To hear about similar clinical trials, please enter your email below
Trial Title:
Evaluating a Low-Cost Therapeutic Device in Managing Head and Neck Cancer Patients With Radiation-Related Trismus
NCT ID:
NCT05671861
Condition:
Trismus
Head and Neck Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Trismus
Conditions: Keywords:
Radiation-related
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Trismus Device Prototype
Description:
Device is noninvasive and will be inserted between patient's upper and lower teeth
Arm group label:
Part I (medical device usage, questionnaire)
Arm group label:
Part II (medical device usage, mobile app usage)
Other name:
Medical Device
Intervention type:
Other
Intervention name:
Questionnaires
Description:
Surveys will be administered to participants
Arm group label:
Part I (medical device usage, questionnaire)
Other name:
Survey Administration
Intervention type:
Other
Intervention name:
Mobile Application
Description:
A study-specific, accompanying secure mobile application for users to track progress will
be created.
Arm group label:
Part II (medical device usage, mobile app usage)
Other name:
Mobile App
Summary:
This trial evaluates how well a new therapeutic device works in managing trismus in
patients who received radiation treatment for head and neck cancer. Radiation therapy is
a common form of treatment in patients with head and neck cancers. However, changes to
surrounding tissue following radiation therapy may lead to trismus, an inability to open
the mouth fully. This can create significant functional impairment leading to
malnutrition due to impaired chewing, risk of dental infections due to impaired oral
hygiene, difficulty with speech, and decreased health-related quality of life. Exercise
therapy is the mainstay of treatment for post-radiation trismus to help improve mobility
and flexibility and increase range of mouth opening. This new device is non-invasive and
is similar to other jaw stretching devices where a mouthpiece is placed between the teeth
and a hand-lever is used to spread open the upper and lower jaw. However, it will also
have additional sensors to measure pressure exerted by the hands and jaw as well as the
distance to open the mouth which could help guide therapy. This study may help doctors
customize a device to patient-specific needs, provide real-time feedback, and encourage
compliance for trismus exercise therapy.
Detailed description:
PRIMARY OBJECTIVE:
I. To assess the clinical efficacy of the trismus device, as measured by the change in
maximum interincisal opening over the six-week treatment period.
SECONDARY OBJECTIVE:
I. To assess participants compliance rates and jaw opening pressures when using this
device.
OUTLINE: Participants are assigned to 1 of 2 parts.
PART I: Participants test the trismus device and complete questionnaires on study.
PART II: Participants undergo exercise therapy with the trismus device under supervision
of a speech language pathologist on study.
Participants will be on study for up to 6 weeks with a follow-up visit 7 days after
completion.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Male or female >= 18 years of age at visit 1.
- Documentation of a radiation-induced trismus diagnosis as evidenced by one or more
clinical features consistent with the trismus phenotype (maximum interincisal
opening (MIO) < 35 mm) and a history of head and neck radiation
- Written informed consent (and assent when applicable) obtained from subject or
subject's legal representative and ability for subject to comply with the
requirements of the study.
Exclusion Criteria:
- Presence of a condition or abnormality that in the opinion of the investigator would
compromise the safety of the patient or the quality of the data.
- Minors (age < 18 years) or patients with inability to provide informed consent.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California, San Francisco
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Contact:
Last name:
Arushi Gulati, MD
Phone:
877-827-3222
Email:
Arushi.Gulati@ucsf.edu
Contact backup:
Email:
cancertrials@ucsf.edu
Investigator:
Last name:
Andrea Park, MD
Email:
Principal Investigator
Start date:
December 30, 2024
Completion date:
March 31, 2028
Lead sponsor:
Agency:
University of California, San Francisco
Agency class:
Other
Collaborator:
Agency:
Mount Zion Health Fund
Agency class:
Other
Source:
University of California, San Francisco
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05671861