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Cholesterol drug may shield ears from chemo damage

NCT ID NCT04915183

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 03, 2026 · Updated 3 times

Summary

This study tests whether atorvastatin, a widely used cholesterol medication, can reduce hearing loss caused by cisplatin chemotherapy in people with head and neck cancer. About 224 adults will be randomly assigned to take atorvastatin or a placebo daily during and for three months after their cancer treatment. Hearing tests and blood samples will be collected before, during, and up to two years after treatment to see if the drug makes a difference.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
atorvastatin
What this could lead to
If it works, this could offer a simple, low-cost way to protect hearing during chemotherapy without affecting cancer treatment.
What could go wrong
This is a mid-stage trial with 224 people, so results are not yet proven. Atorvastatin may not prevent hearing loss, and there is a small risk of side effects like muscle pain or liver issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 224 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Aug 2030

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Inova Schar Cancer Center

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

  • University of Maryland Medical Center

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • Wilmot Cancer Institute at the University of Rochester Medical Center in New Yor

    RECRUITING

    Rochester, New York, 14642, United States

  • Winship Cancer Institute at Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

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