# Atorvastatin to Reduce Cisplatin-Induced Hearing Loss in Head and Neck Cancer Patients

> **NIH NIH U01** · EMORY UNIVERSITY · 2024 · $543,623

## Abstract

PROJECT SUMMARY
Cisplatin is a widely-used and effective drug that is used to treat a variety of cancers. Cisplatin has several
significant side effects, including permanent hearing loss (ototoxicity), which reduces quality of life for cancer
survivors and can be dose limiting. There is a major unmet clinical need for therapies that reduce cisplatin-induced hearing loss without compromising the therapeutic efficacy of cisplatin. Our published work in animal
models suggests that statins, a class of FDA-approved drugs that are commonly used to manage
hypercholesterolemia, reduce cisplatin-induced hearing loss. Retrospective data in humans undergoing
cisplatin therapy to treat head and neck squamous cell carcinoma (HNSCC) indicate that subjects taking
atorvastatin had significantly reduced cisplatin-induced hearing loss compared to those not taking any statin
drug. This study is a multi-site, randomized, placebo-controlled interventional trial designed to determine the
extent to which atorvastatin reduces cisplatin-induced hearing loss in patients with head and neck cancer. As
primary objective, we will determine the extent to which atorvastatin reduces the incidence and severity of
cisplatin-induced hearing loss in patients with HNSCC. Subjects with previously untreated HNSCC who are
scheduled for cisplatin-based chemoradiation therapy (CRT) and are not already taking a statin will be
randomized to receive either oral atorvastatin (40 mg) or placebo daily throughout CRT. Baseline audiometric
thresholds will be measured prior to onset of cisplatin therapy and again 3 months after completion of all cycles
of cisplatin. The primary outcome is the difference in incidence of a CTCAEv5.0 Grade 2 hearing loss following
cisplatin-based CRT comparing subjects taking atorvastatin vs. those taking a placebo. As a secondary
objective, we will assess for differences between atorvastatin and placebo groups in patient-reported outcomes
focusing on overall quality of life, hearing, balance, tinnitus, and peripheral neuropathy. As an exploratory
objective, we will estimate whether statins affect survival in patients with HNSCC. Subjects will be followed for
two years after CRT to estimate 2-year overall and disease-free survival.

## Key facts

- **NIH application ID:** 10911965
- **Project number:** 5U01DC020452-02
- **Recipient organization:** EMORY UNIVERSITY
- **Principal Investigator:** NABIL F SABA
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $543,623
- **Award type:** 5
- **Project period:** 2023-09-01 → 2029-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10911965

## Citation

> US National Institutes of Health, RePORTER application 10911965, Atorvastatin to Reduce Cisplatin-Induced Hearing Loss in Head and Neck Cancer Patients (5U01DC020452-02). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10911965. Licensed CC0.

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