Active — Not RecruitingPhase 1

Study to Evaluate the Safety of Colchicine

United States30 participantsStarted 2022-05-10

Plain-language summary

Currently, there are no approved medications for the prevention and treatment of radiation-induced dermatitis, or skin discoloration/burning due to radiation therapy, because there is little evidence to guide treatment. The purpose of the research is to better understand the factors associated with radiation-induced dermatitis and to explore the efficacy of low-dose colchicine in reducing the proportion of patients with radiation-induced dermatitis who undergo radiation treatment for head and neck cancer. If you take part in the research, you will be asked to take 0.6 mg once a day by mouth. The participants time in the study will take less than a minute a day to take the pill and 20 minutes to complete survey questions during follow-up visits.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 th…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain - Visual Analogue Scale (VAS)

Timeframe: 10 weeks

Trial details

NCT IDNCT05335148

SponsorRutgers, The State University of New Jersey

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06

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