A Phase l Study to Evaluate the Safety of Colchicine

• Status: Not yet recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rutgers, The State University of New Jersey
• Treatments: Colchicine

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.