Symptoms and General Pathology

All Conditions

Neoplasms

Ear, Nose, and Throat Diseases

Nervous System Diseases

Rare Diseases

Ischemia

Facies

Neurilemmoma

Neuroma, Acoustic

Neuroma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Nervous System Neoplasms

Peripheral Nervous System Neoplasms

Vestibulocochlear Nerve Diseases

Retrocochlear Diseases

Ear Diseases

Otorhinolaryngologic Diseases

Otorhinolaryngologic Neoplasms

Cranial Nerve Diseases

Schwannoma

Acoustic Neuroma

Neuroendocrine Tumor

Neuroepithelioma

On the right upper extremity a blood pressure cuff is inflated to 200mmHg for 4x5min at the beginning of the surgery

On the right upper extremity a blood pressure cuff is inflated to 0mmHg for 4x5min at the beginning of the surgery

A blood pressure cuff is inflated to 200 mmHg for 4x5 min (5 min rest between cycles) at the right upper extremity when the vestibular schwannoma surgery is started

Remote ischemic preconditioning

A blood pressure cuff is inflated to 0 mmHg for 4x5 min (5 min rest between cycles) at the right upper extremity when the vestibular schwannoma surgery is started

Sham-control

Helene V Hurth, MD

Constantin Roder, Prof., MD

Contantin Roder, Prof., MD

Vestibular schwannomas are primarily benign (WHO grade I) tumors originating from the Schwann cells of the vestibular nerve and are among the most common tumors of the skull base. Common treatment options are surgical tumor resection or targeted radiation therapy. The special challenge of surgical treatment is the functional preservation of the cranial nerves, especially the cochlear and facial nerves. Perioperative ischemia of the cochlea and cochlear nerve is postulated as the underlying mechanism of postoperative hearing loss. Ischemic preconditioning is a non-invasive procedure that triggers the release of vasoactive cytokines and mediators by repeated short-term induction of limb ischemia. Improved perfusion of critically perfused end organs as well as a reduction of cerebral infarct volumes has already been shown in other pathologies. In the planned study, possible neuroprotective effects of remote ischemic preconditioning on postoperative hearing as well as facial nerve function in patients with vestibular schwannomas will be examined.

Purpose: Does remote ischemic preconditioning improve hearing and/or facial nerve palsy after resection of vestibular schwannomas?

Study Design: Prospective, randomized, double-blind, single-center.

Case number: The study should include 120 patients (60 treatment arm, 60 control arm). Case number calculation (mean effect sizes, chi-square test, alpha error = 0.05, beta error = 20%) results in a necessary total patient number of 100 with 50 patients per group. Including the expected dropout rate (approx. 20%), the required total number of study participants is set at 120 patients. With approximately 55 patients/year in whom anatomic preservation of the cochlear nerve is possible intraoperatively, the total study duration is estimated to be approximately 2-2.5 years.

Study procedure: Day 1

* Preoperative pure tone audiometry including speech discrimination and preoperative AEP measurement
* preoperative assessment of facial nerve function according to House and Brackmann and photo documentation
* Preoperative blood sample (Hg, WBC, platelet count, creatinine, sodium, potassium, CRP, PCT, IL-6, INR, Quick, aPTT, d-dimer)
* Evaluation of inclusion and exclusion criteria, informed consent

Day 2

* Randomization
* At skin incision RIC procedure or sham control.

  * RIC arm: 5 minutes inflation of a blood pressure cuff to 200mmHg on the right arm, then 5 minutes rest, the procedure will be performed 4 times in total.
  * Control arm: 5 minutes inflation of a blood pressure cuff to 0mmHg on the right arm, then 5 minutes rest, the procedure will be performed 4 times in total.
* Performance of tumor resection under electrophysiological monitoring.
* blood sample (Hg, WBC, platelet count, creatinine, sodium, potassium, CRP, PCT, IL-6, INR, Quick, aPTT, d-dimer)

Day 3

* blood sample (Hg, WBC, platelet count, creatinine, sodium, potassium, CRP, PCT, IL-6, INR, Quick, aPTT, d-dimer)
* Clinical assessment of facial nerve function
* Evaluation of complications

Before discharge

* Clinical assessment of facial nerve function and photo documentation
* Evaluation of complications occurring in the course of the procedure
* Postoperative AEP measurement and pure tone audiometry incl. speech discrimination

Outpatient follow-up after 3 months

* Evaluation of postoperative pure tone audiometry incl. speech discrimination
* Clinical assessment of facial nerve function and photo documentation

Objective:

Primary outcome: patients undergoing RIC will show better hearing 3 months postoperatively than the sham control group.

