A Phase I Study to Evaluate the Safety of Colchicine for Treatment and Prevention of Radiation-Induced Dermatitis.

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.