Physiotherapy for Radiation-induced Trismus

NCT02094690 | Completed DMC

• 1 other identifier: 259.691
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Trismus; Radiation-induced Fibrosis

Keywords

head and neck neoplasms; radiotherapy; physical therapy; trismus

Outcome Measures

Primary Outcomes (1)

• mouth opening in millimeters (mm)

  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.

  baseline (before radiotherapy), post radiotherapy (after the end of radiotherapy), 6 months follow-up and one year follow-up It is expected that the total duration of radiation will vary between a 45 to 60 days.

Secondary Outcomes (3)

• Quality of life

  baseline (before radiotherapy), post radiotherapy (after the end of radiotherapy), 6 months follow-up and one year follow-up It is expected that the total duration of radiation will vary between a 45 to 60 days.

• Performance status

  baseline (before radiotherapy), post radiotherapy (after the end of radiotherapy), 6 months follow-up and one year follow-up It is expected that the total duration of radiation will vary between a 45 to 60 days.

• Mucositis

  baseline (before radiotherapy), post radiotherapy (after the end of radiotherapy), 6 months follow-up and one year follow-up It is expected that the total duration of radiation will vary between a 45 to 60 days.

Study Arms (3)

Device Hyperboloid

ACTIVE COMPARATOR

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).

Device: Hyperboloid

Device Therabite

ACTIVE COMPARATOR

* 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).

Device: Therabite; Device: Hyperboloid

Control

NO INTERVENTION

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.

Interventions

Therabite DEVICE

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).

Device Therabite

Hyperboloid DEVICE

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 Hyperboloid; Device Therabite

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• signature of the Informed Consent Form;
• 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.

You may not qualify if:

• those with facial paralysis, trigeminal neuralgia and/or herpes zoster;
• patients undergoing brachytherapy;
• patients undergoing physiotherapy intervention.

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead
• Irmandade Santa Casa de Misericórdia de Porto Alegre: collaborator

Study Sites (1)

Hospital Santa Rita - Santa Casa de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90.020-090, Brazil

Location

Related Links

• RDC/TMD is widely used in the scientific and clinical practice for assessment of temporomandibular dysfunction

MeSH Terms

Conditions

Trismus; Radiation Fibrosis Syndrome; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fibrosis; Pathologic Processes; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Neoplasms

Study Officials

• Geraldo P. Jotz, Ph.D

  Federal University of Rio Grande do Sul - UFRGS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT

Study Record Dates

• First Submitted: July 12, 2013
• First Posted: March 24, 2014
• Study Start: June 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2017
• Last Updated: January 4, 2019

Record last verified: 2019-01

Locations

BR (1)