study to evaluate the safety of colchicine

Conditions: Radiation Therapy

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.

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.

Eligibility criteria:
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.

Keywords: radiation therapy dermatitis low-dose colchicine