Secondary outcome hypothesis: patients undergoing RIC will show better postoperative facial nerve function than the sham control group before discharge and 3 months postoperatively.

group 1: intervention, remote ischemic preconditioning for 4x5 minutes at the beginning of the surgery group 2: sham-control (4x5 min without compression of the extremity)

only the study nurse who performs the intervention is aware of the study arm

Remote Ischemic Preconditioning in Vestibular Schwannoma Surgery

Remote Ischemic Preconditioning in Vestibular Schwannoma Surgery and Its Neuroprotective Effect on the Cochlear and Facial Nerve Function

IPD may be shared on request after completion of the study and as soon as data will be published.

hearing on pure tone audiometry according to AAO-HNS/Gardner-Robertson

activated partial thromboplastin time (aPTT)

Vertigo according to dizziness handicap inventory (=DHI, score 0-100, higher scores are associated with a higher burden of dizziness)

extent of schwannoma resection on the postoperative MRI

facial nerve function according to House and Brackmann

University Hospital Tuebingen

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Neurofibromatoses

Neurofibromatosis 1

Neurofibroma

Neurofibromatosis 2

Syndrome

Neoplastic Syndromes, Hereditary

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Peripheral Nervous System Diseases

Neuromuscular Diseases

Neurofibromatosis

Neurofibromatosis Type 1

Neurofibromatosis Type 2

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Everolimus

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

All subjects will be given RAD001 for 1 year (12 months).

Adults: 10 mg p.o. daily dose, age 16 - 17: 3.0 mg/m2 p.o. daily

RAD001, everolimus

Marco Giovannini, MD, PhD

The purpose of the study is to determine if RAD001 treatment will shrink or slow the growth of the vestibular schwannoma(s) in Neurofibromatosis 2 (NF2) patients. Secondary objectives include determining if RAD001 treatment will improve hearing ability in NF2 patients.

RAD001 is an oral drug that is approved by Food and Drug Administration (FDA) for other types of tumors, it is not approved by the FDA for treatment of NF2 related tumors.

This protocol is a Phase II, open-label, efficacy and safety study of single-agent RAD001 in patients with NF2. During the study, subjects will receive continuous daily oral treatment with RAD001 for up to 1 year or until tumor progression.

Primary Objective: To determine whether RAD001 has an effect on the VS growth in patients with NF2 at a rate sufficient to submit the drug for further testing.

Secondary Objectives: To determine whether RAD001 has an effect on the volume of other intracranial tumors, and to assess the effect of RAD001 on hearing function in patients with NF2 (when applicable).

Study of RAD001 for Treatment of NF2-related Vestibular Schwannoma

A Single Arm, Monocenter Phase II Trial of RAD001 as Monotherapy in the Treatment of Neurofibromatosis Type 2 - Related Vestibular Schwannoma

Determine the effect of RAD001 on change in vestibular schwannoma volume (mm3) by MRI from baseline to 1 year.

Determine the effects of RAD001 treatment on hearing changes (from baseline to 1 year in the ear with the growing vestibular schwannoma.

Determine the number of study subjects with adverse events by grade of severity

Novartis Pharmaceuticals

Jonsson Comprehensive Cancer Center

Respiratory Tract (Lung and Bronchial) Diseases

Hearing Loss

Deafness

Head and Neck Neoplasms

Hearing Disorders

Laryngeal Diseases

Sensation Disorders

Neurologic Manifestations

Respiratory Tract Diseases

Patients with head and neck conditions affecting hearing, balance, smell, taste, swallowing, voice and speech.

Marcia L Mulquin, R.N.

Joshua Levy, M.D.

Marcia Mulquin, RN, MSN

NIH Clinical Center Office of Patient Recruitment (OPR)

Background:

Many disorders of the head and neck can affect a person s hearing; balance; smell; taste; swallowing; voice; or speech. These disorders include cancers and genetic and inflammatory diseases. To find better ways to diagnose and treat these disorders, researchers need to study tissues and other biological samples from people who have them.

Objective:

To collect biological samples for a repository that will be used for research.

Eligibility:

People of any age with a disorder of the head and neck that requires the taking of biological samples. The conditions may be any that affect hearing; balance; smell; taste; swallowing; voice; or speech.

Design:

Part 1: Participants will give permission for their leftover tissue samples to be used for research. These are tissue samples from the head and neck that were collected in the course of routine tests and care or other research studies. Information on each participant s age, diagnosis, and previous treatments will also be collected.

Part 2: Some participants may be asked for more samples. All those aged 3 years or older will have a physical exam. They will provide blood and saliva samples. A cotton swab or brush will be used to collect cells from the inside of the cheek.

Participants 18 years or older may have additional tests. They may provide nasal secretions: A piece of gelfoam or a sponge will be placed in the nose to soak up secretions for 5 to 10 minutes. They may have biopsies: Small samples of tissue will be cut from the skin and the tissue lining the mouth.

Samples may be used for genetic testing.

