search
Back to results

Effects of Exercise Therapy Adjuvant Device on Head and Neck Cancer Patients in the Treatment of Cancer Therapy Induced Trismus

Primary Purpose

Maximum Interincisal Opening

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
exercise therapy plus jaw device
exercise therapy
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Maximum Interincisal Opening focused on measuring trismus, head and neck cancer, radiotherapy, maximum interincisal opening

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age is greater than or equal to 20 years old.
  2. Those who are able to communicate in Mandarin and Taiwanese and have no reading or listening or writing disabilities can fill out the questionnaire by themselves or with the assistance of the researcher.
  3. Diagnosed with head and neck cancer, and is expected to receive head and neck radiation therapy for the first time.
  4. A clear consciousness, no severe cognitive impairment or mental symptoms.
  5. Willing to participate in this research and obtain consent.

Exclusion Criteria:

  1. People with known temporomandibular joint disorders.
  2. The maximum opening degree is less than or equal to 25 mm.
  3. Those who have received radiotherapy for the head and neck in the past.
  4. Those who have been diagnosed by a physician for poor wound healing after surgery and unable to perform mouth-opening rehabilitation exercises.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    exercise therapy plus jaw device

    exercise therapy

    Arm Description

    exercise therapy plus jaw device

    exercise therapy

    Outcomes

    Primary Outcome Measures

    The change of maximum interincisal opening (MIO)
    Using Gothenburg Trismus Questionnaire, GTQ to measure the trismus condition and mouth opening

    Secondary Outcome Measures

    The change of fatigue level
    using the Brief Fatigue Inventory, BFI to measure fatigue level
    Quality of life (QOL)
    using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Head and Neck 35-questions, EORTC-QLQ-C30-H&N35 to meaure QOL

    Full Information

    First Posted
    February 2, 2021
    Last Updated
    February 4, 2021
    Sponsor
    Taipei Medical University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04740216
    Brief Title
    Effects of Exercise Therapy Adjuvant Device on Head and Neck Cancer Patients in the Treatment of Cancer Therapy Induced Trismus
    Official Title
    A Randomized Feasibility Trial to Test Exercise Therapy Plus Jaw Device to Prevent Trismus in Patients With Head and Neck Cancer Receiving Radiation-Based Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 10, 2021 (Anticipated)
    Primary Completion Date
    February 10, 2023 (Anticipated)
    Study Completion Date
    June 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Taipei Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Trismus is traditionally considered being a late effect of cancer therapy with functional deficits becoming clear in the first year after completing radiation therapy. These deficits can rapidly progress to a state of functional impairment. The most common treatment for trismus is physical therapy comprising an active range of motion (ROM) exercises, hold and relax techniques. Once trismus has developed, it may be hard to reverse. Thus, prevention with a program of self-care is important for managing this side effect. This study want to test the effect with adjunctive devices plus exercise to prevent trismus.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Maximum Interincisal Opening
    Keywords
    trismus, head and neck cancer, radiotherapy, maximum interincisal opening

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    130 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    exercise therapy plus jaw device
    Arm Type
    Experimental
    Arm Description
    exercise therapy plus jaw device
    Arm Title
    exercise therapy
    Arm Type
    Placebo Comparator
    Arm Description
    exercise therapy
    Intervention Type
    Behavioral
    Intervention Name(s)
    exercise therapy plus jaw device
    Intervention Description
    The mouth-opening rehabilitation exercise lasts for twelve weeks, five days a week, three times a day. Subjects can arrange to perform before or after meals according to personal eating time and preferences. The experimental group performs 30 minutes each time, including 20 minutes of stretching exercises. Ten-minute mouth expander assisted passive exercise.
    Intervention Type
    Behavioral
    Intervention Name(s)
    exercise therapy
    Intervention Description
    the control group performed 20-minute stretching exercises each time.
    Primary Outcome Measure Information:
    Title
    The change of maximum interincisal opening (MIO)
    Description
    Using Gothenburg Trismus Questionnaire, GTQ to measure the trismus condition and mouth opening
    Time Frame
    baseline, 2 weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, 12 weeks, 6 months.
    Secondary Outcome Measure Information:
    Title
    The change of fatigue level
    Description
    using the Brief Fatigue Inventory, BFI to measure fatigue level
    Time Frame
    baseline, 2 weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, 12 weeks, 6 months.
    Title
    Quality of life (QOL)
    Description
    using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Head and Neck 35-questions, EORTC-QLQ-C30-H&N35 to meaure QOL
    Time Frame
    baseline, 2 weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, 12 weeks, 6 months.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age is greater than or equal to 20 years old. Those who are able to communicate in Mandarin and Taiwanese and have no reading or listening or writing disabilities can fill out the questionnaire by themselves or with the assistance of the researcher. Diagnosed with head and neck cancer, and is expected to receive head and neck radiation therapy for the first time. A clear consciousness, no severe cognitive impairment or mental symptoms. Willing to participate in this research and obtain consent. Exclusion Criteria: People with known temporomandibular joint disorders. The maximum opening degree is less than or equal to 25 mm. Those who have received radiotherapy for the head and neck in the past. Those who have been diagnosed by a physician for poor wound healing after surgery and unable to perform mouth-opening rehabilitation exercises.

    12. IPD Sharing Statement

    Learn more about this trial

    Effects of Exercise Therapy Adjuvant Device on Head and Neck Cancer Patients in the Treatment of Cancer Therapy Induced Trismus

    We'll reach out to this number within 24 hrs