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New treatment option for Hearing Loss
Official title Atorvastatin to Reduce Cisplatin-Induced Hearing Loss Among Individuals With Head and Neck Cancer
ClinicalTrials.gov ID: NCT04915183
What this study is testing
What is Atorvastatin?
Atorvastatin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hearing loss.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Background: Cisplatin is used to treat head and neck cancer. People who take this drug are at risk for hearing loss.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- 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...
- 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 people, 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...
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this study:
- people currently taking a statin drug
- people with bilateral flat, Type B tympanogram
- people 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.
- people with a history of prior treatment with cisplatin chemotherapy
See the full eligibility 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 people, 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...
- people 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...
- 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...
- An individual who meets any of the following criteria will be excluded from participation in this study:
- people currently taking a statin drug
- people with bilateral flat, Type B tympanogram
- people 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.
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Baltimore, Maryland, United States
- Bethesda, Maryland, United States
- Rochester, New York, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; Baltimore, Maryland, United States; Bethesda, Maryland, United States; Rochester, New York, United States; Fairfax, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.