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Paclitaxel-induced peripheral neuropathy (PIPN) is one of the most dose-limiting side effects; it causes patients discomfort and pain and sometimes causes the termination of the chemotherapy cycles, leading to treatment failure. A lot of interventions have been tried to prevent PIPN, ensure complete administration of the chemotherapy cycles, and increase the survival rate. One of the promising interventions in the prevention of PIPN is Losartan. Losartan is an angiotensin receptor blocker (ARBs) and is used to treat hypertensive patients. There is strong evidence from different preclinical studies and retrospective cohort studies that Losartan has a neuroprotective effect.
The purpose of our study is to investigate the efficacy of Losartan in the prevention of peripheral neuropathy associated with Paclitaxel treatment in Breast Cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm | No Intervention | These patients will receive standard-of-care management for chemotherapy-induced nausea and vomiting | |
| Intervention arm | Experimental | These patients will receive standard-of-care management for chemotherapy-induced nausea and vomiting plus losartan 100mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Losartan | Drug | Using losartan to prevent paclitaxel-induced peripheral neuropathy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Development of paclitaxel-induced peripheral neuropathy | Incidence and grading of paclitaxel-induced peripheral neuropathy (PIPN) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient QOL | Patient quality of life will be assessed by Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | 12 weeks |
| Pain Severity | Pain intensity will be assessed through Visaul Analogue Scale Scale 0-10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Breast Cancer Comprehensive Center of the National Cancer Institute, Cairo University | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41800821 | Derived | Mahmoud AMAS, Shash E, Ateyya H, Okasha FA, El Said NO. The Effect of Losartan in Preventing Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer: A Randomized, Controlled Study. Pharmacotherapy. 2026 Apr;46(4):e70124. doi: 10.1002/phar.70124. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D019808 | Losartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| 12 Weeks |
| Serum biomarker | Level of Nerve growth factor (NGF) in Serum | 12 weeks |
| D017437 |
| Skin and Connective Tissue Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |