Study to Evaluate the Safety of Colchicine

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Radiation Therapy

Intervention / Treatment
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* Drug: oral colchicine(0.6 mg) once a day


Participation Criteria
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Eligibility Criteria
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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
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of care arm - placebo colchicine pill<br>The standard of care arm will receive a placebo colchicine pill once a day | |
| Experimental: Experimental arm - oral colchicine once a day<br>The experimental arm will receive 0.6 mg of oral colchicine once a day | Drug: oral colchicine(0.6 mg) once a day<br>* The standard of care arm will receive a placebo colchicine pill once a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain - Visual Analogue Scale (VAS) | Pain (within radiation fields): assessed before radiotherapy, weekly during radiotherapy, and at the end of treatment with the visual analogue scale (VAS) (from 0 = no pain to 100 = maximum pain) | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erythema - Common Toxicity Criteria for Adverse Events (CTCAE) | The National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) scale defines acute skin reactions to radiation occurring within the 90 days after therapy. Grade 1: faint erythema or dry desquamation. Arising within the first two to four weeks of treatment, these reactions cause skin redness, warmth, and a rash-like appearance. The patient may complain that their skin feels tight or sensitive. Grade 2: moderate to brisk erythema; patchy, moist desquamation usually confined to skin folds or creases. Moderate edema, dryness, pruritus, and flaking of skin layers (dry desquamation) also may occur. Grade 3: moist desquamation in areas other than creases and skinfolds. Bleeding may arise from minor trauma, such as abrasion. Grade 4: life-threatening consequences, such as full-thickness skin ulcers, necrosis, and spontaneous bleeding. Grade 5: death. | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low-dose colchicine, Radiation therapy, Dermatitis