Study to Evaluate the Safety of Colchicine

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.

Conditions

Radiation Therapy

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Study Overview

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Study Details

Study overview

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.

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

Study to Evaluate the Safety of Colchicine

Condition
Radiation Therapy
Intervention / Treatment

-

Contacts and Locations

Livingston

RWJBarnabas Health - Cooperman Barnabas, Livingston, New Jersey, United States, 07039

New Brunswick

Robert Wood Johnson University Hospital, New Brunswick, New Jersey, United States, 08901

New Brunswick

Rutgers, The State University of New Jersey Board Contact:, New Brunswick, New Jersey, United States, 08901

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Eight years or older with HNC diagnosis confirmed histologically
  • * 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
  • * 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

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Rutgers, The State University of New Jersey,

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

Study Record Dates

2024-06-01