Cholesterol drug may shield ears from chemo damage
NCT ID NCT04915183
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 224 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Aug 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Inova Schar Cancer Center
RECRUITINGFairfax, Virginia, 22031, United States
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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University of Maryland Medical Center
RECRUITINGBaltimore, Maryland, 21201, United States
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Wilmot Cancer Institute at the University of Rochester Medical Center in New Yor
RECRUITINGRochester, New York, 14642, United States
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Winship Cancer Institute at Emory University
RECRUITINGAtlanta, Georgia, 30322, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a smartphone app replace the clinic for hearing aid tuning?
- Why do Non-Smokers get head and neck cancer? scientists probe tumor DNA
- Re-irradiation plus cetuximab targets head and neck tumors that return
- Sharper tumor maps: PET scans could tighten radiation beams
- 30 years of cochlear implant data could reshape hearing care in china