Study to Evaluate the Safety of Colchicine
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.
Conditions:
🦠 Radiation Therapy
🗓️ Study Start (Actual) 10 May 2022
🗓️ Primary Completion (Estimated) 1 June 2024
✅ Study Completion (Estimated) 1 June 2024
👥 Enrollment (Estimated) 30
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Livingston, New Jersey, United States
📍 New Brunswick, New Jersey, United States
📍 New Brunswick, New Jersey, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Eight years or older with HNC diagnosis confirmed histologically
    • o Stage 1-3 HNC pathologically confirmed diagnosis of squamous cell carcinoma of the oropharynx, larynx, hypopharynx, nasopharyngeal, or oral cavity
    • * 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
    • * Eastern Cooperative Oncology Group Performance Status (ECOGPS) performance status 0 or 1
    • * Comply with the study protocol
    • * Capable of signing a written informed consent

    Exclusion Criteria:

    • * An allergy, intolerance, or contraindication to colchicine
    • * Current treatment with colchicine for medical conditions, e.g. gout and Familial Mediterranean Fever (FMF)
    • * Estimated glomerular filtration rate (GFR) \< 55 ml/min since colchicine should not be given
    • * Severe liver disease or current aminotransferase levels of more than 1.5 times the upper limit of the normal range
    • * Previous irradiation to the head and/or neck region
    • * Distant metastatic disease or locally recurrent disease
    • * Pre-existing skin rashes, ulcerations, or open wounds in the treatment area
    • * Known allergic and other systemic skin diseases even when not directly affecting irradiated fields
    • * 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
    • * Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator
    • * Using high doses of non-steroidal anti-inflammatory drugs
    • * Pregnant and lactating women
    • * Psychiatric illness that would prevent the patient from giving informed consent
    • * Taking cetuximab or other radiosensitizing agents.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 13 April 2022
  • First Submitted that Met QC Criteria 13 April 2022
  • First Posted 19 April 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 8 November 2023
  • Last Update Posted 9 November 2023
  • Last Verified November 2023