Phase 2 Study of Atorvastatin to Prevent Hearing Loss in Adults Receiving Cisplatin Chemotherapy for Head and Neck Cancer

What this Trial Is About

Researchers are evaluating whether atorvastatin, a drug commonly used to lower cholesterol, can reduce the risk of hearing loss caused by cisplatin chemotherapy in people with head and neck squamous cell carcinoma. This study focuses on individuals aged 18 and older who are undergoing treatment with cisplatin-based chemotherapy combined with radiation therapy. The study aims to compare hearing changes in patients taking atorvastatin versus a placebo to better understand its potential protective effects. Participants will be divided into two groups those already taking statin medications will join an observational arm, while those not on statins will be randomly assigned to receive either 40 mg of atorvastatin or a placebo daily. The medication or placebo will be taken by mouth or feeding tube during cisplatin treatment and for three months afterward. Study visits include hearing evaluations before treatment starts, within three months after treatment, and within two years after treatment, along with blood tests at consent and 12 weeks later. During the study, participants will undergo hearing tests using headphones and tympanograms that assess ear drum mobility. They will also complete questionnaires related to hearing at each visit. Researchers will monitor hearing loss based on specific criteria and track overall and disease-free survival up to two years after chemotherapy. Long-term follow-up includes reviewing medical records two years after treatment to assess outcomes and safety.

Atorvastatin to Reduce Cisplatin-Induced Hearing Loss Among Individuals With Head and Neck Cancer