Losartan in Taxane-induced Peripheral Neuropathy

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Losartan in the Prevention of Paclitaxel-induced Peripheral Neuropathy in Breast Cancer Patients.

Conditions
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Peripheral Neuropathy Due to Chemotherapy

Intervention / Treatment
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* Drug: Losartan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females older than 18 years diagnosed with biopsy-confirmed breast cancer (Early breast cancer eligible for adjuvant or neoadjuvant) who are scheduled to receive paclitaxel 80 mg/m2. Exclusion Criteria: Known hypersensitivity to Losartan. Not Known Hypertensive patients Not Known Diabetic patients Treatment with Losartan/ARBs/ACE-I prior to the study. Previous neuropathy Renal impairment (Serum creatinine > 2 mg/dl) Significant liver disease: liver enzymes 2 folds the upper normal limit Metastatic breast cancer Pregnancy or lactation Taking other medication for neuropathic pain Significant Hypotension

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control arm<br>These patients will receive standard-of-care management for chemotherapy-induced nausea and vomiting | |
| Experimental: Intervention arm<br>These patients will receive standard-of-care management for chemotherapy-induced nausea and vomiting plus losartan 100mg | Drug: Losartan<br>* Using losartan to prevent paclitaxel-induced peripheral neuropathy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of paclitaxel-induced peripheral neuropathy | Incidence of Development of paclitaxel-induced peripheral neuropathy | 12 weeks | 
| Grade of neuropathy | Neuropathy grade according to NCI Common Terminology Criteria for Adverse Events | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Patient quality of life will be assessed by Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | 12 weeks | 
| Biomarker | Level of Nerve growth factor (NGF) in Serum | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paclitaxel, Breast Cancer, Peripheral Neuropathy