Clinical trial · Interventional
Glutamine for the Prevention of Radiation Toxicity in Subjects Conserving Therapy
Glutamine for the Prevention of Radiation Toxicity in Subjects Undergoing Breast Conserving Therapy
NCT02012608CI-TRIAL-00038817terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of funding/ PI leaving institution
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Glutamine | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Glutamine
- description
- Powdered Glutamine, 10.0 grams by mouth three times a day (TID) for 30 days, so that daily dose is 30 grams per day
- interventionNames
- Drug: Glutamine
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Powdered Dextrose, 8.33 grams by mouth TID for 30 days, so that daily dose is 25 grams per day
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Excessive Radiation Toxicity as Defined by Radiation Therapy Oncology Group (RTOG) Acute Scale of Radiation-toxicity Criteria
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.