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Patients with breast cancer receiving paclitaxel chemotherapy who have mild symptoms of peripheral neuropathy will receive glutamine or placebo to try and improve symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glutamine | Experimental | 10 grams three times a day (orally) for four days and then stop |
|
| Placebo | Placebo Comparator | 10 grams three times a day (orally) for four days and then stop |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| glutamine | Drug | 10 grams three times a day (orally) for four days and then stop |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Peripheral Neuropathy Score | Used the clinical total neuropathy score scale (TNSc). The presence of sensory, motor, pin sensibility, vibration sensibility, DTR, autonomic symptoms was assessed. For each item, the possible score ranged between 0 (normal) and 4 (worst possible result). Outcomes calculated as neuropathy score value at 10 Weeks minus neuropathy score value at Baseline. Increased score value indicates increased neuropathy severity. | Duration of study, approximately 10 weeks per subject |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda Vahdat, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Medical College of Cornell University | New York | New York | 10021 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Glutamine | 10 grams three times a day (orally) for four days and then stop glutamine: 10 grams three times a day (orally) for four days and then stop |
| FG001 | Placebo | 10 grams three times a day (orally) for four days and then stop Placebo: 10 grams three times a day (orally) for four days and then stop |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Glutamine | 10 grams three times a day (orally) for four days and then stop glutamine: 10 grams three times a day (orally) for four days and then stop |
| BG001 | Placebo | 10 grams three times a day (orally) for four days and then stop Placebo: 10 grams three times a day (orally) for four days and then stop |
| 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 | Change in Peripheral Neuropathy Score | Used the clinical total neuropathy score scale (TNSc). The presence of sensory, motor, pin sensibility, vibration sensibility, DTR, autonomic symptoms was assessed. For each item, the possible score ranged between 0 (normal) and 4 (worst possible result). Outcomes calculated as neuropathy score value at 10 Weeks minus neuropathy score value at Baseline. Increased score value indicates increased neuropathy severity. | Posted | Mean | Full Range | Change in Total Neuropathy Score | Duration of study, approximately 10 weeks per subject |
|
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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 | 10 grams three times a day (orally) for four days and then stop glutamine: 10 grams three times a day (orally) for four days and then stop |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda Vahdat, MD | Weill Cornell Medicine | 646-962-9888 | ltv2001@med.cornell.edu |
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| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D005973 | Glutamine |
| 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 | 10 grams three times a day (orally) for four days and then stop |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
10 grams three times a day (orally) for four days and then stop Placebo: 10 grams three times a day (orally) for four days and then stop |
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Placebo | 10 grams three times a day (orally) for four days and then stop Placebo: 10 grams three times a day (orally) for four days and then stop | 0 | 16 | 0 | 16 |
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| D001941 |
| Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D021542 | Amino Acids, Neutral |
| D002241 | Carbohydrates |