Status:
RECRUITING
Atorvastatin to Reduce Cisplatin-Induced Hearing Loss Among Individuals With Head and Neck Cancer
Lead Sponsor:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Conditions:
Hearing Loss
Head and Neck Cancer
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
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...
Detailed Description
Study Description: Individuals undergoing cisplatin-based chemoradiation therapy (CRT) are at risk for developing significant, permanent hearing loss. The cholesterol-lowering drug atorvastatin has th...
Eligibility Criteria
Inclusion
- 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. 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 radiation). 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.
- 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
- Subjects with a history of prior treatment with platinum chemotherapy drugs
- Subjects for whom additional adjuvant platinum-based chemotherapy is planned after the completion of concomitant chemoradiation (e.g., patients with nasopharyngeal carcinoma)
- 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
Exclusion
Key Trial Info
Start Date :
July 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2030
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT04915183
Start Date
July 10 2024
End Date
August 31 2030
Last Update
May 8 2025
Active Locations (4)
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1
Winship Cancer Institute at Emory University
Atlanta, Georgia, United States, 30322
2
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
3
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
4
Wilmot Cancer Institute at the University of Rochester Medical Center in New Yor
Rochester, New York, United States, 14642