Methylnatrexone In Resectable Head and Neck Squamous Cell Carcinoma (MINK). A "Window of Opportunity" Pilot Study.
Part of paid clinical trials in Houston, Texas.
- Sponsor
- M.D. Anderson Cancer Center
- Study ID
- NCT06162377
- Phase
- PHASE4
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Methylnaltrexone — DRUGGiven by SC (injection)
Study Details
To learn if OCSCC patients can be safely given methylnaltrexone for 2 weeks before surgery.
Key Dates
- Start date
- Jan 10, 2024
- Status verified
- Jun 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 25 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: MethylnaltrexoneParticipants will be given 14 pre-filled syringes of methylnaltrexone. Participants will be instructed how to take the drug as an injection under the skin of your abdominal area.
Primary Outcome Measure
Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year. ]
Central Contacts
- Juan Cata, MD(713) 792-7452
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| MD Anderson Cancer Center | Houston | Texas | 77030 | Juan Cata, MD (PRINCIPAL_INVESTIGATOR) |
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