Neoplasms

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Head and Neck Neoplasms

Hearing Loss

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Hearing Disorders

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Ear Diseases

Otorhinolaryngologic Diseases

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All Drugs and Chemicals

Lipid Regulating Agents

Cisplatin

Hydroxymethylglutaryl-CoA Reductase Inhibitors

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

Lisa L Cunningham, Ph.D.

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

Objectives:

* Primary: Determine whether head and neck cancer patients taking statin drugs for hyperlipidemia are at decreased risk of cisplatin-induced hearing loss.
* Secondary: Determine the incidence and severity of hearing loss in head and neck cancer patients undergoing low-dose, weekly cisplatin chemotherapy with concurrent radiation. Hearing loss with this more recent cisplatin regimen has not been thoroughly evaluated in the literature. Examine whether age, gender, pre-existing hearing loss, other medications, or comorbid medical conditions may be risk factors for cisplatin-induced hearing loss and/or the acquisition or progression of tinnitus in this patient population.

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.

Design:

* Observational study
* 334 subjects will be enrolled.
* Subjects will complete a questionnaire to estimate the degree of prior noise exposure and impact on baseline hearing. Information on medical comorbidities, names and doses of current medications will be obtained from the medical record and verified at each subject visit.
* Subjects will complete self-administered audiograms using FDA-approved software from SHOEBOXTM Audiometry on a portable tablet (iPad) computer.
* Audiograms will be completed prior to commencing chemoradiation, within 4 weeks of completing treatment, and 6 months after completing treatment.
* Subjects will also complete a validated tinnitus questionnaire with each audiogram. A noise exposure history will be collected during the initial study visit and verified during subsequent visits. Any indicated changes to the subject s noise exposure history will be added to record.
* No investigational or experimental therapy will be given as part of this protocol.
* Audiograms will be performed at the Johns Hopkins Suburban Outpatient Center or the NIH Clinical Center.
* Two interim analyses will be conducted prior to study completion (after N=88 and N=176 subjects completing the protocol) to determine whether there are statistically significant differences in severity or incidence of hearing loss in subjects taking concurrent statin drugs vs. subjects who are not taking statin drugs.

Outcome Measures:

* Primary outcome measure: 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).
* Secondary outcome measure: Secondary outcome measures include 1) changes in hearing sensitivity between the first post-cisplatin audiogram and the second post-cisplatin audiogram, and 2) changes in scores on the tinnitus questionnaire between the pre-treatment audiogram and the two post-treatment audiograms.

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

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

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).

Secondary outcome measures include 1) changes in hearing sensitivity between the first post-cisplatin audiogram and the second post-cisplatin audiogram, and 2) changes in scores on the tinnitus questionnaire between the pre-treatment audiogram and the two post-treatment audiograms.

National Institute on Deafness and Other Communication Disorders (NIDCD)

Mouth and Tooth Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Pharyngeal Neoplasms

Laryngeal Diseases

Respiratory Tract Diseases

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Subjects must be diagnosed with a disorder of the head and neck region

Melissa Missy L Wheatley

Clint T Allen, M.D.

Michael Hoa, M.D.

Nyall London, M.D.

Richard Lush, Ph.D.

National Cancer Institute Referral Office

Background:

Researchers want to learn more about head and neck disorders. Understanding these disorders could help them find better treatments. To do this, they are collecting tissue samples for research.

Objective:

To create a repository of tissue samples and data to better study conditions of the head and neck.

Eligibility:

People who had or will have tissue samples taken because of a head or neck disorder. They must be ages 3 and older and not pregnant to join Part 2.

Design:

Participants will be screened with a questionnaire, medical history, and physical exam.

Part 1. Participants will give permission for any of their tissue samples leftover from private care or other research protocols to be used.

If participants tissue did not contain normal tissue or if they have a condition that suggests a genetic issue, they will be invited to join Part 2.

Part 2: Participants will have additional samples collected. These could be:

* Blood: Blood is drawn through a needle in the arm.
* Cheek swab or brushing: A cotton swab or small brush is rubbed inside the cheek.
* Saliva: They rinse their mouth with water and spit into a tube or cup.
* Skin biopsy: They are injected with a numbing drug. A biopsy tool removes a small piece of skin.
* Mucosal biopsy: They are injected in the mouth with a numbing medication. A small piece of tissue from the inside of the cheek is removed.

