Your session is about to expire
← Back to Search
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
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.
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 belowSelect...
I can take pills by mouth or feeding tube and will follow the daily medication plan.
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.
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 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.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 1Experimental Treatment2 Interventions
Atorvasatatin (40 mg)
Group II: 2Placebo Group1 Intervention
Placebo
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
330 Previous Clinical Trials
178,257 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have squamous cell carcinoma of the head and neck and will be treated with specific chemotherapy and radiation.Your blood test results for AST, ALT, CPK, and creatinine are too low.I am currently taking a statin medication.I can make my own medical decisions and have signed the consent form.I can take pills by mouth or feeding tube and will follow the daily medication plan.I am currently taking cimetidine, spironolactone, ketoconazole, cyclosporine, or protease inhibitors.I am scheduled for more chemotherapy after my current treatment for cancer in the nose and throat area.I am willing and able to follow all study requirements and be available for its duration.I have been treated with platinum-based chemotherapy before.You need to have fairly good hearing in at least one ear, with a specific level of hearing ability at different pitches.You have cochlear implants in both ears.I will be taking aminoglycoside antibiotics soon.I am over 18 years old.I am 18 years old or older.You have a specific type of ear test result called a flat, Type B tympanogram.
Research Study Groups:
This trial has the following groups:- Group 1: 1
- Group 2: 2
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger