glutamine for the Prevention of Radiation Toxicity in Subjects Conserving Therapy

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

14

Study ID:

NCT02012608

Recruitment Status:

Terminated

Sponsor:

University of Arkansas

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There is 1 Location for this study

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University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

14

Study ID:

NCT02012608

Recruitment Status:

Terminated

Sponsor:


University of Arkansas

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