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Lack of funding/ PI leaving institution
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glutamine | Active Comparator | 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 | Placebo Comparator | Powdered Dextrose, 8.33 grams by mouth TID for 30 days, so that daily dose is 25 grams per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glutamine | Drug | Oral glutamine for subjects undergoing breast conserving therapy |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Loverd Peacock, MD | University of Arkansas | Principal Investigator |
| Yihong Kaufmann, PhD | University of Arkansas | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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". | No data displayed because Outcome Measure has zero total participants analyzed and no data was collected. | Posted | 12 days and 30 days |
|
3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| skin hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
Outcome measures not computed because data would not be statistically relevant.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Beth Scanlan | University of Arkansas for Medical Sciences | 501-686-8274 | bscanlan@uams.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 8, 2017 | Apr 25, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D005973 | Glutamine |
| D005947 | Glucose |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
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| Placebo | Drug | For subjects undergoing breast conserving therapy |
|
|
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
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 |
| 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 |
|
| 0 |
| 7 |
| 0 |
| 7 |
| 6 |
| 7 |
| EG001 | 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 | 0 | 7 | 0 | 7 | 5 | 7 |
| skin erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| breast pain | Reproductive system and breast disorders | Systematic Assessment |
|
| fatigue | General disorders | Systematic Assessment |
|
| asymptomatic breast edema | Reproductive system and breast disorders | Systematic Assessment |
|
| breast fibrosis/fat necrosis | Reproductive system and breast disorders | Systematic Assessment |
|
| telangiectasia | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| hyperkalemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| decreased lymphocyte count | Blood and lymphatic system disorders | Systematic Assessment |
|
| increased alkaline phosphatase | Blood and lymphatic system disorders | Systematic Assessment |
|
| chloride out of range | Blood and lymphatic system disorders | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D021542 | Amino Acids, Neutral |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D002241 | Carbohydrates |