Study to Evaluate the Safety of Colchicine

Last updated: November 8, 2023
Sponsor: Rutgers, The State University of New Jersey
Overall Status: Active - Recruiting

Phase

1

Condition

Cancer Treatment

Treatment

oral colchicine(0.6 mg) once a day

Clinical Study ID

NCT05335148
032112
Pro2022000357
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Eight years or older with HNC diagnosis confirmed histologically o Stage 1-3 HNC pathologically confirmed diagnosis of squamous cell carcinoma of theoropharynx, larynx, hypopharynx, nasopharyngeal, or oral cavity
  • Plan to receive radiotherapy (>60 Gy), chemo-irradiation or bio-radiation either asprimary 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

Exclusion Criteria:

  • An allergy, intolerance, or contraindication to colchicine
  • Current treatment with colchicine for medical conditions, e.g. gout and FamilialMediterranean Fever (FMF)
  • Estimated glomerular filtration rate (GFR) < 55 ml/min since colchicine should not begiven
  • Severe liver disease or current aminotransferase levels of more than 1.5 times theupper 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 affectingirradiated fields
  • Substance abuse, medical conditions, and/or social issues that would limit conduct orfollow-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 theircompliance 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.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: oral colchicine(0.6 mg) once a day
Phase: 1
Study Start date:
May 10, 2022
Estimated Completion Date:
June 01, 2024

Study Description

A phase I study for evaluating the safety of oral colchicine in preventing and treating radiation-induced dermatitis among head and neck cancer patients who will receive RT for HNC. Prior to receiving RT, each subject will be receiving either the standard of care or low-dose oral colchicine (No randomization). There will be a comparison of the proportion of radiation-induced dermatitis in the two study arms. The individuals in the standard of care arm will receive a placebo colchicine pill once a day. Those who are in the experimental arm will receive 0.6 mg of oral colchicine once a day. The primary endpoint is the safety and tolerability of oral colchicine. The proportions of grade 2-4 radiation-induced dermatitis at the end of Radiation therapy (RT) and at the first follow-up three-four weeks post-treatment in these two study arms are the secondary study endpoints. In addition, pain, erythema, and health-related quality-of-life will be evaluated.

The study subjects will receive radiation therapy (RT) as scheduled and will meet with their clinicians for their follow-up visits.

Connect with a study center

  • RWJBarnabas Health - Cooperman Barnabas

    Livingston, New Jersey 07039
    United States

    Active - Recruiting

  • Robert Wood Johnson University Hospital

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • Rutgers, The State University of New Jersey Board Contact:

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

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