Dysphagia Rehabilitation for Nasopharyngeal Carcinoma Patients Post Radiotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In Hong Kong, every 30 and 12.9 in 100,000 males and females respectively has nasopharyngeal carcinoma (NPC). With early detection and advances in medical care, the number of NPC survivors post radiotherapy is rapidly growing in Hong Kong. One of the most distressing consequences post radiotherapy for NPC patients is swallowing disorder, or dysphagia. Dysphagia in NPC patients almost certainly cause frequent chest infection, dehydration, malnutrition and limitations to concurrent treatment such as oral medication. Given the existing large costs NPC patients incur to the healthcare system, dysphagia only serves to further inflate the soaring costs.

In an attempt to reduce dysphagia related costs to the healthcare system, swallowing rehabilitation is offered to NPC patients. Currently, two major swallowing rehabilitation approaches are commonly adopted. The first is traditional rehabilitation, which involves patients performing various oropharyngeal exercises aimed at improving swallowing physiology. The other swallowing rehabilitation approach is transcutaneous electrical stimulation, which entails using small amount of electric current to increase muscle strength while patients are engaged in swallowing activities. These two methods are proven as effective in patients with stroke and head and neck carcinoma patients. Neither of these methods, nevertheless, yields any efficacy studies in treating NPC patients. Yet, clinicians continue to use either one or both rehabilitation methods as swallowing rehabilitation.

This study aims to address the gap in efficacy studies on swallowing rehabilitation for NPC patients post radiotherapy. The research results should provide justification for rehabilitation time, clinicians' efforts, costs involved and resources used in rehabilitating the swallowing difficulties of the NPC patients.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Functional Electrical Stimulation in Irradiated Nasopharyngeal Carcinoma (NPC)

NCT00815087

Dysphagia

COMPLETED PHASE2

External Pharyngeal Exerciser for Dysphagia

NCT05267314

Pharyngeal Dysphagia Dysphagia Oral Pharyngeal Dysphagia

UNKNOWN NA

Radiation-Related Dysphagia Development Prediction Using a Two-Step Ultrasonographic Model (R-2D-2)

NCT06387004

Swallowing Disorders

RECRUITING

Pre-treatment Exercises Versus Post-treatment Exercises for Dysphagia

NCT00584129

Head and Neck Cancer

COMPLETED NA

Using the Subglottic Pressure to Predict the Dysphagia After Partial Laryngectomy

NCT06024980

Laryngeal Cancer Dysphagia

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nasopharyngeal Carcinoma Radiotherapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Traditional rehabilitation (TR)

Group Type ACTIVE_COMPARATOR

Traditional rehabilitation (TR)

Intervention Type BEHAVIORAL

TR rehabilitation will be scheduled three 45-minute sessions per week for 4 weeks with a total of 12 sessions that include Mendelsohn manoeuvre, Shaker's exercise, Effortful swallow and Masako manoeuvre.

Transcutaneous electrical stimulation (ES)

Group Type ACTIVE_COMPARATOR

Transcutaneous electrical stimulation (ES)

Intervention Type BEHAVIORAL

Subjects will receive three 45-minute sessions per week for 4 weeks with a total of 12 sessions.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Traditional rehabilitation (TR)

TR rehabilitation will be scheduled three 45-minute sessions per week for 4 weeks with a total of 12 sessions that include Mendelsohn manoeuvre, Shaker's exercise, Effortful swallow and Masako manoeuvre.

Intervention Type BEHAVIORAL

Transcutaneous electrical stimulation (ES)

Subjects will receive three 45-minute sessions per week for 4 weeks with a total of 12 sessions.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* able 18 years of age
* undergone primary radiotherapy or chemoradiotherapy as the treatment
* are expected to complete the 12 month follow-up

Exclusion Criteria

* prior history of head and neck surgery except biopsies of the NP or the neck nodes
* previous history or having a concurrent neoplasm other than NPC
* other severe medical problems that might contribute to dysphagia, e.g. cerebral vascular accident, neuromuscular diseases, respiratory diseases that may cause dysphagia
* present contraindications for the use of electrical stimulation which include pregnancy, pacemaker, other implanted electrodes or significant reflux
* non-oral feeding is contemplated in prior to treatment
* inability to complete the assessment including cognitive impairment
* of a low life expectancy related to NPC or other illnesses
* history of dysphagia prior to radiotherapy or chemoradiotherapy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No