Glutamine for the Prevention of Radiation Toxicity in Subjects Conserving Therapy
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
- Breast Cancer
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
| Arm | Description | Assigned 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 |
|
|
Placebo Comparator Placebo |
Powdered Dextrose, 8.33 grams by mouth TID for 30 days, so that daily dose is 25 grams per day |
|
Recruiting Locations
More Details
- NCT ID
- NCT02012608
- Status
- Terminated
- Sponsor
- University of Arkansas