Neoplasms

All Conditions

Nervous System Diseases

Symptoms and General Pathology

Behaviors and Mental Disorders

Head and Neck Neoplasms

Speech Disorders

Language Disorders

Communication Disorders

Neurobehavioral Manifestations

Neurologic Manifestations

In outpatients clinic, the first group consists of 60 head and neck cancer patients who were treated by ours. The participants will given the document consists that "bit, bet, but" words and also a brief part of "Diyet passage" who written by Omer Seyffettin. The speech record of patients who read to document, will evaluated by three judges (otorhinolaryngologist). Three judges will scoring to Turkish translation of London Speech Evaluation Scale (LSE-T), consists of 6 parameters. After the six weeks, the records were scored again as randomisely.

In outpatients clinic, the control group consists of 60 patients who have not speech and hear impairments. The participants will given the document consists that "bit, bet, but" words and also a brief part of "Diyet passage" who written by Omer Seyffettin. The speech record of patients who read to document, will evaluated by three judges (otorhinolaryngologist). Three judges will scoring to Turkish translation of London Speech Evaluation Scale (LSE-T), consists of 6 parameters. After the six weeks, the records were scored again as randomisely.

The document consists "bit, bet, but" words and Diyet passage. Volunteers will read the document in front of the microphone and also the speech will recorded by a computer.

The speech records related to the reading document

Ziya Salturk, Asso Prof,MD

Purpose of the study is the validation and cultual adaptation of the Turkish translation of the London Speech Evaluation Scale (LSE-T), so that it would be used as an assessment tool for Turkish head and neck cancer patients. There is no validated Turkish version of LSE to measure severity of perceptual speech in head and neck cancer patients.

The speech function is a multidirectional process that depends on complex neuro-muscular network. The function can be evaluated using instrumental, such as voice analysis computer programmes, scales, or well structured questionnaires. There are many scales for assessment of perceptual speech but there is no validated for head and neck patients. The study will assess the construct validity and adaptation of the Turkish translation of Speech Specific Perceptual Speech Evaluation as known as London Speech Evaluation Scale. The investigators developed the Turkish translation of this scale (LSE-T), according to the cross-cultural adaptation guidelines. Two translators translated the LSE into Turkish and a native English language speaker reverse-translated it into English. The back translation was sent to the original author for proofreading. The LSE scale consisted of 6 parameters and 4 scores related with perceptual speech in head and neck cancer patients.

Validation of the Turkish Translation of the London Speech Evaluation Scale

Validation and Cultural Adaptation of the Turkish Translation of the London Speech Evaluation Scale

Turkish Translation of London Speech Evaluation Scale consists of 6 parameters and 4 scores. The minimum score is 0 and maximum score is 24. The lower scores mean a better than high scores.

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Associate Professor, M.D.

Digestive System Diseases

Ear, Nose, and Throat Diseases

Mouth and Tooth Diseases

Deglutition Disorders

Esophageal Diseases

Gastrointestinal Diseases

Pharyngeal Diseases

Otorhinolaryngologic Diseases

Participants in this Arm will receive the current standard of care, which includes a referral to SLP in response to suspicion of a swallowing problem from either assessment by the medical team and/or patient report.

Participants in this Arm will receive the ESSI-SURG behavioural intervention by a live SLP.

Patients will receive 3 face-to-face sessions with a speech-language pathologist (SLP), each with a specific goal, namely: pre-surgical educational, a post-operative day 3 therapy, and post-operative day 7 therapy. Following discharge from hospital, participants will be seen by an SLP for 4 weekly sessions, offered via telehealth or face-to-face depending on the patient's clinic schedule and/or availability.

ESSI-SURG

Participants will receive the current standard of care, which includes a referral to SLP in response to suspicion of a swallowing problem from either assessment by the medical team and/or patient report.

Standard-of-Care

Trixie Reichardt, MHSc

Rosemary Martino, PhD

Jonathan Irish, MD

Oral cavity cancer (OCC) is one of the most common cancers worldwide, with tongue cancer being one of the most common subtypes. Patients with oral cancers can experience painful swallowing, swallowing difficulty (dysphagia), and associated weight loss long after surgery. Not only is dysphagia an independent predictor of quality of life (QoL) in cancer survivorship, it can also have a devastating impact on the health of patients resulting from complications such as pneumonia, malnutrition and feeding tube dependence. Emerging evidence suggests that patients undergoing surgery benefit from engaging with speech-language pathologists (SLPs) before problems arise, to learn swallow strategies that may become useful in their rehabilitation. This in turn has the potential to reduce complications and minimize the length of feeding tube dependency.

