Study to Evaluate the Safety of Colchicine

A phase I study for evaluating the safety of oral colchicine in preventing and treating radiation-induced dermatitis among head and neck cancer patients who will receive RT for HNC. Prior to receiving RT, each subject will be receiving either the standard of care or low-dose oral colchicine (No randomization). There will be a comparison of the proportion of radiation-induced dermatitis in the two study arms. The individuals in the standard of care arm will receive a placebo colchicine pill once a day. Those who are in the experimental arm will receive 0.6 mg of oral colchicine once a day. The primary endpoint is the safety and tolerability of oral colchicine. The proportions of grade 2-4 radiation-induced dermatitis at the end of Radiation therapy (RT) and at the first follow-up three-four weeks post-treatment in these two study arms are the secondary study endpoints. In addition, pain, erythema, and health-related quality-of-life will be evaluated.

The study subjects will receive radiation therapy (RT) as scheduled and will meet with their clinicians for their follow-up visits.

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.