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| Name | Class |
|---|---|
| TSPC America, Inc. | INDUSTRY |
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The purpose of the study is to determine whether daily, high-dose administration of l-glutamine can reduce numbness and tingling caused by a taxane chemotherapy in patients with breast cancer.
L-glutamine has previously been shown to help reduce the incidence of numbness and tingling in patients with breast cancer who are receiving taxane chemotherapies. However, no study to date looks at the effect of l-glutamine given after this numbness and tingling (called 'perihperhal neuropathy') has already occurred. We hypothesize that administration of this amino acid in l-glutamine naïve patients will result in a measureable reduction of their taxane-induced neuropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L-Glutamine | Experimental | All patients will receive 20-30 grams of l-glutamine daily for 9 weeks (+/- 1 week) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-glutamine | Dietary Supplement | 10,000mg by mouth, twice daily for nine weeks (± 7 days) with one permitted dose escalation to a maximum of 10,000mg by mouth three times daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total sensory neuropathy (area under the curve [AUC]) as measured by the EORTC QLQ-CIPN20 at baseline and week 9 | nine weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assess Quality of Life |
|
| Measure | Description | Time Frame |
|---|---|---|
| Observe progression-free survival for 36 months post-intervention with l-glutamine supplementation | Quarterly record review to determine progression-free survival for 36 months post-l-glutamine intervention | 40 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jack Medendorp | Eastern Regional Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastern Regional Medical Center | Philadelphia | Pennsylvania | 19124 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15997923 | Background | Stubblefield MD, Vahdat LT, Balmaceda CM, Troxel AB, Hesdorffer CS, Gooch CL. Glutamine as a neuroprotective agent in high-dose paclitaxel-induced peripheral neuropathy: a clinical and electrophysiologic study. Clin Oncol (R Coll Radiol). 2005 Jun;17(4):271-6. doi: 10.1016/j.clon.2004.11.014. | |
| 11350883 | Background |
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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 |
| ID | Term |
|---|---|
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
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|
| nine weeks |
| Vahdat L, Papadopoulos K, Lange D, Leuin S, Kaufman E, Donovan D, Frederick D, Bagiella E, Tiersten A, Nichols G, Garrett T, Savage D, Antman K, Hesdorffer CS, Balmaceda C. Reduction of paclitaxel-induced peripheral neuropathy with glutamine. Clin Cancer Res. 2001 May;7(5):1192-7. |
| D001941 |
| Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D021542 | Amino Acids, Neutral |