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ACTIVE NOT RECRUITING
NCT05335148
PHASE1

Study to Evaluate the Safety of Colchicine

Sponsor: Rutgers, The State University of New Jersey

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2022-05-10

Completion Date

2027-06-01

Last Updated

2026-05-20

Healthy Volunteers

No

Interventions

DRUG

oral colchicine(0.6 mg) once a day

The standard of care arm will receive a placebo colchicine pill once a day

Locations (3)

RWJBarnabas Health - Cooperman Barnabas

Livingston, New Jersey, United States

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Rutgers, The State University of New Jersey Board Contact:

New Brunswick, New Jersey, United States