This study will assess the feasibility of conducting a prospective clinical trial that would evaluate the effects on patient health, function and overall benefit of early and systematic SLP speech and swallowing intervention for head and neck cancer patients planned for curative surgical treatment. We will also assess long-term changes in select clinical and patient-reported outcomes comparing their status before, and one month after, treatment.

Feasibility of Early Swallowing and Speech Intervention for Head and Neck Cancer Patients Treated SURGically

Feasibility success will be defined as the following across all patients and compared by arm: an accrual rate \>90%.

Feasibility success will be defined as the following across all patients and compared by arm: an attrition rate of \<10%.

Feasibility success will be defined as the following across all patients and compared by arm: data fidelity rate of \>80% for clinical assessments.

Feasibility success will be defined as the following across all patients and compared by arm: data fidelity rate of \>90% for patient reported outcomes.

University Health Network, Toronto

Principal Investigator

Infections

Musculoskeletal Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Bell Palsy

Facial Paralysis

Facies

Paralysis

Xerostomia

Polymyositis

Pharyngeal Neoplasms

Laryngeal Diseases

Dysarthria

Otorhinolaryngologic Neoplasms

Myositis

Muscular Diseases

Neuromuscular Diseases

Stomatognathic Diseases

Bell's Palsy

Idiopathic Inflammatory Myopathy

This study will assess the use of ultrasound-a test that uses sound waves to produce images-as a diagnostic tool for evaluating speech and swallowing.

The following categories of individuals may be eligible for this study: 1) healthy volunteers between 20 and 85 years old with normal speech and hearing, 2) patients 6 to 85 years old with developmental neurological deficits in speech or swallowing, and 3) patients with tumors of the oral cavity, pharynx or larynx being treated at the Greater Baltimore Medical Center.

Participants will undergo a 30-minute speech and oral motion evaluation, in which they imitate sounds, words and oral movements while a speech pathologist evaluates their lip, tongue and palate movements. They may also be asked to drink a small amount of water for examination of swallowing function.

For the ultrasound examination, a 3/4-inch transducer (device for transmitting and receiving sound waves) is placed under the participant's chin. While the transducer is in place, the subject 1) repeats sounds and a series of syllables in several sequences, 2) swallows three times with and without a small amount of water, and 3) swallows 3 teaspoons of non-fat pudding. The ultrasound images are recorded on tape for later analysis.

Studies conducted using ultrasound imaging at the NIH, Departments of Rehabilitation Medicine and Diagnostic Radiology, have demonstrated that ultrasound imaging can be used reliably to study speech and swallowing impairments in a variety of conditions and diseases. Since ultrasound is non-invasive with no reported bioeffects, it can be used repeatedly to follow the progression of a disease. Ultrasound imaging of the oral cavity during speech and swallowing allows easy visualization of the tongue/hyoid bone motion and transport of the bolus during swallowing and tongue surface configuration during speech. Images can be obtained in several planes for viewing muscular coordination and timing and specific measures can be obtained from digitized video images. Thus it has widespread clinical research implications for patients with disorders affecting the oral peripheral muscles, salivary gland flow and the central nervous system control of speech and swallowing. While ultrasound technology has been used extensively in Europe to evaluate tumors of the head and neck, its use in this country has been marginal. We plan to compare ultrasound evaluation of tumor staging, tumor volume, and tumor recurrence in patients with tumors of the larynx, oral cavity and hypopharynx. Currently, this is accomplished by CT or MRI scanning procedures. We plan to compare CT/MRI results with ultrasound to determine if this non-invasive technique can be utilized reliably for diagnosis and tracking of oropharyngeal tumors.

Ultrasound Evaluation of Tongue Movements in Speech and Swallowing

Exploration of the Diagnostic Capabilities of Ultrasound of the Oropharynx and Larynx

National Institutes of Health Clinical Center (CC)

Hearing Loss

Deafness

Hearing Disorders

Ear Diseases

Sensation Disorders

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)

Pain

Ulcer

Stomatitis

Mucositis

Gastroenteritis

Mouth Diseases

Quality of Life

Gastrointestinal Agents

Lipid Regulating Agents

All Drugs and Chemicals

Herbal and Botanical

Betaine

Hypolipidemic Agents

Antimetabolites

Olive

Patients 6 months after oncological treatment is finished

Topical composition in the form of a gel.

