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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

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Dyslipidemias

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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)

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Testicular Neoplasms

Endocrine Gland Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Endocrine System Diseases

Testicular Diseases

Gonadal Disorders

Patients with disseminated testicular cancer

the DEXA scan to measure bone and fat will be performed one time in the healthy controls and the patients participating in the cross sectional part of the study.

The patients in the longitudinal part of the study will have a DEXA scan at baseline, 1 month after the end of chemotherapy and after 1 year.

Dexa scan

the audiogram will be performed one time in the healthy controls and the patients participating in the cross sectional part of the study.

The patients in the longitudinal part of the study will have an audiogram at baseline, 1 month after the end of chemotherapy and after 1 year.

audiogram

the measurements (continuous assessment of heart rate and blood pressure using an non-invasive Finapress device) during 30 minutes will be performed one time in the healthy controls and the patients participating in the cross sectional part of the study.

The patients in the longitudinal part of the study will have those measurements taken at baseline, 1 month after the end of chemotherapy and after 1 year.

measurement of heart rate variability and baroreflex sensitivity

Glucose tolerance will be assessed by drinking glucose water and measuring glucose at baseline and 2 hours later. It will be performed one time in the healthy controls and the patients participating in the cross sectional part of the study.

The patients in the longitudinal part of the study will have an assessment at baseline, 1 month after the end of chemotherapy and after 1 year.

Glucose tolerance assessment

a set of 10 Oral Nutrition Supplements (ONS) will be offered combined with a questionnaire to measure appreciation and preference for these food products. All these tests and questionnaires will be performed longitudinally (before the first chemotherapy, on day 7 of the first course, before the second course, on day 7 of the second course, 1 month after start of the last course, 7 months after the start of chemotherapy, and 1 year after the start of chemotherapy) and cross-sectional (1, 3, 5 and 7 years after chemotherapy).

oral nutrition supplements

Two day food records will be used to investigate the actual dietary intake before the first and second course, during (on day 5 and 6) first and second course, 1 month after start of the last course, 7 months after the start of chemotherapy, and 1 year after the start of chemotherapy.

Two day food records

A Food Frequency Questionnaire (FFQ) will be used to investigate the usual dietary intake before the start of the first course, before and after the second course, 1 month after start of the last course, seven months after the start of chemotherapy, and 1 year after the start of chemotherapy (longitudinal), and 1, 3, 5 and 7 years after chemotherapy (cross-sectional).

Food Frequency Questionnaire

A KL Reyners, MD, PhD

Taste and smell abnormalities are common in cancer patients undergoing chemotherapy, with a prevalence ranging from 46% to 77% for taste changes, and 35% to 75% for smell changes. These chemosensory changes are distressing for patients and can lead to changes in appetite, food choice, and nutrient intake. These changes can result in malnutrition and weight loss. Possibly, also unhealthy eating patterns can be developed due to these taste and smell changes, given the high prevalence of obesity among survivors of certain cancer types. The primary objective is to investigate the nature, prevalence, and duration of taste and smell changes in patients with disseminated testicular cancer treated with cisplatin based chemotherapy.

Rationale: Taste and smell abnormalities are common in cancer patients undergoing chemotherapy, with a prevalence ranging from 46% to 77% for taste changes, and 35% to 75% for smell changes. These chemosensory changes are distressing for patients and can lead to changes in appetite, food choice, and nutrient intake. These changes can result in malnutrition and weight loss. Possibly, also unhealthy eating patterns can be developed due to these taste and smell changes, given the high prevalence of obesity among survivors of certain cancer types. Objective: The primary objective is to investigate the nature, prevalence, and duration of taste and smell changes in patients with disseminated testicular cancer treated with cisplatin based chemotherapy. Secondary objectives are to explore the short- and long-term consequences of these chemosensory changes for (medical) food preference, dietary intake and quality of life, and to investigate the appreciation of medical food products in these testicular cancer patients. Furthermore, it will be assessed whether changes in taste and smell are related to the metabolic syndrome, and whether chemotherapy induced neurotoxicity is related to changes in taste and smell. Study design: The present study will have a longitudinal (with measurements before the first chemotherapy, on day 7 of the first course, before the second course, on day 7 of the second course, 1 month after start of the last course, 7 months after the start of chemotherapy, and 1 year after the start of chemotherapy) and a cross-sectional (with measurements 1, 3, 5 and 7 years after chemotherapy) design. Patients can start participation in this study before the start of their chemotherapy, which will result in longitudinal data of these patients or they can start participation years after treatment, resulting in cross-sectional data.

