Head and Neck NeoplasmsNCT03225157
Hearing Loss and the Effects of Statin Drugs in People With Head and Neck Squamous Cell Carcinoma Treated With Cisplatin Chemoradiation
An observational study of Head and Neck Neoplasms and Hearing Disorder, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms, Hearing Disorder, Hyperlipidemia
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Nov 2017to 28 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Suburban Hospital
Bethesda, Maryland, 20814
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Observational Study of Hearing Loss and the Effects of Statin Drugs in Head and Neck Squamous Cell Carcinoma Patients Treated With Cisplatin Chemoradiation
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.
Read more
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
Read the detailed description
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.
- Conditions
- Head and Neck Neoplasms, Hearing Disorder, Hyperlipidemia
- Keywords
- Audiogram, Statins, Drug Response, Cancer Treatment, Head and Neck Cancer, Natural History
- Medical subject headings
- Head and Neck Neoplasms, Hearing Disorders, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | adult patients with head and neck squamous cell carcinoma of the upper aerodigestive tract who will undergo cisplatin chemotherapy with concurrent radiation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
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.
Measured: 03/01/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start3 Nov 2017
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lisa L Cunningham, Ph.D., Principal investigator, National Institute on Deafness and Other Communication Disorders (NIDCD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225157
- Sponsor's protocol ID
- 170138
- Other IDs
- 17-DC-0138
- Status last verified
- May 2024
- First submitted
- 20 Jul 2017
- Last updated
- 24 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33393488
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Hearing Loss and the Effects of Statin Drugs in Head and Neck Squamous Cell Carcinoma Patients Treated With Cisplatin Chemoradiation
- ClinicalTrials.gov ID
- NCT03225157
- Acronym / sponsor ID
- 170138
- Conditions
- Head and Neck Neoplasms, Hearing Disorder, Hyperlipidemia
- Keywords
- Audiogram, Statins, Drug Response, Cancer Treatment, Head and Neck Cancer, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)US National Institutes of Health
- Study start
- 3 Nov 2017 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –adult patients with head and neck squamous cell carcinoma of the upper aerodigestive tract who will undergo cisplatin chemotherapy with concurrent radiation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary outcome measure: Determine whether head and neck cancer patients taking statin drugs for hyperlipidemia are at decreased risk of cisplatin-induced hearing loss.
Time frame: 03/01/2022
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).
1 secondary outcome
Determine the incidence and severity of hearing loss in head and neck cancer patients undergoing low-dose, weekly cisplatin chemotherapy with concurrent radiation.
Time frame: 03/01/2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Derived from this study: PubMed 33393488Fernandez 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa L Cunningham, Ph.D. principal investigator
National Institute on Deafness and Other Communication Disorders (NIDCD)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Neoplasms and Hearing Disorder, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome measure: Determine whether head and neck cancer patients taking statin drugs for hyperlipidemia are at decreased risk of cisplatin-induced hearing loss. (time frame: 03/01/2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03225157, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.