Composition comprising olive oil, xylitol and betaine

Beatriz Rodríguez-Vilaboa del Cura

PROMs questionnaires seem to be an effective tool to obtain a greater knowledge of the physical and emotional state of patients. Despite this, few studies have been performed using patient reported outcomes in Head \& Neck (H\&N) cancer patients during and after treatment. The use of a novel topical mucosa composition (Saliactive®) is studied along the use of questionnaires.

This study analyses the severity of oral mucositis of H\&N cancer patients along the first 6 weeks of radiotherapy with or without chemotherapy (Phase 1).

Phase 2 evaluates Quality of Life in a pool of H\&N cancer patients 6 months after cancer treatment is completed. Quality of life of patients is analysed before (baseline) and after 1 month period of use of the tested composition (Saliactive®) begining 6 months after oncological treatment completion.

During cancer treatment (Phase 1), mucositis may affect the course of therapy and long-term survival, while after treatment (Phase 2) chronic pain, xerostomia, dysphagia and speech limitations between others are behind anxiety and poor quality of life.

The WHO oral mucositis scale together with a structured qualitative questionnaire to recover patient reported symptoms are used during phase 1.

A validated Quality of Life questionnaire described by the University of Washington, is chosen for Phase 2 evaluation.

Oral mucosa management is homogenized both during acute and chronic phase with the use of a composition (Saliactive®) which comprises olive oil, betaine and xylitol delivered in the form of a topical non-rinsing gel.

Single group, interventional, open-label study.

Oral Mucositis and Quality of Life With a Mucosa Topical Composition in Head & Neck Cancer Patients.

Use of PROMs in Conjunction With a Mucosa Topical Composition to Evaluate Oral Mucositis During Cancer Treatment and Post-treatment QoL in H&N Cancer Patients. An Interventional Two Phases Study, Part of the Stop Mucositis Project.

Frequency of severe oral mucositis (grades 3-4) measured with the WHO scale during the 6 weeks of radiotherapy.

Oral mucositis was objectively assessed by clinician, based on observation of mucosa tissue damage, from grade 0 (no tissue injury), grade 1 (presence of erythema), grade 2 (presence of ulcers with or without erythema), grade 3 (confluent ulceration) to grade 4 (deep ulcerations and/or necrotic injury) at weekly intervals along the 6 weeks of radiotherapy.

Subjective assessment was also measured from patient reported outcomes regarding pain and difficulties in swallowing, from grade 0 (no pain, nor difficulty in swallowing), grade 1 (soreness but not difficulty in swallowing), grade 2 (moderate pain but able to eat solids), grade 3 (severe pain and not able to eat solids) to grade 4 (extreme pain and unable to oral diet) at the same time as the clinician measurement.

Frequency of severe oral mucositis (grades 3-4) were analysed at the end of the treatment.

Time to severe oral mucositis (grades 3-4) was analysed from clinically objective data and also from patient reported subjective symptoms registered week per week.

Comparison of late symptoms perceived by the patient through the PROMs validated Spanish version of the University of Washington Quality of Life questionnaire (UW-QOL) before (baseline) and after 1 month using the tested composition, starting 6 months after radiotherapy completion.

The UW-QOL questionnaire was filled by patients at baseline and after 1 month of use of the tested composition where the possible response options (from 3 to 6) to the 12 single question domains, were scaled evenly from 0 (worst) to 100 (best) according to the hierarchy of response.

The WHO scale was used by clinician to objectively assess oral mucositis grade based on physician's observation of mucosa tissue damage along the 6 weeks of radiotherapy. Oral mucositis severity was graded from grade 0 (no tissue injury), grade 1 (presence of erythema), grade 2 (presence of ulcers with or without erythema), grade 3 (confluent ulceration) to grade 4 (deep ulcerations and/or necrotic injury). Patient reported outcomes, regarding pain and difficulties in swallowing, from grade 0 (no pain, nor difficulty in swallowing), grade 1 (soreness but not difficulty in swallowing), grade 2 (moderate pain but able to eat solids), grade 3 (severe pain and not able to eat solids) to grade 4 (extreme pain and unable to oral diet), were recovered during an interview at time of visit to the unit at weekly intervals along the 6 weeks of radiotherapy.

Evaluation of possible differences between objective and subjective data was performed.

Frequency of severe oral mucositis (grades 3-4) were to be assessed in patients receiving radiotherapy and patients receiving al chemotherapy.

Evaluation of possible differences between patients receiving radiotherapy and patients receiving also chemotherapy data was performed.