Study population: Patients with disseminated testicular cancer treated with cisplatin based chemotherapy. This group is selected, because of the young age at diagnosis, the emetogenic chemotherapy treatment, the high survival rate, the increase in body mass index (BMI) and risk of cardiovascular disease in the long-term.

Intervention: Gustatory function will be tested using filter-paper taste strips to measure recognition thresholds for sweet, salty, sour and bitter taste. Olfactory function will be tested using Sniffin' Sticks to measure odor threshold, discrimination and recognition.

Besides, patients have to fill out questionnaires to assess taste and smell subjectively and to assess QoL. Food preference will be investigated by showing standardized photographs of sweet and savory food products, varying in fat and protein content. In addition, a set of 10 Oral Nutrition Supplements (ONS) will be offered combined with a questionnaire to measure appreciation and preference for these food products. All these tests and questionnaires will be performed longitudinally (before the first chemotherapy, on day 7 of the first course, before the second course, on day 7 of the second course, 1 month after start of the last course, 7 months after the start of chemotherapy, and 1 year after the start of chemotherapy) and cross-sectional (1, 3, 5 and 7 years after chemotherapy). Two day food records will be used to investigate the actual dietary intake before the first and second course, during (on day 5 and 6) first and second course, 1 month after start of the last course, 7 months after the start of chemotherapy, and 1 year after the start of chemotherapy. A Food Frequency Questionnaire (FFQ) will be used to investigate the usual dietary intake before the start of the first course, before and after the second course, 1 month after start of the last course, seven months after the start of chemotherapy, and 1 year after the start of chemotherapy (longitudinal), and 1, 3, 5 and 7 years after chemotherapy (cross-sectional).

A Dual Energy X-ray Absortiometrys (DEXA) scan will be used to get insight in possible changes in bone and fat mass during and after chemotherapy. To detect a possible cause of taste and smell changes, audiogram will be performed (to measure cisplatin induced neurotoxicity), and the baroreflex sensitivity (BRS) (to measure the quality of shortterm blood pressure maintenance), the blood glucose tolerance, insulin resistance, and DNA for SNP analysis will be collected. The DEXA scan, audiogram, BRS test, and blood glucose tolerance test will be performed before the first course of chemotherapy, one month after start of the last course, 1 year after the start of chemotherapy (longitudinal part), and 1, 3, 5 and 7 years after chemotherapy (cross-sectional part). A blood sample for DNA analysis will be taken at the start of the chemotherapy (longitudinal part), and 1, 3, 5 and 7 years after chemotherapy (cross-sectional part).

Taste, Smell and Chemotherapy (TASTY)

Taste and Smell Changes in Testicular Cancer Patients Treated With Cisplatin Based Chemotherapy

To investigate the nature, prevalence, and duration of taste and smell changes in patients with disseminated testicular cancer treated with cisplatin based chemotherapy (BEP (Bleomycin, Etoposide, cisPlatin) or EP (Etoposide, cisPlatin)).

Tests used are: Gustatory function will be tested using filter-paper taste strips to measure recognition thresholds for sweet, salty, sour and bitter taste. Olfactory function will be tested using Sniffin' Sticks to measure odor threshold, discrimination and recognition.

To explore the short- and long-term consequences of taste and smell changes in relation to food preference, dietary intake, and quality of life. Tests used: QoL questionnaires (EORTC QLQ-C30). Two day food records will be used to investigate the actual dietary intake before the first and second course, during (on day 5 and 6) first and second course, 1 month after start of the last course, 7 months after the start of chemotherapy, and 1 year after the start of chemotherapy. A Food Frequency Questionnaire (FFQ) will be used to investigate the usual dietary intake.

To investigate the appreciation of medical food products in patients with disseminated testicular cancer treated with cisplatin based chemotherapy.

A set of 10 Oral Nutrition Supplements (ONS) will be offered combined with a questionnaire to measure appreciation and preference for these food products.

Food preference will be investigated by showing standardized photographs of sweet and savory food products, varying in fat and protein content.

To assess whether changes in taste and smell are related to the metabolic syndrome.

Tests used: glucose tolerance test and DEXA scan.

To assess whether chemotherapy induced neurotoxicity is related to changes in taste and smell.

TEsts used: audiogram, assessment of heart rate variability and baroreflex sensitivity.

University Medical Center Groningen

Atorvastatin

Anticholesteremic Agents

Hypolipidemic Agents

Antimetabolites

Enzyme Inhibitors

Placebo will be formulated to also contain a white powder such that the atorvastatin and placebo are indistinguishable even if a capsule is opened.

Placebo

Subjects will be provided with atorvastatin (40 mg) or placebo to be taken daily by mouth or by feeding tube. The tablets may be taken whole or crushed according to patient swallowing capabilities and preference.

