RECRUITING

Study to Evaluate the Safety of Colchicine

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2022-05-10
Study Completion:2024-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05335148

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Eight years or older with HNC diagnosis confirmed histologically
  2. * Plan to receive radiotherapy (\>60 Gy), chemo-irradiation or bio-radiation either as primary or as a post-operative treatment to the head and neck region
  3. * Eastern Cooperative Oncology Group Performance Status (ECOGPS) performance status 0 or 1
  4. * Comply with the study protocol
  5. * Capable of signing a written informed consent
  1. * An allergy, intolerance, or contraindication to colchicine
  2. * Current treatment with colchicine for medical conditions, e.g. gout and Familial Mediterranean Fever (FMF)
  3. * Estimated glomerular filtration rate (GFR) \< 55 ml/min since colchicine should not be given
  4. * Severe liver disease or current aminotransferase levels of more than 1.5 times the upper limit of the normal range
  5. * Previous irradiation to the head and/or neck region
  6. * Distant metastatic disease or locally recurrent disease
  7. * Pre-existing skin rashes, ulcerations, or open wounds in the treatment area
  8. * Known allergic and other systemic skin diseases even when not directly affecting irradiated fields
  9. * Substance abuse, medical conditions, and/or social issues that would limit conduct or follow-up in the research study, in the opinion of the investigator
  10. * Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator
  11. * Using high doses of non-steroidal anti-inflammatory drugs
  12. * Pregnant and lactating women
  13. * Psychiatric illness that would prevent the patient from giving informed consent
  14. * Taking cetuximab or other radiosensitizing agents.

Contacts and Locations

Study Contact

Bruce Haffty, MD
CONTACT
732-235-5203
hafftybg@cinj.rutgers.edu
Naomi Schlesinger
CONTACT
732-235-7217
schlesna@rwjms.rutgers.edu

Principal Investigator

Bruce Haffty, MD
PRINCIPAL_INVESTIGATOR
Rutgers Cancer Institute of New Jersey

Study Locations (Sites)

RWJBarnabas Health - Cooperman Barnabas
Livingston, New Jersey, 07039
United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
United States
Rutgers, The State University of New Jersey Board Contact:
New Brunswick, New Jersey, 08901
United States

Collaborators and Investigators

Sponsor: Rutgers, The State University of New Jersey

  • Bruce Haffty, MD, PRINCIPAL_INVESTIGATOR, Rutgers Cancer Institute of New Jersey

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-10
Study Completion Date2024-06-01

Study Record Updates

Study Start Date2022-05-10
Study Completion Date2024-06-01

Terms related to this study

Keywords Provided by Researchers

  • Radiation therapy
  • Dermatitis
  • Low-dose colchicine

Additional Relevant MeSH Terms

  • Radiation Therapy