Clinical Research Directory

* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria evaluated by the study team, including an on-site oncologist: * Willingness and ability to comply with and participate in all study procedures and availability for the duration of the study * Ability to provide consent and provision of signed and dated informed consent form * Adult subjects, aged \>=18 * Diagnosed with squamous cell carcinoma of the head and neck, confirmed by a pathologic review of surgical or biopsy specimen(s), who meet standard clinical and laboratory criteria and will undergo treatment with concomitant cisplatin-based chemotherapy and radiation with curative intent or treatment with neoadjuvant chemotherapy (NAC). This includes subjects who will be treated with either intensity-modulated radiation therapy (IMRT) or proton radiotherapy, with planned dose to the cochlea \<35 Gy (to limit confounding effects of radiation). Patients receiving immunotherapy in addition to cisplatin chemoradiation are eligible. Subjects treated with either high-dose cisplatin (typically 100 mg/m\^2 x 2-3 doses every three weeks) or low-dose, weekly cisplatin (typically 40 mg/m\^2 x 6-7 doses weekly) may enroll. Cisplatin in the neo-adjuvant setting may be given within a combination chemotherapy regimen (e.g TPF= Docetaxel, Cisplatin and 5FU or DC = Docetaxel Cisplatin) * Subjects must have hearing thresholds at or better than 70 dB HL at 1, 2, and 4 kHz in at least one ear at the time of their baseline audiogram. CTCAE criteria (primary endpoint) and ASHA criteria (secondary endpoint) are based on changes in hearing in at least one ear with one ototoxicity event/grade assigned per person. * Baseline laboratory tests with lab values \<1.5x the upper limit of normal: aspartate aminotransferase (AST or SGOT); alanine aminotransferase; creatine phosphokinase, creatinine * Ability to take oral medication by mouth or by feeding tube and willingness to adhere to the daily atorvastatin or placebo regimen * For females of reproductive potential: use of highly effective contraception for at least 1 month prior to enrollment and agreement to use such a method during study participation and for an additional 8 weeks after the end of atorvastatin administration EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: * Subjects currently taking a statin drug * Subjects with bilateral flat, Type B tympanogram * Subjects with bilateral cochlear implants * Pre-existing liver or kidney disease that in the opinion of the investigator would interfere with taking Atorvastatin 40 mg daily. * Subjects with a history of prior treatment with platinum chemotherapy drugs * Staff members of the NIDCD Sections and of the lead site investigators headed by the PIs * Children will be excluded because HNSCC in children under age 18 is exceedingly rare * Current use of cimetidine, spironolactone, ketoconazole, cyclosporine, protease inhibitors, gemfibrozil, clarithromycin or itraconazole * Pregnancy, lactation, or plan to become pregnant * Known allergic reactions to components of atorvastatin or the placebo * Other severe or unstable medical conditions which clinical site PI believes increase risk to safety or ability to complete study * Expected concomitant use of aminoglycoside antibiotics