Glutamine for the Prevention of Radiation Toxicity in Subjects Conserving Therapy

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Glutamine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glutamine<br>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<br>* Oral glutamine for subjects undergoing breast conserving therapy<br>* Other names: Q;|
| Placebo Comparator: Placebo<br>Powdered Dextrose, 8.33 grams by mouth TID for 30 days, so that daily dose is 25 grams per day | Drug: Placebo<br>* For subjects undergoing breast conserving therapy<br>* Other names: Sugar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Excessive Radiation Toxicity as Defined by Radiation Therapy Oncology Group (RTOG) Acute Scale of Radiation-toxicity Criteria | The primary efficacy outcome will be excessive toxicity, which will be defined as a score of 2 or higher using the Radiation Therapy Oncology Group (RTOG) Acute scale of radiation-toxicity criteria when scored on either the 12-day or 30-day assessment time. The RTOG scale ranges from 0-4 with 0 being defined as no change. | 12 days and 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast