Glutamine for the Prevention of Radiation Toxicity in Subjects Conserving Therapy
NCT ID: NCT02012608
Last Updated: 2019-05-29
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
14 participants
INTERVENTIONAL
2014-06-30
2019-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
Glutamine
Oral glutamine for subjects undergoing breast conserving therapy
Placebo
Powdered Dextrose, 8.33 grams by mouth TID for 30 days, so that daily dose is 25 grams per day
Placebo
For subjects undergoing breast conserving therapy
Interventions
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Glutamine
Oral glutamine for subjects undergoing breast conserving therapy
Placebo
For subjects undergoing breast conserving therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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University of Arkansas
OTHER
Responsible Party
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Principal Investigators
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Loverd Peacock, MD
Role: PRINCIPAL_INVESTIGATOR
University of Arkansas
Yihong Kaufmann, PhD
Role: STUDY_CHAIR
University of Arkansas
Locations
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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202253
Identifier Type: -
Identifier Source: org_study_id
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