Neoplasms

All Conditions

Nervous System Diseases

Symptoms and General Pathology

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Musculoskeletal Diseases

Rare Diseases

Head and Neck Neoplasms

Trismus

Mouth Neoplasms

Oropharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Mouth Diseases

Muscle Cramp

Spasm

Neuromuscular Manifestations

Neurologic Manifestations

Oral Cancer

Lip and Oral Cavity Cancer

Wooden spatula

Hand held device placed in mouth that exercises the jaw

Therabite

Prof Slevin

The trial will compare exercises using Therabite® versus wooden spatulas to prevent or relieve trismus in patients with stage 3 and 4 oral/oropharyngeal cancer.

Trismus is defined as a tightening of jaw opening. The negative impact of Trismus on the quality of life of head and neck cancer patients is well established. It affects eating, drinking, speaking and social function and is often as debilitating as any disfigurement resulting from treatment.

The use of jaw exercises using a Therabite appliance following treatment has been shown to reduce the level of Trismus in small studies. Many UK centres, however, use stacked wooden spatulas inserted between the incisors as a means of passive exercise. There is anecdotal evidence that suggests the use of exercises prior to treatment may help reduce the severity of the Trismus experienced by the patient.

This study will enrol 112 head and neck cancer patients allocated by chance to use either the Therabite or wooden spatula and patients will be asked to perform mouth exercises on a daily basis for 6 months.

There is a need to evaluate both the clinical effectiveness and cost-effectiveness of Therabite as opposed to wooden spatulas to determine whether they should be adopted as standard care in head and neck cancer patients.

In this pilot trial, the investigators will measure benefits of Therabite to patients, as compared to usual care with wooden spatulas. Mouth opening will be the key outcome for the study.

Trismus Trial of Therabite vs Wooden Spatula in Head and Neck Cancer Patients

Randomised Pilot Study of Therabite® Versus Wooden Spatula in the Amelioration of Trismus in Head and Neck Cancer Patients. (Trismus Trial)

Willis bite calliper will be used to measure the jaw opening at baseline, 3 and 6 months

Adherence to device use will be captured by the patient on a progress log

Patients hospital and service use will be captured at Baseline, 3 and 6 months during interviews with the patient.

Units used will be days in hospital or number of appointments

The Christie NHS Foundation Trust

Brynn Chappell

Clinical Trials Project Manager

Wounds and Injuries

Fibrosis

Radiation Fibrosis Syndrome

Syndrome

Radiation Injuries

5 min of bilateral mastication alternated with the device hyperboloid The exercises should begin one day before the onset of Radiotherapy (RT) and kept until the end of RT.

Repeated 4x a day (after breakfast, lunch, dinner and before going to bed).

* 10 repetitions holding the device Therabite for 30 seconds
* 5 min of bilateral mastication alternated with the device hyperboloid The exercises should begin one day before the onset of Radiotherapy and kept until the end of RT.

Repeated 4x a day (after breakfast, lunch, dinner and before going to bed).

The control group (GEC) will not receive any of the protocols tested in the study, but together with the other groups, will receive the regular treatment offered by the institution, which is made up of guidance and advice given by the hospital´s nursing team about the radiotherapy treatment. Currently, patients do not receive any information as far as trismus is concerned.

10 repetitions holding Therabite for 30 seconds. The exercises should begin one day before the onset of Radiotherapy and kept until the end of RT. Repeated 4x a day (after breakfast, lunch, dinner and before going to bed).

5 min of bilateral mastication alternated with hyperboloid. The exercises should begin one day before the onset of Radiotherapy and kept until the end of RT. Repeated 4x a day (after breakfast, lunch, dinner and before going to bed).

Hyperboloid

Geraldo P. Jotz, Ph.D

The purpose of this study is to assess the effect of two protocols of physiotherapeutic exercises in the maintenance and/or increase of the mandibular range of movement in patients suffering from head and neck cancer (HNC) who are undergoing radiotherapy.

Because of contradictory data in the literature with regards to the efficiency of physiotherapeutic techniques to prevent and treat radiation-induced trismus, we believe there is a need to better investigate the efficiency and the quality of life resulting from the different prophylactic physiotherapeutic techniques for radiation-induced trismus in patients with HNC. After the conclusion of this research, we hope to suggest a suitable physiotherapeutic protocol to prevent this complication thereby allowing for an improvement in patients' quality of life.

Data collection:

All patients who begin Radiotherapy the Hospital will attend a group meeting with the nursing staff in order to receive information about their treatment. In the groups, we will identify patients who meet the study inclusion criteria and explain the Informed Consent Form. After we explain to patients their rights in accordance with resolution 196/96 of the National Health Council and they agree to take part by signing the consent form, we will begin gathering data.

The gathering of data will be done always by the same researcher, who will assess the patient twice; the first assessment will take place before the onset of radiotherapy treatment, preferably on the day that the patient undergoes simulation (baseline), the second assessment will take place immediately after the last session of radiotherapy (post radiotherapy), third assessment will take a place six months after radiotherapy and the late follow-up one year after the radiotherapy treatment. Each patient will have a different total duration of radiotherapy regarding the dosage of radiation and type of tumor. It is expected that the total duration of radiation will vary between 45 to 60 days.

