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Could a cheap gout pill soothe radiation burns?

NCT ID NCT05335148

Symptom relief Sponsor: Rutgers, The State University of New Jersey Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Summary

This early-stage study tests whether a low dose of colchicine, a medicine usually used for gout, can safely reduce skin redness and pain caused by radiation therapy in people with head and neck cancer. About 30 participants take one pill daily during their radiation treatment. The goal is to see if this approach can ease a common side effect that currently has no approved treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

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

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 30 people

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

Started

May 2022

Expected to finish

Jun 2027

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: * Eight years or older with HNC diagnosis confirmed histologically o Stage 1-3 HNC pathologically confirmed diagnosis of squamous cell carcinoma of the oropharynx, larynx, hypopharynx, nasopharyngeal, or oral cavity * Plan to receive radiotherapy (\>60 Gy), chemo-irradiation or bio-radiation either as primary or as a post-operative treatment to the head and neck region * Eastern Cooperative Oncology Group Performance Status (ECOGPS) performance status 0 or 1 * Comply with the study protocol * Capable of signing a written informed consent Exclusion Criteria: * An allergy, intolerance, or contraindication to colchicine * Current treatment with colchicine for medical conditions, e.g. gout and Familial Mediterranean Fever (FMF) * Estimated glomerular filtration rate (GFR) \< 55 ml/min since colchicine should not be given * Severe liver disease or current aminotransferase levels of more than 1.5 times the upper limit of the normal range * Previous irradiation to the head and/or neck region * Distant metastatic disease or locally recurrent disease * Pre-existing skin rashes, ulcerations, or open wounds in the treatment area * Known allergic and other systemic skin diseases even when not directly affecting irradiated fields * Substance abuse, medical conditions, and/or social issues that would limit conduct or follow-up in the research study, in the opinion of the investigator * Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator * Using high doses of non-steroidal anti-inflammatory drugs * Pregnant and lactating women * Psychiatric illness that would prevent the patient from giving informed consent * Taking cetuximab or other radiosensitizing agents.

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Conditions

The condition(s) this trial relates to.

dermatitis head and neck squamous cell carcinoma radiodermatitis prevention target

As listed by the trial registrant

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

Radiation therapy

Contacts and locations

Locations

  • RWJBarnabas Health - Cooperman Barnabas

    Livingston, New Jersey, 07039, United States

  • Robert Wood Johnson University Hospital

    New Brunswick, New Jersey, 08901, United States

  • Rutgers, The State University of New Jersey Board Contact:

    New Brunswick, New Jersey, 08901, United States

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