Study to Evaluate the Safety of Colchicine

Launched by RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY · Apr 13, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating the safety and effectiveness of a medication called colchicine for patients receiving radiation therapy for head and neck cancer. Radiation therapy can cause a skin condition known as radiation-induced dermatitis, which leads to skin discoloration and burning. Currently, there are no approved treatments for this condition, so researchers are exploring whether low doses of colchicine can help reduce the number of patients who experience this skin problem during their treatment.

To participate in this study, you need to be at least 8 years old and have a confirmed diagnosis of certain types of head and neck cancer. You should be planning to receive radiation treatment as part of your care. If you join the study, you will take a small pill (0.6 mg of colchicine) once a day and will spend about 20 minutes answering survey questions during follow-up visits. Your total time commitment for the study will be minimal, and your safety will be closely monitored. Please note that there are specific health conditions that may prevent you from participating, so it's important to discuss your eligibility with your healthcare provider.

Gender

ALL

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.