Planned Observational Study of Hearing Loss and the Effects of Statin Drugs in Head and Neck Squamous Cell Carcinoma Patients Treated With Chemoradiation

Abstract

The incidence of hearing loss in head and neck squamous cell carcinoma (HNSCC) patients treated with cisplatin chemoradiation has not been well-established, particularly for low-dose, weekly (40 mg/m2) regimens. Preclinical and retrospective clinical data suggest that statin drugs may partially mitigate cisplatin-induced hearing loss. Barriers to study of hearing loss in cancer patients include limited access to audiology services during the short window of time between cancer diagnosis and initiation of treatment. We hypothesize that a substantial proportion of HNSCC patients treated with low-dose, weekly cisplatin, and concurrent radiation therapy will develop clinically relevant hearing loss, which will be of lower magnitude in patients taking statin drugs for hyperlipidemia. We sought to design an observational study that would facilitate the comparison of pretreatment and posttreatment audiograms on HNSCC patients treated with chemoradiation. Eligible patients will include patients with confirmed HNSCC of the oral cavity, oropharynx, larynx, or hypopharynx for whom definitive or adjuvant chemoradiation with weekly cisplatin is planned. A tympanogram and audiogram will be obtained prior to treatment and at 1 month and 6 months posttreatment. An FDA-approved software will be used with calibrated headphones for self-administered audiograms on a tablet (iPad) device. Medications, including statin drugs, will be tracked throughout treatment. This prospective observational study has been IRB approved, and preliminary results will be presented. Despite lower overall toxicity, low-dose, weekly cisplatin chemoradiation regimens for HNSCC continue to cause clinically significant hearing loss. Information on the incidence and severity of the resulting hearing loss would be helpful for the counseling of patients. Statin drugs have shown promise in preliminary studies as a possible preventive intervention, but prospective clinical data are needed.