Using atorvastatin to prevent hearing loss in head and neck cancer patients receiving cisplatin

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of atorvastatin, a cholesterol-lowering medication, in reducing hearing loss among individuals with head and neck squamous cell carcinoma undergoing cisplatin-based chemotherapy and radiation. Participants aged 18 and older will be divided into two groups: one receiving atorvastatin and the other receiving a placebo. The study will evaluate changes in hearing sensitivity before and after treatment, with assessments conducted at three different time points. The primary goal is to determine if atorvastatin can significantly reduce the incidence of hearing loss compared to placebo.

Why it matters

Who can join: the full rules

* 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 radiation64-67). 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 cisplatin chemotherapy
* 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

Where it's running

• Winship Cancer Institute at Emory University
  Atlanta, Georgia, United States Recruiting
• University of Maryland Medical Center
  Baltimore, Maryland, United States Recruiting
• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting
• Wilmot Cancer Institute at the University of Rochester Medical Center in New Yor
  Rochester, New York, United States Recruiting
• Inova Schar Cancer Center
  Fairfax, Virginia, United States Recruiting

Study contacts

• Principal investigator: Lisa L Cunningham, Ph.D. — National Institute on Deafness and Other Communication Disorders (NIDCD)
• Study coordinator: Katharine A Fernandez, Au.D.
• Email: katharine.fernandez@nih.gov
• Phone: (240) 215-7152

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.