NCT05335148

Study to Evaluate the Safety of Colchicine

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Radiation Therapy

Interventions

Type	Name	Description
DRUG	oral colchicine(0.6 mg) once a day	The standard of care arm will receive a placebo colchicine pill once a day

Timeline

• Start date: 2022-05-10
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2022-04-19
• Last updated: 2023-11-09

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study