Methylnatrexone In Resectable Head and Neck Squamous Cell Carcinoma (MINK). A "Window of O
To learn if OCSCC patients can be safely given methylnaltrexone for 2 weeks before surgery.
| Condition(s) | Head and Neck Squamous Cell Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | To learn if OCSCC patients can be safely given methylnaltrexone for 2 weeks before surgery. |
| Who can participate | Inclusion Criteria: * 18 years of age or older. Because no dosing or adverse event data are currently available on the use of methylnaltrexone in participants \<18 years of age, children are excluded from this study. * Histologically-confirmed oral cavity squamous cell carcinoma \[(T1-T4, N (any)\] that is amenable to curative-intent surgery * Able to receive the study drug for at least two weeks preoperatively * Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures * The effects of methylnaltrexone on the developing human fetus are unknown. For this reason and because methylnaltrexone agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | M.D. Anderson Cancer Center |
| Locations | Houston, Texas, United States |
| Start date | 2024-01-10 |
| NCT ID | NCT06162377 |
| Official listing | https://clinicaltrials.gov/study/NCT06162377 |