Evaluating a Low-Cost Therapeutic Device in Managing Head and Neck Cancer Patients With Radiation-Related Trismus

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Jan 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new, low-cost device designed to help patients with head and neck cancer who have difficulty opening their mouths due to radiation treatment. This condition, called trismus, can make it hard to eat, speak, and maintain good oral hygiene, which can affect overall health. The device is similar to a mouthpiece used for stretching the jaw, but it includes special sensors that measure how much pressure is being applied and how far the mouth can open. This information can help doctors tailor the treatment to each patient’s needs and encourage them to keep up with their exercises.

To join the trial, participants must be 18 years or older and have a diagnosis of radiation-induced trismus, which means they have trouble opening their mouths due to previous radiation therapy for head and neck cancer. They will need to provide written consent and be able to follow the study's requirements. This trial is currently recruiting participants, and it aims to improve the quality of life for those suffering from this condition by providing better management options.

Gender

ALL

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.