Study Results
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.
COMPLETED
NA
90 participants
INTERVENTIONAL
2013-06-30
2017-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect Of High Power Laser On Radiotherapy Induced Trismus.
NCT05757024
Eletric Stimulation for Hipossalivation Induced by Radiotherapy
NCT03151889
Acquisition of 3D Facial Geometry of Patients' Scheduled for Radiotherapy Treatment
NCT02930915
Effect of Triple Pre-rehabilitation on Radiotherapy for Head and Neck Cancer Patients
NCT05594069
Closed vs. Open Face Masks for Cranial Radiotherapy
NCT04079595
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Device Hyperboloid
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).
Hyperboloid
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).
Device Therabite
* 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).
Therabite
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).
Hyperboloid
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).
Control
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Therabite
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).
Hyperboloid
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).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* both male and female individuals, aged 18 or over;
* patients with a diagnosis of anatomopathological mouth and/or pharyngeal cancer;
* patients who have undergone radiotherapy only, or radiotherapy combined with surgery and/or chemotherapy;
* patients who have one or more muscles of mastication in the radiation field, and;
* patients who have scored more than 60% in the Karnofsky Performance Status.
Exclusion Criteria
* patients undergoing brachytherapy;
* patients undergoing physiotherapy intervention.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Irmandade Santa Casa de Misericórdia de Porto Alegre
OTHER
Federal University of Health Science of Porto Alegre
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Karoline Camargo Bragante
PT
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Geraldo P. Jotz, Ph.D
Role: STUDY_DIRECTOR
Federal University of Rio Grande do Sul - UFRGS
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Santa Rita - Santa Casa de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
RDC/TMD is widely used in the scientific and clinical practice for assessment of temporomandibular dysfunction
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
259.691
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.