Atorvastatin Study in HNSCC/UHAN21082/Newlands
Research Question:
NA
Basic Study Information
Purpose:
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.
Location: Wilmot Cancer Institute at the University of Rochester Medical Center in New Yor
Lead Researcher (Principal Investigator)
Lead Researcher:
Shawn Newlands
Study Contact Information
Study Contact: Clinical Trials Office
Study Location: Wilmot Cancer Institute, University of Rochester Medical Center
Study Email: WCICTOResearch@urmc.rochester.edu
Additional Study Details
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