RECRUITING

Atorvastatin to Reduce Cisplatin-Induced Hearing Loss Among Individuals With Head and Neck Cancer

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Conditions

Hearing LossHead and Neck CancerAudiogramStatinChemotherapySquamous Cell Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase II Interventional Study Using Atorvastatin to Reduce Cisplatin-Induced Hearing Loss Among Individuals With Head and Neck Cancer

Quick Facts

Study Start:2024-07-10
Study Completion:2030-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04915183

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Willingness and ability to comply with and participate in all study procedures and availability for the duration of the study
  2. * Ability to provide consent and provision of signed and dated informed consent form
  3. * Adult subjects, male or female, aged \>=18
  4. * 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.
  5. * Subjects 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
  6. * Baseline laboratory tests with lab values \<1.5x the upper limit of normal: aspartate aminotransferase (AST or SGOT); alanine aminotransferase; creatine phosphokinase, creatinine
  7. * Ability to take oral medication by mouth or by feeding tube and willingness to adhere to the daily atorvastatin or placebo regimen
  8. * 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 end of atorvastatin administration
  1. * Subjects currently taking a statin drug
  2. * Subjects with bilaterial flat, Type B tympanogram
  3. * Subjects with bilateral cochlear implants
  4. * Pre-existing liver or kidney disease.
  5. * Subjects with a history of prior treatment with platinum chemotherapy drugs
  6. * Subjects for whom additional adjuvant platinum-based chemotherapy is planned after the completion of concomitant chemoradiation (e.g., patients with nasopharyngeal carcinoma)
  7. * Staff members of the NIDCD Sections and of the lead site investigators headed by the PIs
  8. * Children will be excluded because HNSCC in children under age 18 is exceedingly rare
  9. * Current use of cimetidine, spironolactone, ketoconazole, cyclosporine, or protease inhibitors, gemfibrozil, clarithromysin or itraconazole
  10. * Pregnancy, lactation, or plan to become pregnant
  11. * Known allergic reactions to components of atorvastatin or the placebo
  12. * Other severe or unstable medical conditions which clinical site PI believes increase risk to safety or ability to complete study
  13. * Expected concomitant use of aminoglycoside antibiotics

Contacts and Locations

Study Contact

Katharine A Fernandez, Au.D.
CONTACT
(240) 215-7152
katharine.fernandez@nih.gov
Lisa L Cunningham, Ph.D.
CONTACT
(301) 443-2766
cunninghamll@mail.nih.gov

Principal Investigator

Lisa L Cunningham, Ph.D.
PRINCIPAL_INVESTIGATOR
National Institute on Deafness and Other Communication Disorders (NIDCD)

Study Locations (Sites)

Winship Cancer Institute at Emory University
Atlanta, Georgia, 30322
United States
University of Maryland Medical Center
Baltimore, Maryland, 21201
United States
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States
Wilmot Cancer Institute at the University of Rochester Medical Center in New Yor
Rochester, New York, 14642
United States

Collaborators and Investigators

Sponsor: National Institute on Deafness and Other Communication Disorders (NIDCD)

  • Lisa L Cunningham, Ph.D., PRINCIPAL_INVESTIGATOR, National Institute on Deafness and Other Communication Disorders (NIDCD)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-10
Study Completion Date2030-08-31

Study Record Updates

Study Start Date2024-07-10
Study Completion Date2030-08-31

Terms related to this study

Keywords Provided by Researchers

  • Audiogram
  • Statin
  • Chemotherapy
  • Squamous Cell Carcinoma

Additional Relevant MeSH Terms

  • Hearing Loss
  • Head and Neck Cancer