General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT04915183

Background Information

Individuals undergoing cisplatin-based chemoradiation therapy (CRT) are at risk for developing significant, permanent hearing loss. The cholesterol-lowering drug atorvastatin has the potential to reduce the incidence and severity of hearing loss, as evidenced by our preclinical data in mice and our retrospective data in humans. This study will compare hearing changes between subjects on a concurrent 40 mg daily dose of atorvastatin vs. a placebo among individuals undergoing cisplatin-based CRT to treat head and neck cancer. 

Primary Objective is to determine the effectiveness of atorvastatin (40 mg) in subjects treated with cisplatin- based CRT for head and neck squamous cell carcinoma (HNSCC) at reducing moderate changes in hearing sensitivity relative to baseline, as defined by CTCAEv5.0 Grade≥2 criteria. 

For more information, please visit: https://clinicaltrials.gov/study/NCT04915183

Offered At

Inova Schar Cancer Institute
A division of Inova Fairfax Hospital
8081 Innovation Park Drive 
Fairfax, VA 22031
 
Principal Investigator

John Deeken, MD

Eligibility Information

  • 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. 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). Subjects treated with either high-dose cisplatin (typically 100 mg/m2 x 2-3 doses every three weeks) or low-dose, weekly cisplatin (typically 40 mg/m2 x 6-7 doses weekly) may enroll.
  • 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 
 

Ineligibility Information

  • Subjects currently taking a statin drug 

  • Subjects with bilateral flat, Type B tympanogram 

  • Subjects with bilateral cochlear implants  

  • Pre-existing liver or kidney disease  

  • Subjects with a history of prior treatment with platinum chemotherapy drugs

  • Subjects for whom additional adjuvant platinum-based chemotherapy is planned after the completion of concomitant chemoradiation (e.g., patients with nasopharyngeal carcinoma)