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Atorvastatin for Hearing Loss in Head and Neck Cancer

Phase 3
Waitlist Available
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
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 patients 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 64-67). Patients 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.
Ability to provide consent and provision of signed and dated informed consent form
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (prior to treatment) to a repeated audiogram at the end of treatment (within 2-4 months of cessation of cisplatin administration).
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 have squamous cell carcinoma of the head and neck and will be treated with specific chemotherapy and radiation.
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I can make my own medical decisions and have signed the consent form.
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I can take pills by mouth or feeding tube and will follow the daily medication plan.
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I am willing and able to follow all study requirements and be available for its duration.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (prior to treatment) to a repeated audiogram at the end of treatment (within 2-4 months of cessation of cisplatin administration).
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (prior to treatment) to a repeated audiogram at the end of treatment (within 2-4 months of cessation of cisplatin administration). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Squamous cell carcinoma
Secondary outcome measures
To examine the extent to which other statin drugs (and other doses of atorvastatin) reduce the incidence and severity of cisplatin-induced hearing loss in patients with head and neck squamous cell carcinoma

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 1Experimental Treatment2 Interventions
randomization to either placebo or atorvastin
Group II: 2Active Control1 Intervention
observational
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atorvastatin
1998
Completed Phase 4
~10900

Find a Location

Who is running the clinical trial?

National Institute on Deafness and Other Communication Disorders (NIDCD)Lead Sponsor
325 Previous Clinical Trials
177,974 Total Patients Enrolled
Lisa L Cunningham, Ph.D.Principal InvestigatorNational Institute on Deafness and Other Communication Disorders (NIDCD)
1 Previous Clinical Trials
32 Total Patients Enrolled

Media Library

1 Clinical Trial Eligibility Overview. Trial Name: NCT04915183 — Phase 3
Head and Neck Cancers Research Study Groups: 1, 2
Head and Neck Cancers Clinical Trial 2023: 1 Highlights & Side Effects. Trial Name: NCT04915183 — Phase 3
1 2023 Treatment Timeline for Medical Study. Trial Name: NCT04915183 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the FDA sanction this medication?

"This proposed treatment has previously been proven both effective and safe in a Phase 3 trial, thus it receives a 3 on our safety scale."

Answered by AI

Are researchers looking for more participants in this trial?

"This trial is no longer recruiting patients. The listing was created on November 9th, 2022 and was last updated on November 3rd, 2022. However, there are 666 other trials for patients with hearing loss and 73 other trials for this treatment that are actively recruiting patients."

Answered by AI

What are some common reasons why patients receive this type of care?

"This treatment can help manage lipidemias, postoperative thromboembolism, and anginal pain."

Answered by AI

What is the estimated patient pool for this clinical trial?

"As of right now, this clinical trial is not looking for any more participants. This study was initially posted on November 9th, 2022 and was edited for the last time on November 3rd, 2022. If you need assistance finding other studies, there are 666 trials recruiting patients with hearing loss and 73 trials recruiting patients for this specific treatment."

Answered by AI

Does this clinical trial break new ground?

"Since 2005, this medication has been under continuous scrutiny by the medical community. The first study, sponsored by Merck Sharp & Dohme LLC, took place in 2005 with 80 patients. After the Phase 4 drug approval in 2005, there are now 73 live studies with this treatment in 162 cities and 28 countries."

Answered by AI
~124 spots leftby Mar 2025