๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-05-18

Study to Evaluate the Safety of Colchicine (NCT05335148)

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

๐Ÿ”ต Active, Not Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Rutgers, The State University of New Jersey

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: RWJBarnabas Health - Cooperman Barnabas โ€” Livingston, New Jersey

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (3 Sites)

  • RWJBarnabas Health - Cooperman Barnabas โ€” Livingston, New Jersey
  • Robert Wood Johnson University Hospital โ€” New Brunswick, New Jersey
  • Rutgers, The State University of New Jersey Board Contact: โ€” New Brunswick, New Jersey

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—