Evaluating a new device for managing mouth opening in head and neck cancer patients after radiation
Design of a Low-Cost Therapeutic Device for Patients With Radiation-Related Trismus
This study is testing a new, affordable device to help people with head and neck cancer who have trouble opening their mouths after radiation treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT05671861 on ClinicalTrials.gov |
What this trial studies
This trial assesses the effectiveness of a low-cost therapeutic device designed to manage trismus in patients who have undergone radiation treatment for head and neck cancer. Trismus, characterized by limited mouth opening, can lead to significant functional impairments, including difficulties with eating and speaking. Participants will use the device over a six-week period, with assessments of jaw opening and compliance rates. The study includes both self-administered and supervised exercise therapy to enhance treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a documented diagnosis of radiation-induced trismus following head and neck cancer treatment.
Not a fit: Patients with conditions that compromise their safety or data quality, or those under 18 years of age, may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly improve mouth opening and quality of life for patients suffering from radiation-related trismus.
How similar studies have performed: Other studies have shown promise in using similar therapeutic devices for managing trismus, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Andrea Park, MD — University of California, San Francisco
- Study coordinator: Arushi Gulati, MD
- Email: Arushi.Gulati@ucsf.edu
- Phone: 877-827-3222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.