Colchicine for Treatment and Prevention of Radiation-Induced Dermatitis

Inclusion Criteria

• 18 years or older with head and neck cancer (HNC) diagnosis confirmed histologically. * Stage 1-4 HNC pathologically confirmed diagnosis of squamous cell carcinoma of the oropharynx, larynx, hypopharynx, nasopharyngeal, or oral cavity.
• Those who 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.
• The Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Those who can comply with the study protocol.
• Those who is capable of signing a written informed consent.

Exclusion Criteria

• Those with 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.
• Patients with pre-existing skin rashes, ulcerations, or open wounds in the treatment area.
• Patients with known allergic and other systemic skin diseases even when not directly affecting irradiated fields.
• Patients with 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.
• Patients using high doses of non-steroidal anti-inflammatory drugs.
• Pregnant and lactating women.
• Psychiatric illness that would prevent the patient from giving informed consent.
• Patients who taking cetuximab or other radiosensitizing agents.