Digestive System Diseases

Ear, Nose, and Throat Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Neoplasms

Mouth and Tooth Diseases

Deglutition Disorders

Laryngeal Diseases

Laryngeal Neoplasms

Pharyngeal Neoplasms

Esophageal Diseases

Gastrointestinal Diseases

Pharyngeal Diseases

Otorhinolaryngologic Diseases

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Respiratory Tract Diseases

Respiratory Tract Neoplasms

Stomatognathic Diseases

Guillaume BUIRET, MD

A monocentric study to evaluate the french translation of Swallowing (SOAL-VF) Patient Reported Outcomes (PRO) after Total PharyngoLaryngectomy

the SOAL questionnaire is a validated Patient Reported Outcomes (PRO) questionnaire in English language.

The aim of this study is to develop a new tool in french language and to evaluate incidence and the specific impact of swallowing disorders on the quality of life of patients after Total PharyngoLaryngectomy.

Evaluation of the French Translation of Swallowing (SOAL-VF) Patient Reported Outcomes (PRO) After Total PharyngoLaryngectomy

Centre Hospitalier de Valence

Reactive intervention started promptly if/when dysphagia is identified (RE-ACTIVE)

Early low intensity proactive intervention started before RT commences

Early high intensity proactive intervention started before RT commences

Reactive intervention started promptly if/when dysphagia is identified

RE-ACTIVE

PRO-ACTIVE EAT

PRO-ACTIVE EAT + EXERCISE

Rosemary Martino, PhD

Kate Hutcheson, PhD

Dysphagia (difficulty swallowing) is a common and potentially life-threatening toxicity of radiotherapy (RT) for patients with head and neck cancer (HNC). HNC survivors have a 20-24 percent lifetime risk of pneumonia after RT, which is associated with a 42 percent excess risk of death in survivorship. Moreover, dysphagia predisposes individuals to malnutrition, and at least half of HNC patients require feeding tubes during RT.

Patients are commonly referred for swallowing therapy with a speech pathologist. Some patients receive early intervention, before a swallowing problem begins-PRO-ACTIVE therapy. Other patients are monitored and prescribed dysphagia interventions only if and when a swallowing problem occurs-RE-ACTIVE therapy. Thus, REACTIVE therapy aims to reverse an already impaired swallowing ability, whereas PRO-ACTIVE therapy aims to prevent or reduce severity of dysphagia. These two broad categories of therapy represent the most common types of intervention offered to HNC patients across North America. Although there is single-institution evidence to support each practice, it is yet unknown which is most effective.

To address this gap, the primary aim of this international, multi-site 3-arm pragmatic randomized clinical trial is to compare the effectiveness of PRO-ACTIVE (high and low intensity) versus RE-ACTIVE swallowing therapy among 952 patients with HNC planning to undergo RT, using duration of feeding tube dependence after RT as the primary outcome. Our secondary aim proposes to compare the relative benefit or harm of these swallowing interventions on secondary outcomes considered relevant to our stakeholder partners.

Swallowing therapy is commonly provided as a behavioral treatment to lessen the risk or severity of dysphagia in head and neck cancer (HNC) patients; however, best practice is not established. This multi-site, international randomized clinical trial (RCT) will compare the effectiveness of PRO-ACTIVE (high and low intensity) versus RE-ACTIVE swallowing interventions in 952 HNC patients undergoing radiotherapy (RT). The 3 study arms represent alternate timing and intensity of swallowing therapy delivered by a speech language pathologist: 1) RE-ACTIVE, 2) PRO-ACTIVE EAT, and 3) PRO-ACTIVE EAT + EXERCISE.

The primary aim of the PRO-ACTIVE trial is to compare the effectiveness of PRO-ACTIVE versus RE-ACTIVE swallowing interventions among patients with HNC planned to undergo RT. We hypothesize that the combined PRO-ACTIVE therapies are more effective than RE-ACTIVE therapy; and, if so, that more intensive PRO-ACTIVE (EAT + EXERCISE) is superior to less intensive PRO-ACTIVE (EAT). Effectiveness will be measured based on reduced duration of feeding tube dependency as the primary endpoint, an outcome valued equally by patients, caregivers and clinicians.

The secondary aim of the PRO-ACTIVE trial is to compare the relative benefit or harm of swallowing therapy arms on secondary outcomes including videofluoroscopic swallowing evaluations, functional status measures, health status measures, and patient-reported outcomes.

