Study to Evaluate the Safety of Colchicine

Rutgers The State University of New Jersey

Status and phase

Enrolling

Phase 1

Conditions

Radiation Therapy

Treatments

Drug: oral colchicine(0.6 mg) once a day

Study type

Interventional

Funder types

Other

Identifiers

NCT05335148

032112

Pro2022000357 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.