Topical and Oral Melatonin for Preventing Concurrent Radiochemotherapy Induced Oral Mucositis and Xerostomia in Head and Neck Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Percentage of occurrence of mucositis level 3 or more by using the criteria of CTCAE version 4.0, World Health Organization scale and MTSscores
研究概览
简要总结
The study evaluates the effect of melatonin for preventing concurrent radiochemotherapy induced oral mucositis and xerostomia and improving quality of life in head and neck cancer patients. This is a randomized, double-blind, placebo controlled trial conducted in head and neck cancer patients. Mixed-block randomization is used to divide eligible patients into two groups: melatonin 40 mg or matched placebo. The patients are required to take the studied drugs 20 mg suspensions before radiation and 20 mg capsules at night (after 21.00 pm) on the first night of radiation and continue for 7 weeks. Standard treatment is Radiation 2 Gy 5 fraction/week not more than 7 weeks with Cisplatin chemotherapy base regimen according to standard hospital protocol. Study endpoints are level of mucositis (CTCAE scale, WHO scale and MTS scores), level of xerostomia (CTCAE scale, VAS), QOL (FACT-H&N), pain (VAS 0-10) and adverse event frequency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New diagnostic of head and neck cancer patient who need treatment with radiation involved with the oral cavity area.
- •Never received radiotherapy or chemotherapy
- •Karnofsky performance status > 70%
- •Stopped smoking
- •Able to eat and swallow medications
- •Written informed consent
排除标准
- •Melatonin allergy
- •Active oral cavity inflammation scar
- •Pregnancy
- •Creatinine clearance < 30 ml/min
- •Active periodontal disease
- •Steroids or pain killer drugs used for oral cavity pain except NSAIDs for thromboembolism prevention
- •Currently use benzydamine mouthwash
研究组 & 干预措施
Matched placebo
Drug: match placebo Drug: placebo suspension gargle for 2 minutes before radiation 15 minutes and placebo gelatin capsule taken orally after 21:00 hours each night throughout the study
干预措施: Matched Placebo (Drug)
Melatonin
Drug: Melatonin 20 mg/ 10 ml melatonin suspension gargle for 2 minutes before radiation 15 minutes and 20 mg melatonin gelatin capsule taken orally after 21:00 hours each night throughout the study
干预措施: Melatonin (Drug)
结局指标
主要结局
Percentage of occurrence of mucositis level 3 or more by using the criteria of CTCAE version 4.0, World Health Organization scale and MTSscores
时间窗: Time to event (occurence of mucositis level 3) during 7 weeks of treatment
Participants will be followed for severity of mucositis during the treatment period of 7 weeks
次要结局
- Percentage of occurrence of xerostomia level 2 or more by using the criteria of CTCAE version 4.0 and the Visual Analogue Scale(Time to event (occurence of mucositis level 3) during 7 weeks of treatment)
- Quality of Life (FACT- H&N Version 4)(Change from baseline in Trial Outcome Index scores at 7th week)
研究者
Nutjaree Pratheepawanit Johns
Khon Kaen University
Khon Kaen University