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March 12, 2026

The Effect of Losartan in Preventing Paclitaxel‐Induced Peripheral Neuropathy in Breast Cancer: A Randomized, Controlled Study

Key Points

This research aims to evaluate the effectiveness of losartan in preventing paclitaxel-induced peripheral neuropathy (PIPN) in breast cancer patients.
Conducted as a single-center, open-label, randomized controlled trial.
Included women with early-stage breast cancer receiving weekly paclitaxel.
Participants were randomized to either losartan 100 mg daily plus standard care or standard care alone.
Primary endpoint assessed was the incidence of grade 2 or higher neuropathy.
Secondary endpoints included quality of life, pain intensity, serum nerve growth factor levels, and safety.
Losartan significantly reduced grade ≥ 2 neuropathy incidence (33.3% vs. 86.4%).
It delayed neuropathy onset (73.27 days vs. 43.75 days) with a hazard ratio of 0.2.
Patients on losartan reported significantly better quality of life scores (31.87 vs. 15.45) and lower pain scores (median VAS 3 vs. 8).
NGF levels and adverse events were comparable between the two groups.

Abstract

ABSTRACT Background Paclitaxel‐induced peripheral neuropathy (PIPN) is a condition that persists chronically in more than 60% of affected individuals, and currently there are no proven PIPN prophylaxis. Pre‐clinical data suggest the angiotensin‐II–receptor blocker losartan may attenuate neuro‐inflammation and nerve injury. This study was conducted to assess losartan's neuroprotective effect against PIPN in patients with breast cancer. Methods In this single‐center, open‐label, randomized, controlled trial, women with early‐stage breast cancer scheduled for weekly paclitaxel (80 mg/mg 2 or 12 doses) were enrolled and randomized 1:1 to losartan 100 mg once daily plus standard care or standard care alone. The primary end point was incidence of grade 2 or higher neuropathy, per National Cancer Institute Common Terminology Criteria of Adverse Events (NCI‐CTCAE v5.0). Secondary end points included time‐to‐neuropathy (in days), patient quality of life (QoL) assessed by Functional Assessment of Cancer Therapy/Gynecologic Oncology Group‐Neurotoxicity (FACT/GOG‐NTX), pain intensity using visual‐analogue scale (VAS), serum nerve growth factor (NGF) levels, and safety. Results Between December 2023 and December 2024, 89 Patients Were Randomized (Losartan, n = 45; Control, n = 44). Losartan Significantly Reduced Grade ≥ 2 Neuropathy Incidence (33.3% vs. 86.4%, p < 0.001) and Delayed Its Onset (73.27 vs. 43.75 Days; Hazards Ratio HR = 0.2, 95% Confidence Interval CI : 0.11–0.35) Compared With Standard Care Alone, Respectively. At 12 Weeks, Patients Treated With Losartan Reported Superior QoL ( FACT / GOG ‐ NTX : 31.87 ± 6.43 vs. 15.45 ± 10.04; p < 0.001) and Reduced Pain Scores (Median VAS 3 vs. 8; p < 0.001) Compared With Standard Care Alone, Respectively. NGF Levels Were Comparable and Adverse Events Were Similar Between Groups. Conclusions Daily losartan reduced and delayed clinically significant paclitaxel‐induced neuropathy while improving patient‐reported outcomes, without additional toxicity. These findings support repurposing losartan as a low‐cost PIPN prophylactic and justify validation in larger, multicenter trials. Trial Registration ClinicalTrials.gov ( NCT06135493 )

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The Effect of Losartan in Preventing Paclitaxel‐Induced Peripheral Neuropathy in Breast Cancer: A Randomized, Controlled Study

Key Points

Abstract

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