Evaluate the Safety of Colchicine for Treatment and Prevention of Radiation-Induced Dermatitis
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Pain - Visual Analogue Scale (VAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Experimental arm - oral colchicine once a day
The experimental arm will receive 0.6 mg of oral colchicine once a day
干预措施: oral colchicine(0.6 mg) once a day (Drug)
Standard of care arm - placebo colchicine pill
The standard of care arm will receive a placebo colchicine pill once a day
结局指标
主要结局
Pain - Visual Analogue Scale (VAS)
时间窗: 10 weeks
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)
次要结局
- Erythema - Common Toxicity Criteria for Adverse Events (CTCAE)(10 weeks)
研究者
Bruce G Haffty
Associate Vice Chancellor Cancer Programs Professor and Chairman Department of Radiation Oncology
Rutgers, The State University of New Jersey