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

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

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 2 visits. One before starting cisplatin treatment and within 3 months of completing 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.

Participants in the interventional arm will have 2 additional 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Treatments: Atorvastatin

Criteria

• INCLUSION CRITERIA:

In order to be eligible to participate in either the observational or interventional arms of this study, an individual must meet all of the following criteria as 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

• Adult patients, male or female, aged >=18

• Diagnosed with squamous cell carcinoma of the head and neck, confirmed by pathologic review of surgical or biopsy specimen(s), who meets standard clinical and laboratory criteria and will undergo treatment with concomitant cisplatin-based chemotherapy and radiation with curative intent.

• This includes patients who will be treated with either intensity-modulated radiation therapy (IMRT) or proton radiotherapy, with planned dose to the cochlea of <35 Gy (to limit confounding effects of radiation).

• Subjects must have hearing thresholds at or better than 70 dB SPL at 1, 2, and 4 kilohertz (kHz) at the time of their baseline audiogram.

• Ability to provide consent and provision of signed and dated informed consent form

In order to be eligible to participate in the interventional arm of this study, an individual must meet all of the

following criteria:

• Baseline laboratory tests in the following range: aspartate aminotransferase (AST or SGOT); alanine aminotransferase; creatine phosphokinase, creatinine <1.5x ULN.

• Ability to take oral medication by mouth or by feeding tube 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.

The investigators will attempt to enroll subjects of diverse race, gender and age. However, our ability to do this will be limited by the demographics of patients typically diagnosed with HNSCC. There is a male predominance, and patients tend to be in their 5th to 7th decades of life ("Cancer of the Oral Cavity and Pharynx - Cancer Stat Facts," n.d.).

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in the observational or interventional arms of this study:

• Patients with a Type B tympanogram.

• Patients with bilateral cochlear implants will be excluded.

• Patients with a history of prior treatment with platinum chemotherapy drugs will be excluded.

• Patients for whom additional adjuvant platinum-based chemotherapy is planned after the completion of concomitant chemoradiation (e.g., patients with nasopharyngeal carcinoma) will be excluded.

• Staff members of the NIDCD Sections and of the lead site investigators that are headed by the PI and LAI will be excluded.

• Children will be excluded because HNSCC in children under age 18 is exceedingly rare.

An individual who meets any of the following criteria will be excluded from participation in the interventional arm of this study:

• Current use of cimetidine, spironolactone, ketoconazole, cyclosporine, or protease inhibitors for HIV or hepatitis C

• Pregnancy, lactation, or plan to become pregnant

• Known allergic reactions to components of atorvastatin or the placebo

• Other severe or unstable medical conditions for which clinical site PI believes increase risk to safety or being able to complete study.