drugset / Trial / NCT05335148

Study to Evaluate the Safety of Colchicine

NCT05335148

Phase 1 Active not recruiting 30 enrolled Rutgers, The State University of New Jersey
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2022-05-10
Primary completion
2026-06
Completion
2027-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Colchicine Small molecule 0.6 mg Oral

Indications

No indication recorded.