Prior to that, all patients will be interviewed on a one-to-one basis in the premises of the Radiotherapy Service to provide their medical history. Other information such as tumor site, neoplastic histological type, staging,radiation field, dosage for each radiotherapy session, bilateral or unilateral presentation and aim of treatment (palliative or curative) will be taken from the patient's hospital records.

The physical examination will take place in accordance with the guidelines and specifications of the Research Diagnostic Criteria for Temporomandibular Disorders - RDC/TMD, which evaluates variables such as the range of motion of the temporomandibular joint (TMJ), joint sounds and level of pain when pressed by the fingers and to the mastication muscles. RDC/TMD is widely used in the scientific and clinical practice for assessment of temporomandibular dysfunction, as it has been officially translated into 18 languages, including Portuguese.

After recording the patient´s medical history and carrying out a physical examination, the patient will receive the University of Washington Quality of Life Questionnaire, version 4.

After undergoing assessment, patients will be given instructions about the physiotherapy exercises to be performed with the aid of an assistant physiotherapist. Patients will be randomly placed into 3 Groups.

The control group will not receive any of the protocols tested in the study, but together with the other groups, will receive the regular treatment offered by the institution, which is made up of guidance and advice given by the hospital´s nursing team about the radiotherapy treatment.

In order to assess patients' compliance with the protocol, they will be given a training calendar at baseline in order to record their compliance or not with the regime. Completed calendars will be collected at post radiotherapy.

Sample Size:

The sample size has been determined with the aid of the software PEPI (Programs for Epidemiologists) version 4.0 and based in the works of Tang et al.

(2011) and Buchbinder et al. (1993). In order to achieve a significance of 5%, a power of 90% and an effect size of one standard deviation amongst the groups, we have obtained a total of at least 23 patients in each of the 3 groups, with a grand total of 69 patients.

Randomization:

The randomization will be done by the software PEPI (Programs for Epidemiologists), subcategory RANDOM, which will draw the random numbers in each group. The allocation will be kept secret by the existence of a randomization list which will be kept in an isolated venue. The sequence of numbers to be used in the randomization will be kept confidential and will only be disclosed at the exact moment when intervention begins.

Statistical Analysis:

The quantitative variables will be described by standard deviation and mean while the qualitative variables will be described by absolute and relative frequency.

The Kolmogorov-Smirnov Test will be used to verify data normality. In order to compare intra and inter groups, the two-way Variable Analysis (ANOVA) for repeated measures with Bonferroni post-hoc test will be applied. In order to compare the means amongst the groups at the baseline, the one-way Analysis of Variance (ANOVA) with Tukey´s post-hoc will be used. If asymmetry is detected, we will apply the Kruskal-Wallis test supplemented by Mann-Whitney test.

In order to compare distribution, the Pearson chi-square test supplemented by the adjusted residuals will be applied. In order to compare the domains of Quality of Life, the Analysis of Variance (ANOVA) with Bonferroni post-hoc will be used for repeated measurements.

In order to assess the correlation between continuous variables, the Pearson linear correlation test will be used. If asymmetry is detected, the Spearman correlation will be applied.

The significance level adopted will be that of 5% (p\<0,05) and the analyses will be done using the software SPSS (Statistical Package for the Social Sciences) version 17.0.

Physiotherapy for Radiation-induced Trismus

Prophylactic Physiotherapy Development Of Radiation-Induced Trismus In Patients With Head And Neck Cancer: Randomized Controlled Clinical Trial

Mouth opening will be assessed before (baseline) and after total radiotherapy treatment (post radiotherapy) in order to establish if there have been any changes resulting from radiotherapy. The measure of mouth opening will be conducted with a pachymeter placed at the incisal edge of the superior and inferior incisor teeth. The maximal vertical distance, in millimeters, between the superior and inferior incisor teeth will be considered the total mouth opening of the patient.

Quality of life will be assessed by applying the UW-QOL Questionnaire, version 4, which is validated for the Brazilian population

Perfomance status will be assessed by applying Karnofsky Perfirmance Status

Mucositis will be graduated through World and Health Organization scale

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trismus Trial of Therabite vs Wooden Spatula in Head and Neck Cancer Patients	NCT01733797	Oropharyngeal C... Oral Cancer	Wooden spatula Therabite	18 Years -	The Christie NHS Foundation Trust
Physiotherapy for Radiation-induced Trismus	NCT02094690	Trismus Radiation-induc...	Therabite Hyperboloid	18 Years -	Federal University of Health Science of Porto Alegre
Physiotherapy for Radiation-induced Trismus	NCT02094690	Trismus Radiation-induc...	Therabite Hyperboloid	18 Years -	Federal University of Health Science of Porto Alegre

Spots Global Cancer Trial Database for therabite

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

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