Clinical trial NCT05335148: Study to Evaluate the Safety of Colchicine
Official title: Evaluate the Safety of Colchicine for Treatment and Prevention of Radiation-Induced Dermatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Radiation Therapy
Keywords: Radiation therapy
Dermatitis
Low-dose colchicine
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Perform a phase I study for evaluating the safety of oral colchicine in preventing and treating radiation-induced dermatitis among head and neck cancer patients.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain - Visual Analogue Scale (VAS)
timeFrame: 10 weeks
Secondary outcomes:
measure: Erythema - Common Toxicity Criteria for Adverse Events (CTCAE)
timeFrame: 10 weeks
Other outcomes:
measure: Health-Related Quality-of-Life - Questionnaire
timeFrame: 10 weeks
measure: Health-Related Quality-of-Life - Quality of Life Questionnaire
timeFrame: 10 weeks
Locations:
city: Livingston
country: United States
facility: RWJBarnabas Health - Cooperman Barnabas
state: New Jersey
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers, The State University of New Jersey Board Contact:
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Bruce Haffty, MD
role: PRINCIPAL_INVESTIGATOR
References: