Back to search results

Atorvastatin for Hearing Loss in Head and Neck Cancer

This study is looking at whether atorvastatin (a cholesterol-lowering drug) can reduce hearing loss in people with head and neck cancer who are being treated with cisplatin (a chemotherapy drug). Cisplatin can cause permanent hearing loss, and researchers believe atorvastatin might help prevent this. You could be eligible if you are 18 or older, have squamous cell carcinoma of the head and neck, and will be treated with cisplatin and radiation. The main goal is to see if atorvastatin (40 mg daily) reduces the number of people who experience moderate hearing changes compared to a placebo (an inactive substance). The study's status is currently unclear, and it plans to enroll 224 participants.

Study design
This is an interventional study where participants will receive either atorvastatin or a placebo. It aims to enroll 224 participants.
What's involved
You would take atorvastatin (40 mg) or placebo daily by mouth or feeding tube. Your hearing will be tested at the beginning of the study and again 2-4 months after your cisplatin treatment ends.
Compensation
Not stated in the trial record.
Follow-up
Your hearing will be measured at the end of treatment, within 2-4 months of stopping cisplatin administration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04915183

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
National Institute on Deafness and Other Communication Disorders (NIDCD)
~224 participants
Updated 2026-06-05 on ClinicalTrials.gov
What's tested:PlaceboAtorvastatin

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To determine the effectiveness of atorvastatin (20 mg) at reducing the incidence and severity of cisplatin-induced hearing loss in patients with head and neck squamous cell carcinoma (HNSCC).
Measured over Baseline (prior to treatment) to a repeated audiogram at the end of treatment (within 2-4 months of cessation of cisplatin administration).

Conditions

Hearing Loss
Head and Neck Cancer

Explore related trials

Head and Neck Squamous Cell CarcinomaHearing Loss

Where it's being run

5 sites across 4 states
Maryland2
Georgia1
New York1
Virginia1

Study leadership

  • Lisa L Cunningham, Ph.D. · PRINCIPAL_INVESTIGATOR · National Institute on Deafness and Other Communication Disorders (NIDCD)

Who to contact

Katharine A Fernandez, Au.D.
[email protected]
(240) 215-7152
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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
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

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

What this trial measures

  • To determine the effectiveness of atorvastatin (20 mg) at reducing the incidence and severity of cisplatin-induced hearing loss in patients with head and neck squamous cell carcinoma (HNSCC).Baseline (prior to treatment) to a repeated audiogram at the end of treatment (within 2-4 months of cessation of cisplatin administration).

    The primary endpoint is the change in hearing sensitivity (as measured by pure-tone audiometry) between the pre-treatment (before cisplatin therapy) hearing test and the post-treatment (after completion of cisplatin therapy) audiogram. Hearing loss will be defined according to CTCAE criteria and will be compared in subjects taking atorvastatin vs. subjects not taking any statin drug. Hearing sensitivity will be compared between audiograms collected at baseline (prior to treatment) to a repeated audiogram at the end of treatment (within 2-4 months of cessation of cisplatin administration).