Influences on the Nutrition Statuses and Clinical Outcomes of Early Use of Opioid to Control Local Mucosa Pain Induced by Irradiation in Nasopharyngeal Carcinoma Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Body Mass Index (BMI)
研究概览
简要总结
This study is a superiority research to evaluate the safety and effectiveness of early use of oxycodone control release tablet for radiation mucositis in nasopharyngeal carcinoma patients.
详细描述
The present study is a prospective, randomizing, case-controlled, multi-center clinical trial. 174 firstly diagnosed nasopharyngeal carcinoma patients who need radical radiation therapy will be randomly divided into either early intervention or common intervention group. oxycodone control release tablets will be used to control the pain caused by radiation oral mucositis when the pain level is mild or moderate, respectively. The primary outcome measurement is nutrition status. Quality of life (QOL), the clinical outcomes, and the adverse effects are also to be observed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Histological confirmed nasopharyngeal carcinoma;
- •Without historic chronic pain, no depend on analgesic drugs, no historic opioids intake;
- •Plan to receive radical radiation therapy, newly to radiation for head and neck;
- •Aged older or equal to 18 years old;
- •Could understand and cooperate to accomplish pain evaluation and observation scales;
- •Sufficient liver and kidney function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 2.5* upper limit of normal (ULN), serum creatinine less than 1.5*ULN;
- •Without other serious critical organ dysfunction, such as heart or lung dysfunction;
- •Performance status (PS) score less than 2;
- •Voluntary to participate and sign informed consent document;
- •Obey the rules of trail; could be followed-up on time.
排除标准
- •Excluded by inclusion criteria;
- •Known or suspected allergy to nonsteroidal anti-inflammatory drug (NSAID) or opioid medicine;
- •Unable to complete the follow-up;
- •Severe uncontrollable infections of medical disorders;
- •Major organ including heart, lung, kidney, or liver dysfunction;
- •With pathophysiological factors affecting drug absorption, distribution, metabolism or excretion.
研究组 & 干预措施
Mild group
Use oxycodone when pain is mild level. Start from 10 mg every 12 hours and titrate for appropriate dose.
干预措施: Oxycodone (Drug)
Moderate group
Use oxycodone when pain is moderate or severe level. Start from 10 mg every 12 hours and titrate for appropriate dose.
干预措施: Oxycodone (Drug)
结局指标
主要结局
Body Mass Index (BMI)
时间窗: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
Body mass index (BMI, kg/m2) was defined as the body mass (kg) divided by the square of the body height (m).
次要结局
- Numeric rating scale (NRS)(Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.)
- Hemoglobin(Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.)
- Albumin(Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.)
- Quality of life score(Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.)
- Dizziness(Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.)
- Nausea/vomiting(Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.)
- Somnolence(Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.)