Can a constipation drug help head and neck cancer patients before surgery?

NCT ID NCT06162377

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a drug called methylnaltrexone is safe for people with head and neck cancer when taken for two weeks before their surgery. The drug is already used for constipation, but researchers want to see if it can be given safely in this setting. About 25 adults with oral cavity cancer that can be removed by surgery will take part.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the participants presents with an applicable exclusionary factor which may be one of the following: * Postmenopausal (no menses in greater than or equal to 12 consecutive months). * History of hysterectomy or bilateral salpingo-oophorectomy. * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy). * History of bilateral tubal ligation or another surgical sterilization procedure. * Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while her partner participates in this study, she should inform her treating physician immediately. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Participants who are receiving any other investigational agents. * Non-English/Non-Spanish speaking participants. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to methylnaltrexone or other agents used in the study. * Participants with uncontrolled intercurrent illness, including chronic kidney disease defined as a eGRF \<60 ml/mim, and liver disease defined as transaminitis \> 2 folds from normal levels, cirrhosis and hyperbilirubinemia \> 2 folds from normal levels * Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. * Participants with psychiatric illness/social situations that would limit compliance with study requirements. * Urgent or emergency surgery * Participants with known distant metastatic disease * Participants with primary brain tumors or brain metastases. Methylnaltrexone has poor penetration of the blood brain barrier and there is limited available data regarding the safety of the drug in participants with central nervous system tumors. * Pregnant women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with methylnaltrexone, breastfeeding should be discontinued if the mother is treated with methylnaltrexone. These potential risks may also apply to other agents used in this study. * Peptic ulcer or intestinal perforation or colitis or other intestinal disorders such as Crohn's disease, diverticulitis, or Ogilvie's syndrome, intestinal obstruction or severe diarrhea because of risk of intestinal perforation. * Use of other opioid antagonists because of the potential for additive effects of opioid receptor antagonism and increased risk of opioid withdrawal.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

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