Katharine A Fernandez, Au.D.

Nicole Schmitt

Adam Kaufman

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

Shawn Newlands

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.

Study Description: Individuals undergoing cisplatin-based chemoradiation therapy (CRT) are at risk for developing significant, permanent hearing loss. The cholesterol-lowering drug atorvastatin has the potential to reduce the incidence and severity of hearing loss, as evidenced by our preclinical data in mice and our retrospective data in humans. Here we will compare hearing changes between subjects on a concurrent 40 mg daily dose of atorvastatin vs. a placebo among individuals undergoing cisplatin-based CRT to treat head and neck cancer.

Objectives:

Primary Objective: To determine the effectiveness of atorvastatin (40 mg) in subjects with cisplatin-based CRT for head and neck squamous cell carcinoma (HNSCC) at reducing moderate changes in hearing sensitivity relative to baseline, as defined by CTCAEv5.0 Grade\>=2 criteria.

Secondary Objectives:

* To determine disease-free survival and overall survival in subjects undergoing cisplatin-based CRT.
* To determine whether atorvastatin increases grade 3-5 treatment emergent adverse events versus placebo
* To determine the effectiveness of atorvastatin (40 mg) at reducing changes in hearing sensitivity relative to baseline, as defined by ASHA criteria, in subjects treated with cisplatin- based CRT for head and neck squamous cell carcinoma (HNSCC).

Endpoints:

Primary Endpoint: The incidence of hearing loss at 12 +/-4 weeks after completion of cisplatin-based CRT). Hearing loss will be defined according to CTCAEv5.0 Grade \>=2 criteria based on changes in sensitivity relative to baseline, in at least one ear, across 1, 2, 3, 4, 6 and 8 kHz and will be compared in subjects taking atorvastatin (40 mg) vs. subjects taking placebo.

Secondary Endpoints:

* Overall and disease-free survival at 2 years after cisplatin-based CRT. Overall survival and disease-free median survival will be compared between subjects taking atorvastatin (40 mg) vs. those taking placebo.
* Incidence of new CTCAEv5.0 grade \> 3 AEs through 12 weeks after CRT in the placebo and atorvastatin arms.
* Incidence of hearing loss at 12 +/-4 weeks after completion of cisplatin-based CRT. Hearing loss will be defined according to ASHA Abbreviated Title: Atorvastatin Study in HNSCC Version Date: 1/25/2024 7 criteria based on changes in sensitivity relative to baseline, in at least one ear, across 1, 2, 3, 4, 6, 8, 10, and 12.5 kHz and will be compared in subjects taking atorvastatin (40 mg) vs. subjects taking placebo.

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

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

The primary endpoint is the change in hearing sensitivity (as measured by pure-tone audiometry) 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 CTCAE criteria and will be compared in subjects taking atorvastatin vs. subjects not taking any statin drug. Hearing sensitivity will be compared between audiograms collected at baseline (prior to treatment) to a repeated audiogram at the end of treatment (within 2-4 months of cessation of cisplatin administration).

It is important to confirm that atorvastatin use does not reduce overall response, survival or disease- free survival in subjects with HNSCC. To date, only two retrospective studies have compared survival in HNSCC subjects taking statins.

It is important to confirm that atorvastatin does not increase the overall toxicity associated with CRT.

The American Speech-Langauge-Hearing Association (ASHA) ototoxicity criteria can be used for early detection based on changes in hearing sensitivity in extended high frequencies (\>8 kHz). While ASHA does not assign grades to indicate severity, it may provide early diagnosis of hearing loss that has not yet spread to speech-related frequency regions of the cochlea (\<8 kHz).

Study title	NCT ID	Conditions	Interventions	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)
Taste, Smell and Chemotherapy (TASTY)	NCT01641172	Testicular Canc...	Dexa scan audiogram measurement of ... Glucose toleran... oral nutrition ... Two day food re... Food Frequency ...	18 Years - 50 Years	University Medical Center Groningen
Taste, Smell and Chemotherapy (TASTY)	NCT01641172	Testicular Canc...	Dexa scan audiogram measurement of ... Glucose toleran... oral nutrition ... Two day food re... Food Frequency ...	18 Years - 50 Years	University Medical Center Groningen
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)
Atorvastatin to Reduce Cisplatin-Induced Hearing Loss Among Individuals With Head and Neck Cancer	NCT04915183	Hearing Loss Head and Neck C...	Placebo Atorvastatin	18 Years - 100 Years	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for audiogram

Every month we try and update this database with for audiogram cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for audiogram

Every month we try and update this database with for audiogram cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for audiogram cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.