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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Glutamine 		Powdered Glutamine, 10.0 grams by mouth three times a day (TID) for 30 days, so that daily dose is 30 grams per day
  • Drug: Glutamine
    Oral glutamine for subjects undergoing breast conserving therapy
    Other names:
    • Gln
    • Q
Placebo Comparator
Placebo 		Powdered Dextrose, 8.33 grams by mouth TID for 30 days, so that daily dose is 25 grams per day
  • Drug: Placebo
    For subjects undergoing breast conserving therapy
    Other names:
    • Dextrose
    • Dextrose monohydrate
    • Sugar

Recruiting Locations

More Details

NCT ID
NCT02012608
Status
Terminated
Sponsor
University of Arkansas

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.