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Atorvastatin for Hearing Loss in Head and Neck Cancer

Phase 2

Recruiting

Led By Lisa L Cunningham, Ph.D.

Research Sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to take oral medication by mouth or by feeding tube and willingness to adhere to the daily atorvastatin or placebo regimen

Be older than 18 years old

Must not have

Patients already taking a statin drug

Current use of cimetidine, spironolactone, ketoconazole, cyclosporine, or protease inhibitors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the overall survival and disease-free survival will be assessed at 3 months, 1 and 2 years after cisplatin-based crt. overall complete clinical response, comparing subjects taking atorvastatin (40 mg) vs those taking placebo.

Summary

This trial will study whether atorvastatin reduces hearing loss in people treated with cisplatin and radiation for head and neck squamous cell carcinoma.

Who is the study for?

This trial is for adults with squamous cell carcinoma of the head and neck who will undergo cisplatin-based chemotherapy and radiation. They must be able to take oral medication, agree to use effective contraception if applicable, and not be on statins or have certain medical conditions that could interfere with the study.

What is being tested?

The trial is testing whether atorvastatin can prevent hearing loss in patients treated with cisplatin for head and neck cancer. Participants are randomly assigned to receive either atorvastatin or a placebo daily during treatment and for three months after.

What are the potential side effects?

Atorvastatin may cause side effects like muscle pain, digestive issues, increased liver enzymes, headache, insomnia, flushing of the skin, or rash. However, specific side effects related to this trial's context aren't detailed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take pills by mouth or feeding tube and will follow the daily medication plan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking a statin medication.

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I am currently taking cimetidine, spironolactone, ketoconazole, cyclosporine, or protease inhibitors.

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I have been treated with platinum-based chemotherapy before.

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I will be taking aminoglycoside antibiotics soon.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the overall survival and disease-free survival will be assessed at 3 months, 1 and 2 years after cisplatin-based crt. overall complete clinical response, comparing subjects taking atorvastatin (40 mg) vs those taking placebo.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the overall survival and disease-free survival will be assessed at 3 months, 1 and 2 years after cisplatin-based crt. overall complete clinical response, comparing subjects taking atorvastatin (40 mg) vs those taking placebo.

This trial's timeline: 3 weeks for screening, Varies for treatment, and the overall survival and disease-free survival will be assessed at 3 months, 1 and 2 years after cisplatin-based crt. overall complete clinical response, comparing subjects taking atorvastatin (40 mg) vs those taking placebo. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Squamous cell carcinoma

Secondary study objectives

To compare the incidence of grade (Bullet)3 AEs through 4 weeks after CRT with atorvastatin versus placebo.

To determine the effectiveness of atorvastatin (40 mg) at reducing changes in hearing sensitivity relative to baseline, as defined by ASHA criteria, in subjects treated with cisplatin- based CRT for head and neck squamous cell carcinoma (HNSCC).

To examine the extent to which atorvastatin 40 mg alters overall survival and disease-free survival.