oral colchicine(0.6 mg) once a day for Dermatitis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Robert Wood Johnson University Hospital, New Brunswick, NJ
Dermatitis+1 More
oral colchicine(0.6 mg) once a day - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Dermatitis
  • Radiation Therapy

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Dermatitis

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 10 weeks

10 weeks
Erythema - Common Toxicity Criteria for Adverse Events (CTCAE)
Health-Related Quality-of-Life - Quality of Life Questionnaire
Health-Related Quality-of-Life - Questionnaire
Pain - Visual Analogue Scale (VAS)

Trial Safety

Safety Progress

1 of 3

Other trials for Dermatitis

Trial Design

2 Treatment Groups

Standard of care arm - placebo colchicine pill
1 of 2
Experimental arm - oral colchicine once a day
1 of 2
Active Control
Experimental Treatment

30 Total Participants · 2 Treatment Groups

Primary Treatment: oral colchicine(0.6 mg) once a day · No Placebo Group · Phase 1

Experimental arm - oral colchicine once a day
Drug
Experimental Group · 1 Intervention: oral colchicine(0.6 mg) once a day · Intervention Types: Drug
Standard of care arm - placebo colchicine pillNoIntervention Group · 1 Intervention: Standard of care arm - placebo colchicine pill · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 10 weeks
Closest Location: Robert Wood Johnson University Hospital · New Brunswick, NJ
Photo of new jersey 1Photo of new jersey 2Photo of new jersey 3
2004First Recorded Clinical Trial
1 TrialsResearching Dermatitis
43 CompletedClinical Trials

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
361 Previous Clinical Trials
60,157 Total Patients Enrolled
1 Trials studying Dermatitis
1 Patients Enrolled for Dermatitis
Bruce Haffty, MDPrincipal InvestigatorRutgers Cancer Institute of New Jersey
3 Previous Clinical Trials
469 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have been diagnosed with HNC for at least 8 years.
You have a performance status of 0 or 1.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.