Hearing Loss and the Effects of Statin Drugs in People With Head and Neck Squamous Cell Carcinoma Treated With Cisplatin Chemoradiation

NCT03225157 | Completed

• 2 other identifiers: 17013817-DC-0138
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

Background: Cisplatin is a chemotherapy drug. It is used to treat head and neck squamous cell carcinoma (HNSCC) and other cancers. It can cause hearing loss for some people. It is not known how many people will get hearing loss from cisplatin. It is also not known what other factors might influence who gets hearing loss. Factors could include age, sex, noise exposure, and other drugs the person is taking. Statins are drugs used to lower cholesterol. Statins may also reduce cisplatin-induced hearing loss. Objectives: To see if statins reduce hearing loss in people getting cisplatin therapy to treat HNSCC. To find out how many people taking cisplatin get hearing loss from it. To find out if other factors might influence whether cisplatin causes hearing loss. Eligibility: People ages 18 and older who are getting treatment with cisplatin for HNSCC Design: Participants will be screened with a review of their medical records. Participants will have 3 visits. These will be before the onset of cisplatin therapy, at about 4 weeks after they finish therapy, and about 6 months after they finish therapy. Each visit will include: Medication history Audiogram/hearing tests. Participants will wear headphones and indicate when they hear different sounds. Questions about their noise exposure history and whether they have ringing in the ears

Conditions

Head and Neck Neoplasms; Hearing Disorder; Hyperlipidemia

Keywords

Audiogram; Statins; Drug Response; Cancer Treatment; Head and Neck Cancer; Natural History

Outcome Measures

Primary Outcomes (1)

• Primary outcome measure: Determine whether head and neck cancer patients taking statin drugs for hyperlipidemia are at decreased risk of cisplatin-induced hearing loss.

  The primary outcome measure is the change in hearing sensitivity (as measured by the self-administered audiogram) between the pre-treatment (before cisplatin therapy) hearing test and the post-treatment (after completion of cisplatin therapy) audiogram. Hearing loss will be defined according to TUNE and ASHA criteria and will be compared in subjects taking statin drugs vs. subjects not taking statin drugs. Hearing status will be compared between audiograms collected at baseline (prior to treatment) to a repeated audiogram at the end of treatment (within 4 weeks of cisplatin protocol cessation).

  03/01/2022

Secondary Outcomes (1)

• Determine the incidence and severity of hearing loss in head and neck cancer patients undergoing low-dose, weekly cisplatin chemotherapy with concurrent radiation.

  03/01/2022

Study Arms (1)

1

adult patients with head and neck squamous cell carcinoma of the upper aerodigestive tract who will undergo cisplatin chemotherapy with concurrent radiation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects will be adult patients with head and neck squamous cell carcinoma of the upper aerodigestive tract who will undergo cisplatin chemotherapy with concurrent radiation.

You may qualify if:

• Adult patients over the age of 18.
• Patients with squamous cell carcinoma of the upper aerodigestive tract including the larynx, hypopharynx, oropharynx, and oral cavity who undergo treatment with concomitant cisplatin chemotherapy and intensity-modulated radiotherapy (IMRT) with curative intent.
• Patients treated with cisplatin chemoradiation either as primary/definitive or adjuvant (post-surgical) therapy.
• Subjects must be able and willing to self-administer their hearing test via the iPad following a brief tutorial with one-on-one instruction from a member of the study team or medical staff.
• Subjects must have hearing thresholds at or better than 80 dB SPL at 1, 2, and 4 kilohertz (kHz) at the time of their baseline audiogram.
• Subjects must have a Type A tympanogram.
• Subjects must be able to provide their own consent.

You may not qualify if:

• Patients with carcinoma of the nasopharynx or paranasal sinuses, who may have Eustachian tube dysfunction (with resultant conductive hearing loss) related to radiation treatment involving these anatomic subsites.
• Patients with active middle ear disease that is likely to influence the results of audiograms during the study, as determined by an Investigator who is an otolaryngologist. If a potential subject reports active middle ear disease, medical records will be reviewed by a study otolaryngologist to determine whether the patient should be excluded.
• Patients with cochlear implants will be excluded.
• Patients with a history of prior treatment with platinum chemotherapy drugs will be excluded.
• Patients who receive taxanes or other cytotoxic chemotherapy drugs in addition to cisplatin will be excluded. The standard of care is cisplatin as monotherapy for previously untreated HNSCC.
• Staff members of the NIDCD Sections that are headed by the PI and LAI will be excluded.

Sponsors & Collaborators

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

Study Sites (2)

Johns Hopkins Suburban Hospital

Bethesda, Maryland, 20814, United States

Location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Fernandez KA, Allen P, Campbell M, Page B, Townes T, Li CM, Cheng H, Garrett J, Mulquin M, Clements A, Mulford D, Ortiz C, Brewer C, Dubno JR, Newlands S, Schmitt NC, Cunningham LL. Atorvastatin is associated with reduced cisplatin-induced hearing loss. J Clin Invest. 2021 Jan 4;131(1):e142616. doi: 10.1172/JCI142616.

  PMID: 33393488 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Head and Neck Neoplasms; Hearing Disorders; Hyperlipidemias

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Lisa L Cunningham, Ph.D.

  National Institute on Deafness and Other Communication Disorders (NIDCD)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 21, 2017
• Study Start: November 3, 2017
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: May 24, 2024

Record last verified: 2024-05

Locations

US (2)