PRO-ACTIVE: Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer

PRO-ACTIVE: Comparing The Effectiveness of Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer

Effectiveness will be measured based on duration of feeding tube dependency (count of days from end of radiotherapy to last feeding tube use within the 12-month study period)

Measurement of swallowing-related Quality of Life

Measurement of severity or burden of cancer-related symptoms and interference with daily functioning.

Videofluoroscopy study score ranging from 0 to 5, where 4 is worst.

Videofluoroscopy study score ranging from 0 to 1, where 1 is worst.

Videofluoroscopy study score ranging from 1 to 8, where 8 is worst.

Videofluoroscopy study score ranging from 0 to infinity, where lower value is worse.

Measurement of swallowing and speech performance

Patient reported symptoms related to health consequences secondary to dysphagia, namely: malnutrition, aspiration pneumonia and mood changes such as depression and anxiety

Measurement of self-efficacy strategies for coping with cancer

Intake details, radiation therapy details, chemotherapy details, tumour status, surgery history, tracheotomy, feeding tube status, feeding tube dependence, concomitant therapies, and complication details.

All pain medications (including over-the-counter) taken in the past 48 hours

Hospitalization/ED presentation at cancer hospital or any external institutions

M.D. Anderson Cancer Center

Applied Health Research Centre

Qualitative Health Research Consultants, LLC

Patient-Centered Outcomes Research Institute

University Health Network, Toronto

Nervous System Diseases

Symptoms and General Pathology

Behaviors and Mental Disorders

Hearing Loss

Deafness

Stuttering

Developmental Disabilities

Communication Disorders

Language Disorders

Language Development Disorders

Speech Disorders

Neurobehavioral Manifestations

Neurologic Manifestations

Hearing Disorders

Ear Diseases

Sensation Disorders

Neurodevelopmental Disorders

Mental Disorders

Psychotic Disorders

Demographic Information Section on Knowledge \& Awareness Section on Practices

45 minutes presentation on Speech-Language Pathology introduction and scope Introduction to speech and language Introduction to a range of disorders The scope of practice

Speech-Language Pathology Presentation

Ayesha K Butt, PhD

There has been limited research in the area of speech and language therapy awareness in Pakistan. The study aims to assess the efficacy of providing speech therapy awareness in private schools through a pre-post model. This Quasi experimental study will be a means of reaching out to schools and directly create awareness regarding the field and its scope. Pre-assessment will be carried out and after which a 45 minutes presentation will be conducted face to face or through a webinar as per school directives. The results will be analysed quantitatively and pre-post assessment of the participants will be measured.

There has been limited research in the area of speech and language therapy awareness in Pakistan. The study aims to assess the efficacy of providing speech therapy awareness in private schools through a pre-post model. the study design is Quasi Experimental study

Sample size: 385. Raosoft Sampling technique: Purposive Sampling Inclusion criteria: Private English medium schools of Islamabad and Rawalpindi. Schools with no speech and language therapists Exclusion criteria: Public Schools and schools who may have visiting or permanent speech therapists on their panel.

Delphi technique will be used for development of a tool for the intervention and to assess the impact of the awareness program.

The teachers will be tested pre and post program and three months after the completion of the program. Three months post they will be a) tested on the same questionnaire b) will determine number of students identified with difficulties c) students referred to a therapist.

Data will be analyzed quantitative means and quantitative data will be analyzed using SPSS

Providing Speech Therapy Awareness in Private Schools

Effect of Providing Speech Therapy Awareness in Private Schools

A reliable and valid tool will be used for assessment of Knowledge, awareness and practice regarding the speech-language pathology profession and the scope of practice. The tool consists of demographic information, comprising of 45 questions, placed under 3 sections.

Riphah International University

Heart and Blood Diseases

Skin and Connective Tissue Diseases

Stroke

Ganglion Cysts

Synovial Cyst

Cysts

Mucinoses

Connective Tissue Diseases

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

All Drugs and Chemicals

Antipyretics

Anti-Inflammatory Agents

Antirheumatic Agents

Fibrinolytic Agents

Analgesics

Platelet Aggregation Inhibitors

Anticoagulants

Micronutrients

Hematinics

Anti-Infective Agents

Lipid Regulating Agents

Vitamins

Lidocaine

Aspirin

Vitamin B Complex

Vitamin B 12

Hydroxocobalamin

Ethanol

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Methylcobalamin

Vitamin B12

Cobalamin

Cyanocobalamin

Patients enrolled were firstly numbered for privacy with software and divided into the observation group (n=33) and the control group (n=33) with a random number table. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasted 20 days.

