Study to Evaluate the Safety of Colchicine

Radiation Therapy Clinical Trial

Official title: Evaluate the Safety of Colchicine for Treatment and Prevention of Radiation-Induced Dermatitis

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Radiation Therapy

• NCT number: NCT05335148
• Study type: Interventional
• Source: Rutgers, The State University of New Jersey
• Contact: Bruce Haffty, MD
• Phone: 732-235-5203
• Email: hafftybg@cinj.rutgers.edu
• Status: Recruiting
• Phase: Phase 1
• Start date: May 10, 2022
• Completion date: June 1, 2024