Study Description:

National Institute on Deafness and Other Communication Disorders (NIDCD) investigators are studying the natural history and treatment of diverse conditions of the head and neck affecting hearing, balance, smell, taste, swallowing, voice and speech at the National Institutes of Health (NIH). These studies require the collection of biospecimens for research purposes.

Objectives:

Primary:

To create a biorepository of diseased and normal tissue specimens for research purposes. The samples will be obtained:

(Part 1) From surgical waste materials from participants of all ages in NIH protocols who have head and neck disorders.

(Part 2) Participants aged 3 and older may have collection of blood, saliva, and/or oral swabs. Participants aged 18 and older, may undergo oral mucosal biopsies and skin biopsies and nasal secretion collection, taken from subjects with head and neck disorders.

Secondary:

The specimens may be shared with the NCI Frederick Patient-Derived Xenograft (PDX) team, other approved protocols or may be used under this protocol to conduct analysis of cellular, molecular, genetic and genomic biology of normal processes and disorders. These laboratory studies may support development of future protocols that include new therapeutic agents, novel treatment approaches, and new prognostic and diagnostic models for subjects with disorders of the head and neck affecting human communication.

Endpoints:

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.

NIDCD Otolaryngology Clinical Protocol Biospecimen Bank

(Part 1) From surgical waste materials from participants of all ages in NIH protocols who have head and neck disorders.(Part 2) Participants aged 3 and older may have collection of blood, saliva, and/or oral swabs. Participants aged 18 and older, may undergo oral mucosal biopsies and skin biopsies and nasal secretion collection, taken from subjects with head and neck disorders.

These laboratory studies may support development of future protocols that include new therapeutic agents, novel treatment approaches, and new prognostic and diagnostic models for subjects with disorders of the head and neck affecting human communication

National Institute on Deafness and Other Communication Disorders (NIDCD)

Behaviors and Mental Disorders

Carcinoma

Communication Disorders

Neurobehavioral Manifestations

Neurodevelopmental Disorders

Mental Disorders

Psychotic Disorders

Patients at risk, suspected of having, have a history of, or currently have a diagnosed head and neck or communication disorder.

Clint T Allen, M.D.

Study Description:

It may be in the interest of the NIDCD Clinical Research Program (CRP) to collect clinical data or specimens generated in the diagnosis and treatment of head and neck or communication disorders and to evaluate patients to determine candidacy for intramural clinical studies. This protocol will provide the administrative vehicle to enable the evaluation and provision of clinical care for patients with head and neck and communication disorders by the NIDCD CRP, Clinical Center, and consult services. No investigational therapies will be administered in this

study.

Objectives and Endpoints:

(Summation)To collect clinical data or specimens generated in the diagnosis and treatment of head and neck or communication disorders

(Summation)To evaluate patients to determine candidacy for intramural clinical studies

Study Population:

Patients at risk, suspected of having, have a history of, or currently have a diagnosed head and neck or communication disorder referred to NIDCD Clinical Investigators by the Intramural Consult Service or community providers

Description of Sites:

NIH Clinical Center

Study Duration:

10 years

Collection of Clinical Data and Specimens for Research on Head and Neck and Communication Disorders

To evaluate patients to determine candidacy for intramural clinical studies

To collect clinical data or specimens generated in the diagnosis and treatment of head and neck or communication disorders

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Remote Ischemic Preconditioning in Vestibular Schwannoma Surgery	NCT05567341	Vestibular Schw...	Remote ischemic... Sham-control	18 Years -	University Hospital Tuebingen
Study of RAD001 for Treatment of NF2-related Vestibular Schwannoma	NCT01345136	Neurofibromatos... Neuroma, Acoust...	RAD001, everoli...	16 Years - 65 Years	Jonsson Comprehensive Cancer Center
NIDCD Otolaryngology Clinical Protocol Biospecimen Bank	NCT06303180	Hearing Loss Head and Neck N... Hearing Disorde... Laryngeal Disea...		3 Years - 99 Years	National Institutes of Health Clinical Center (CC)
NIDCD Otolaryngology Clinical Protocol Biospecimen Bank	NCT06303180	Hearing Loss Head and Neck N... Hearing Disorde... Laryngeal Disea...		3 Years - 99 Years	National Institutes of Health Clinical Center (CC)
Collection of Clinical Data and Specimens for Research on Head and Neck and Communication Disorders	NCT04618432	Head and Neck C...		2 Years -	National Institutes of Health Clinical Center (CC)
Study of RAD001 for Treatment of NF2-related Vestibular Schwannoma	NCT01345136	Neurofibromatos... Neuroma, Acoust...	RAD001, everoli...	16 Years - 65 Years	Jonsson Comprehensive Cancer Center

Spots Global Cancer Trial Database for hearing

Every month we try and update this database with for hearing 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 hearing

Every month we try and update this database with for hearing 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 hearing 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.