All the participants were provided with the comprehensive rehabilitation (routine rehabilitation and swallowing function training). The routine rehabilitation included intervention for risk factors (blood pressure, blood lipids, blood glucose, smoking and alcohol restriction, exercise, etc.) and pharmacological treatment (aspirin, statins, anticoagulants, etc.).

Regrading swallowing function training, both groups were given swallowing function training, including 1) exercises of closure of the vocal folds, pharyngeal, and laryngeal muscles exercises, and respiratory muscle strength training, for 15 min each time and twice per day. 2) isotonic／isometric swallowing exercises, supraglottic swallowing exercises, and the Mendelsohn maneuver, for 20 min each time and twice per day. 3) effortful swallowing exercises, and cough reflex training, for 10 min each time and twice per day.

comprehensive rehabilitation

the observation group was given SGB once a day, with 10 sessions as a course of treatment and each side of the body for one course. All the materials included: 1) 1.5ml of 2% Lidocaine hydrochloride injection (1ml: 0.5mg), Vitamin B12 Injection 500ug (1ml: 0.5g), the 5 ml disposable syringe and the sterile disposable dental injection needles. The specific operation procedure was as follows\[16\]: The operator stood at the patient\&#39;s block side, and the patient was placed in the supine position, with the head leaning 45 degrees toward the contralateral side of the block side. After routine disinfection of the skin, a paratracheal approach was adopted, which was, 2.5cm above the sternoclavicular joint and 1.5cm outside the midline of the neck.

Nieto Luis, Master

This was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group (n=33) or the control group (n=33). Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment, Kubota water swallowing test, video fluoroscopic swallowing study (VFSS), and Rosenbek penetration-aspiration scale (PAS) were used to assess swallowing function.

Dysphagia is a frequent and potentially serious complication of stroke. However, there is no effective measure for the treatment of pharyngeal dysphagia in stroke patients. This study aims to explore the efficacy of stellate ganglion block in post-stroke pharyngeal dysphagic patients who received comprehensive rehabilitation. This was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group (n=33) or the control group (n=33). Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment, Kubota water swallowing test, video fluoroscopic swallowing study (VFSS), and Rosenbek penetration-aspiration scale (PAS) were used to assess swallowing function.

Stellate Ganglion Block: A Breakthrough Treatment for Post-Stroke Pharyngeal Dysphagia

A Random Controlled Study to Explore the Effect of Stellate Ganglion Block on Post-Stroke Pharyngeal Dysphagia

The datasets generated and analyzed during the current study are not publicly available due to the hospital's confidentiality regulations regarding trial data but are available from the corresponding author on reasonable request.

The patient was required to take a sitting position with the head naturally upright. Under the guidance of the examiner, the patient first swallowed 5ml of iohexol solution (50ml:17.5g in iodine terms). If the patient exhibited aspiration, the test would stop. If not, the patient was instructed to swallow 10ml of iohexol solution mixed with breadcrumbs, and the patient's swallowing condition was observed with immediate measures ready to take for safety. Specially, the esophageal phase was not included in the study, because it was commonly regarded as an independent phase. The swallowing were divided into 3 phases in this assessment: Oral phase, Pharyngeal phase, and Aspiration, with maximum 3,3,4 points were given to each phase. The total score was calculated as the final result. The final score was positively correlated with the swallowing function.

During the test, patients were required to drink 30 ml of warm water. According to the situation, the swallowing function was rated from Level 1 (excellent) to Level 5 (poor). Specifically, Grade 1: The patient drank all the water at once without choking; Grade II: The patient drank all the water in two or more times without choking; Grade III: The patient drank all the water at once with choking; Grade IV: The patient drank all the water in two or more times with choking; Grade V: The patient exhibited difficulty drinking with frequent choking. Besides, we evaluated the efficacy as: 1) Recovery: The patient's symptoms of dysphagia disappear with grade 1 in the test. 2) Improvement: The patient shows improvement in dysphagia with the water the grade of the test improved. 3) Invalid: The patient's dysphagia deteriorates or did not improve, with the grade of the test not improved. (Overall effective rate = Recovery rate + Improvement rate).

Based on VFSS, this assessment evaluated the patient's swallowing of contrast medium and whether there was retention, penetration, and aspiration. It included multiple items, each with the corresponding criteria, Specifically, whether the swallowed material entered the airway, passed through or contacted the vocal cords, and whether the patient exhibited the corresponding ability to clear. There were 8 levels in the results, with higher levels indicating more severe aspiration.

