Recruiting
Phase 2

Atorvastatin with Cisplatin

Sponsor:

National Institute on Deafness and Other Communication Disorders (NIDCD)

Code:

NCT04915183

Conditions

Hearing Loss

Head and Neck Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Placebo

Atorvastatin

Study Details

Brief summary:

Background:

Cisplatin is used to treat head and neck cancer. People who take this drug are at risk for hearing loss. Atorvastatin is a drug used to treat high cholesterol. It might reduce the risk of cisplatin-induced hearing loss.

Objective:

To find out if atorvastatin reduces hearing loss in people treated with cisplatin and radiation.

Eligibility:

People ages 18 and older with squamous cell carcinoma of the head and neck who will undergo treatment with cisplatin-based chemotherapy and radiation

Design:

Participants will be screened with their medical records.

Participants currently taking a cholesterol-lowering statin medication are invited to participate in the observational arm of the study. Those not taking such a medication are invited to participate in the interventional arm of the study.

All participants will have 3 study visits for the purpose of evaluating hearing. One before starting cisplatin treatment, one within 3 months of completing cancer treatment, and one within 2 years of completing cancer treatment. They will have tympanograms. A small flexible tip will be placed in the ear canal. A puff of air will be delivered to assess mobility of the ear drum. They will have hearing tests. They will wear headphones. They will listen to tones that vary in loudness. They will be asked to indicate when they hear a sound. They will complete 3 questionnaires at the time of each hearing test.

Participants will have 2 visits for blood tests. These will occur upon consent and 12 weeks after. They will be randomly assigned to take the study drug or placebo orally, once daily. They will take it during cisplatin treatment and for 3 months after treatment.

Long-term follow up will include a chart review 2 years after participants complete their cisplatin therapy.

Conditions

Hearing Loss

Head and Neck Cancer

Study ID

NCT04915183

Start date

Jul 10, 2024

Status verified date

Aug 31, 2026

Completion date

Aug 31, 2030

Anticipated

Primary completion date

Aug 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • 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

Study Design

Enrollment

224 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1

Atorvasatatin (40 mg)

placebo comparator: 2

Placebo

Interventions

Placebo

Placebo will be formulated to also contain a white powder such that the atorvastatin and placebo are indistinguishable even if a capsule is opened.

Atorvastatin

Subjects will be provided with atorvastatin (40 mg) or placebo to be taken daily by mouth or by feeding tube. The tablets may be taken whole or crushed according to patient swallowing capabilities and preference.

Primary outcome measure

  • 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). [ Time Frame: Baseline (prior to treatment) to a repeated audiogram at the end of treatment (within 2-4 months of cessation of cisplatin administration). ]

Central Contacts and Locations

Central contacts

Katharine A Fernandez, Au.D.

(240) 215-7152katharine.fernandez@nih.gov

Lisa L Cunningham, Ph.D.

(301) 443-2766cunninghamll@mail.nih.gov

Locations

Winship Cancer Institute at Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Nicole Schmitt

404-778-0278nicole.cherie.schmitt@emory.edu

University of Maryland Medical Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Adam Kaufman

667-214-2382adam.kaufman@som.umaryland.edu

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222prpl@cc.nih.gov

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

Recruiting

Rochester, New York, United States, 14642

Contacts

Shawn Newlands

585-275-5823Shawn_Newlands@urmc.rochester.edu

Inova Schar Cancer Center

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

John Deeken, M.D.

571-472-0218john.deeken@inova.org

More Information

Sponsor

National Institute on Deafness and Other Communication Disorders (NIDCD)

Last update posted

Sep 2, 2026

Last verified

Aug 31, 2026

Keywords

  • Audiogram
  • Statin
  • Chemotherapy
  • Squamous Cell Carcinoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute on Deafness and Other Communication Disorders (NIDCD) on 2026-09-02.