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Opioid Receptor Antagonist

Methylnaltrexone for Head and Neck Squamous Cell Carcinoma

Phase 4
Recruiting
Led By Juan Cata, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights

Study Summary

This trial tests if OCSCC patients can safely take a medicine before surgery to reduce side effects.

Who is the study for?
This trial is for adults with confirmed oral cavity squamous cell carcinoma that can be surgically removed. Participants must be able to take methylnaltrexone for two weeks before surgery, follow the study plan, and use approved birth control. Excluded are those on other trials, with allergies to similar drugs, uncontrolled illnesses like kidney or liver disease, HIV patients not on effective therapy, mental/social issues affecting compliance, urgent surgeries needed, metastatic disease or brain tumors present.Check my eligibility
What is being tested?
The MINK study tests if it's safe to give methylnaltrexone to patients with head and neck cancer for two weeks before their surgery. The goal is to see how well they tolerate the drug in this short period.See study design
What are the potential side effects?
Methylnaltrexone may cause side effects such as stomach pain or cramps, nausea or vomiting; however specific side effects will be monitored during the trial given its pilot nature.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My oral cancer is confirmed and can be treated with surgery aimed at curing it.
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I can take the study medication for at least two weeks before surgery.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and adverse events (AEs)

Side effects data

From 2013 Phase 4 trial • 237 Patients • NCT00672477
34%
Abdominal pain
11%
Nausea
8%
Disease progression
8%
Diarrhea
8%
Fall
8%
Back pain
7%
Flatulence
6%
Confusional state
6%
Edema peripheral
4%
Vomiting
1%
Hyponatremia
1%
Gastric ulcer perforation
1%
Intestinal obstruction
1%
Colon cancer metastatic
1%
Hypercalcemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Methylnaltrexone Bromide

Trial Design

1Treatment groups
Experimental Treatment
Group I: MethylnaltrexoneExperimental Treatment1 Intervention
Participants 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylnaltrexone
2003
Completed Phase 4
~1840

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,451 Total Patients Enrolled
Juan Cata, MDPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
214 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open spots available for potential participants in this clinical trial?

"According to the data showcased on clinicaltrials.gov, this trial is not in the process of recruiting patients at present; it was initially published on April 30th 2024 and edited for the last time on November 30th 2023. Notwithstanding, there are 2764 other studies actively seeking volunteers currently."

Answered by AI

Has Methylnaltrexone been approved by the relevant governing body?

"There is ample evidence of Methylnaltrexone's safety and efficacy, which earned it a score of 3."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Methylnatrexone In Resectable Head and Neck Squamous Cell Carcinoma (MINK). A "Window of Opportunity" Pilot Study.
2024. "Methylnatrexone In Resectable Head and Neck Squamous Cell Carcinoma (MINK). A "Window of Opportunity" Pilot Study.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06162377.
~10 spots leftby Jun 2024
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