Mucosa Innovations, S.L.

Brain Neoplasms

Epilepsy

Brain Diseases

Central Nervous System Diseases

Participants listened to 25-minute Speech Tasks while ECoG signals for neural activity was recorded during their intraoperative procedure or inpatient hospitalization at the University of California, San Francisco (UCSF).

Listen to 25-minutes of speech sounds in English.

Speech Tasks

Edward F Chang, MD

The basic mechanisms underlying comprehension of spoken language are still largely unknown. Over the past decade, the study team has gained new insights to how the human brain extracts the most fundamental linguistic elements (consonants and vowels) from a complex and highly variable acoustic signal. However, the next set of questions await pertaining to the sequencing of those auditory elements and how they are integrated with other features, such as, the amplitude envelope of speech. Further investigation of the cortical representation of speech sounds can likely shed light on these fundamental questions. Previous research has implicated the superior temporal cortex in the processing of speech sounds, but little is known about how these sounds are linked together into the perceptual experience of words and continuous speech. The overall goal is to determine how the brain extracts linguistic elements from a complex acoustic speech signal towards better understanding and remediating human language disorders.

Intracranial high-density electrodes make it possible to record neural activity directly from the brain surface with unparalleled spatial and temporal resolution to unravel both local and population encoding of speech sounds. This study proposes to assess speech perception in patients who are undergoing surgery for seizure localization or awake intraoperative brain mapping. Electrode placement is based on the clinical needs of each patient. The research study team will examine the mechanisms of phonetic encoding to reveal both the organization of auditory speech feature selectivity and the distributed population-level processing that give rise to the emergent properties of spoken language perception. The aims of this study seeks to determine the cortical encoding of phonological sequencing (Aim 1), representation of amplitude landmark coding in speech (Aim 2), and the shared and distinct mechanisms for speech and music melody encoding (Aim 3). Together, these aims will advance our understanding of speech encoding in the human brain beyond consonants and vowels, addressing questions pertaining to sequencing, amplitude coding, and auditory specialization. These results should heavily impact current theories of speech processing and, therefore, will have significant implications for understanding and remediating human language disorders.

Functional Organization of the Superior Temporal Gyrus for Speech Perception

Number of participants with ECoG signals for neural activity identified during intraoperative procedure or inpatient hospitalization, between 10-30 minutes.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Validation of the Turkish Translation of the London Speech Evaluation Scale	NCT04690166	Speech Intellig... Speech Disorder... Head and Neck C... Speech Dysfunct... Speech	The speech reco...	18 Years - 70 Years	Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Feasibility of Early Swallowing and Speech Intervention for Head and Neck Cancer Patients Treated SURGically	NCT06192771	Dysphagia Head and Neck C...	ESSI-SURG Standard-of-Car...	18 Years -	University Health Network, Toronto
Ultrasound Evaluation of Tongue Movements in Speech and Swallowing	NCT00001167	Otorhinolaryngo... Otorhinolaryngo... Pharyngeal Neop... Polymyositis Speech Disorder		-	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)
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)
Feasibility of Early Swallowing and Speech Intervention for Head and Neck Cancer Patients Treated SURGically	NCT06192771	Dysphagia Head and Neck C...	ESSI-SURG Standard-of-Car...	18 Years -	University Health Network, Toronto
Oral Mucositis and Quality of Life With a Mucosa Topical Composition in Head & Neck Cancer Patients.	NCT05635929	Oral Mucositis Quality of Life Mucositis Pain Speech Saliva Radiation Toxic... Chemotherapeuti...	Composition com...	18 Years -	Mucosa Innovations, S.L.
Oral Mucositis and Quality of Life With a Mucosa Topical Composition in Head & Neck Cancer Patients.	NCT05635929	Oral Mucositis Quality of Life Mucositis Pain Speech Saliva Radiation Toxic... Chemotherapeuti...	Composition com...	18 Years -	Mucosa Innovations, S.L.
Oral Mucositis and Quality of Life With a Mucosa Topical Composition in Head & Neck Cancer Patients.	NCT05635929	Oral Mucositis Quality of Life Mucositis Pain Speech Saliva Radiation Toxic... Chemotherapeuti...	Composition com...	18 Years -	Mucosa Innovations, S.L.
Functional Organization of the Superior Temporal Gyrus for Speech Perception	NCT05435859	Epilepsy Brain Tumor Speech	Speech Tasks	18 Years - 70 Years	University of California, San Francisco

Spots Global Cancer Trial Database for speech

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

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