Evaluating a Low-Cost Therapeutic Device in Managing Head and Neck Cancer Patients With Radiation-Related Trismus
Trismus, Head and Neck Cancer
About this trial
This is an interventional supportive care trial for Trismus focused on measuring Radiation-related
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.
Sites / Locations
- University of California, San Francisco
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Part I (medical device usage, questionnaire)
Part II (medical device usage, mobile app usage)
Each participant will complete a single 45-minute visit in which consists of questionnaires about features that are important to them in trismus treatment, test a prototype of a trismus therapy device, and complete an online feedback questionnaire about their experience using the device.
Participants will be asked to use the device at least three times per week and up to daily for a period of 15-20 minutes over 6 weeks. Participants will be evaluated at baseline, at the 3-week (halfway) visit, and at the end of the 6-week treatment period under supervision of a speech language pathologist on study. Participants will then utilize a mobile app to help track treatment progress.