About this trial
This trial looks at patients with resectable head and neck squamous cell carcinoma. The goal is to see if they can safely receive a medicine called methylnaltrexone for two weeks before their surgery. Researchers want to learn if this treatment is possible without causing problems. They will also check how well patients tolerate the medicine and how it affects their tumors.
The trial ID is NCT06162377. This is a Phase 4 study, which means it is looking at how well the treatment works and its safety. The study is FDA-regulated and aims to include around 25 participants.
Who can join
This trial is open to adults aged 18 and older. Participants must have a confirmed diagnosis of oral cavity squamous cell carcinoma that can be surgically treated. Those who can take the study drug for at least two weeks before surgery can join. Women who can become pregnant and men must agree to use birth control during the study. The trial team will confirm who can participate.
Condition
Head and Neck Squamous Cell Carcinoma
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
Everyone in the study will receive methylnaltrexone. They will get 14 pre-filled syringes and will learn how to give themselves injections under the skin of their abdomen. The trial focuses on how well participants can tolerate the medicine and whether it is safe to use before surgery.
Where
This trial is running at 1 location in the United States. It is currently recruiting.
MD Anderson Cancer Center
Houston, Texas