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There are several mechanisms concerning pathophysiology of paclitaxel induced peripheral neuropathy. One of the main mechanisms is induction of Schwann cell dedifferentiation by paclitaxel. At the preclinical level, cilostazol potently inhibited paclitaxel-induced dedifferentiation of cultured Schwann cells, yet this positive effect have not been clinically investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | Cilostazol 100 mg twice daily for treatment period |
|
| Control | Placebo Comparator | placebo twice daily for treatment period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cilostazol | Drug | Cilostazol 100 mg twice daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria | Number of patients reported neuropathy from paclitaxel | 8 weeks post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of chemotherapy induced-peripheral neuropathy | Severity of paclitaxel induced peripheral neuropathy using VAS visual analogue scale. | 8 weeks |
| the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity(FACT-GOG-NTX) subscale |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effects | any adverse/ side effect will be evaluated | 8 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University | Al Mansurah | 35516 | Egypt |
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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 |
|---|---|
| D000077407 | Cilostazol |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
Placebo twice daily |
|
Measures quality of life related to signs and symptoms of paclitaxel induced peripheral neuropathy |
| 8 weeks |
| Serum nerve growth factor | measuring serum level of nerve growth factor using ELISA KIT | 8 weeks |
| Serum malionaldehyde | measuring serum level of maliomaldehyde using spectrophometric kit | 8 weeks |
| D001941 |
| Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |