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Protocol Details

Observational Study of Hearing Loss and the Effects of Statin Drugs in Head and Neck Squamous Cell Carcinoma Patients Treated with Cisplatin Chemoradiation

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

17-DC-0138

Sponsoring Institute

National Institute on Deafness and Other Communication Disorders (NIDCD)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 120

Referral Letter Required

Yes

Population Exclusion(s)

None

Special Instructions

Currently Not Provided

Keywords

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

Recruitment Keyword(s)

None

Condition(s)

Head and Neck Cancer;
Hearing Disorder;
Hyperlipidemia

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Deafness and Other Communication Disorders

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

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Eligibility

INCLUSION CRITERIA:

-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.

EXCLUSION CRITERIA:

-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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

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



Nicole C. Schmitt, M.D.
National Institute on Deafness and Other Communication Disorders (NIDCD)
BG 10 RM 7N240B
10 CENTER DR
BETHESDA MD 20814
(301) 827-5619
nicole.schmitt@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT03225157

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