Participants samples will be used for future research, including genetic testing.

...

Background:

NCI Head and Neck Clinical Research Program (H\&N CRP) investigators are studying the natural history and treatment of diverse conditions of the head and neck at the National Institutes of Health (NIH). These studies require the collection of biospecimens for research purposes.

Studies performed may support development of future protocols that include new therapeutic agents, novel treatment approaches, and new prognostic and diagnostic models for individuals with disorders of the head and neck affecting human communication.

Objectives:

* Primary: To create a biorepository of diseased and normal tissue specimens for research purposes from individuals with head and neck disorders.
* Secondary: To share specimens for Patient-Derived Xenograft (PDX) and organoid research, as well as analysis of cellular, molecular, genetic and genomic biology of normal processes and disorders.

Eligibility:

* Participants must be diagnosed with a disorder of the head and neck region.
* Age \>= 3 years

Design:

* Up to 1000 participants will be enrolled.

  * Part 1: Participants with head and neck disorders will be asked to share waste material from surgical procedures to create a biorepository of diseased and normal specimens for research. The participants will be enrolled prior to the surgery, or they may be enrolled retrospectively and asked to share pathology specimens and slides previously collected that are no longer required for their medical care. Participants will be recruited from surgical protocols at the National Institutes of Health (NIH) Clinical Center or from other participating sites.
  * Part 2: Participants who have agreed to share surgical waste material may be asked to provide additional blood, saliva, and/or oral swabs. In addition, oral mucosal or skin biopsies may be obtained from adult participants aged 18 and older.
* No investigational or experimental therapy will be given as part of this protocol.

Biospecimen Procurement for Head and Neck Disorders

Biospecimen Procurement for the Study of Head and Neck Disorders

The primary endpoint of this study is the creation of a head and neck biorepository from both surgical waste material and prospectively collected blood, saliva, oral swabs, oral mucosa biopsy and skin biopsy specimens.

National Cancer Institute (NCI)

Background:

Researchers want to learn more about head and neck disorders. Understanding these disorders could help them find better treatments. To do this, they are collecting tissue samples for research.

Objective:

To create a repository of tissue samples and data to better study conditions of the head and neck.

Eligibility:

People who had or will have tissue samples taken because of a head or neck disorder. They must be ages 3 and older and not pregnant to join Part 2.

Design:

Participants will be screened with a questionnaire, medical history, and physical exam.

Part 1. Participants will give permission for any of their tissue samples leftover from private care or other research protocols to be used.

If participants tissue did not contain normal tissue or if they have a condition that suggests a genetic issue, they will be invited to join Part 2.

Part 2: Participants will have additional samples collected. These could be:

* Blood: Blood is drawn through a needle in the arm.
* Cheek swab or brushing: A cotton swab or small brush is rubbed inside the cheek.
* Saliva: They rinse their mouth with water and spit into a tube or cup.
* Skin biopsy: They are injected with a numbing drug. A biopsy tool removes a small piece of skin.
* Mucosal biopsy: They are injected in the mouth with a numbing medication. A small piece of tissue from the inside of the cheek is removed.

Participants samples will be used for future research, including genetic testing.

Study title	NCT ID	Conditions	Eligibility	Organization
Hearing Loss and the Effects of Statin Drugs in People With Head and Neck Squamous Cell Carcinoma Treated With Cisplatin Chemoradiation	NCT03225157	Head and Neck N... Hearing Disorde... Hyperlipidemia	18 Years -	National Institutes of Health Clinical Center (CC)
Biospecimen Procurement for Head and Neck Disorders	NCT03429036	Hearing Disorde... Oral Mucosal Di... Pharyngeal Neop... Head and Neck N... Laryngeal Disea...	3 Years - 120 Years	National Institutes of Health Clinical Center (CC)
Hearing Loss and the Effects of Statin Drugs in People With Head and Neck Squamous Cell Carcinoma Treated With Cisplatin Chemoradiation	NCT03225157	Head and Neck N... Hearing Disorde... Hyperlipidemia	18 Years -	National Institutes of Health Clinical Center (CC)
Biospecimen Procurement for Head and Neck Disorders	NCT03429036	Hearing Disorde... Oral Mucosal Di... Pharyngeal Neop... Head and Neck N... Laryngeal Disea...	3 Years - 120 Years	National Institutes of Health Clinical Center (CC)

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