Zeng Changhao

Infections

Carcinoma

Carcinoma, Squamous Cell

Papilloma

Pain

Virus Diseases

Squamous Cell Carcinoma of Head and Neck

Oropharyngeal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Quality of Life

Eligible patients with histologically verified early stage squamous cell carcinoma of the oropharynx.

Patients will be treated in accordance with current hospital protocols with transoral robotic surgery (T1-2, N1, M0) or radio(chemo)therapy (any T-stage, any N-stage, M0).

In the absence of severe mobidity patients with early stage disease (T1-2, N1, M0) were offered TORS, as an alternative to the standard of care (radiotherapy).

Primary Trans Oral Robotic Surgery (TORS)

As the standard of care radiotherapy was offered to all of the patients. Patients that qualified for both TORS and radiotherapy were free to choose between the two.

Radio(chemo)therapy

Christian von Buchwald, MD, dr. med.

To investigate the treatment related effects of transoral robotic surgery (TORS) or oncological treatment of oropharyngeal squamous cell carcinoma with a 1-year follow up.

Patients are enrolled prospectively at the department of Otorhinolaryngology, Head and Neck Surgery \& Audiology at Copenhagen University Hospital, Rigshospitalet.

All eligible patients with histologically verified squamous cell carcinoma of the oropharynx regardless of treatment option (as long as the intent is curative) can be included.

Outcome measures are assessed at baseline and repeated 3 and 12 months after treatment.

Saliva samples for later analysis of composition and changes in composition following treatment.

Functional Outcome After Treatment for Oropharyngeal Squamous Cell Carcinoma

Functional Outcome After Transoral Robotic Surgery (TORS) vs Oncological Treatment for Oropharyngeal Squamous Cell Carcinoma

Measured as change in flow rate or composition compared to baseline measurements performed prior to treatment.

Assessed using modified barium swallowing studies (MBSS). Evaluated as change from baseline.

Assessed using fiber endoscopic evaluation of swallowing function (FEES). Evaluated as change from baseline.

Assessed using the MD Anderson Dysphagia Inventory (MDADI) questionnaire. Evaluated as change from baseline.

Assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire. Evaluated as change from baseline.

Assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-H\&N35 questionnaire. Evaluated as change from baseline.

Assessed using a pain diary based on a 10 point visual analog scale (VAS). 0 being no pain and 10 the most severe pain. Registrered in increments of 1 (i.e. 3,5 is not an accepted score whereas 3 or 4 are).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of the French Translation of Swallowing (SOAL-VF) Patient Reported Outcomes (PRO) After Total PharyngoLaryngectomy	NCT05497947	Pharyngeal Canc... Swallowing Diso... Larynx Cancer		18 Years -	Centre Hospitalier de Valence
PRO-ACTIVE: Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer	NCT03455608	Dysphagia	RE-ACTIVE PRO-ACTIVE EAT PRO-ACTIVE EAT ...	18 Years -	University Health Network, Toronto
Providing Speech Therapy Awareness in Private Schools	NCT04505696	Speech and Lang... Speech Therapy Speech Delay Swallowing Diso... Acquired Langua... Developmental D... Stuttering Hearing Impairm... Head and Neck C...	Speech-Language...	-	Riphah International University
Stellate Ganglion Block: A Breakthrough Treatment for Post-Stroke Pharyngeal Dysphagia	NCT06189560	Dysphagia Stellate Gangli...	comprehensive r... SGB	30 Years - 80 Years	People's Hospital of Zhengzhou University
PRO-ACTIVE: Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer	NCT03455608	Dysphagia	RE-ACTIVE PRO-ACTIVE EAT PRO-ACTIVE EAT ...	18 Years -	University Health Network, Toronto
Providing Speech Therapy Awareness in Private Schools	NCT04505696	Speech and Lang... Speech Therapy Speech Delay Swallowing Diso... Acquired Langua... Developmental D... Stuttering Hearing Impairm... Head and Neck C...	Speech-Language...	-	Riphah International University
Functional Outcome After Treatment for Oropharyngeal Squamous Cell Carcinoma	NCT03418909	Oropharynx Canc... Pain Swallowing Diso... Quality of Life Saliva Altered Human Papilloma...	Primary Trans O... Radio(chemo)the...	18 Years -	Rigshospitalet, Denmark

Spots Global Cancer Trial Database for swallowing disorder