Breast Cancer
Conditions
Keywords
breast
Brief summary
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.
Interventions
DRUGGlutamine
Oral glutamine for subjects undergoing breast conserving therapy
DRUGPlacebo
For subjects undergoing breast conserving therapy
Sponsors
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Excessive Radiation Toxicity as Defined by Radiation Therapy Oncology Group (RTOG) Acute Scale of Radiation-toxicity Criteria | 12 days and 30 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 7 |
| 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 | 7 |
| Total | 14 |
Baseline characteristics
| Characteristic | Glutamine | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 4 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 6 / 7 | 5 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 |
Outcome results
Primary
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.
Time frame: 12 days and 30 days
Population: No data displayed because Outcome Measure has zero total participants analyzed and no data was collected.