Dexamethasone for the Prophylaxis of Radiation-Induced Pain Flare Following Palliative Radiotherapy for Bone Metastases
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Complete control of pain flare on days 1-5 after the completion of radiation treatment.
研究概览
简要总结
Radiation treatment is often recommended as a safe and quick treatment that gives most people good relief from bone pain within a couple of weeks. However, some people can experience a short episode of increased pain (called a 'flare') a day or two after radiation treatment, that lasts about a day. The purpose of this sturdy is to find out if a medication called dexamethasone can help prevent pain flare as a result of radiation therapy.
详细描述
Of all people diagnosed with cancer, 25% will have their cancer come back and spread to the bones. This often results in significant pain and suffering. Radiation treatment is often recommended as a safe and quick treatment that gives most people good relief from bone pain within a couple of weeks. However, some people can experience a short episode of increased pain called a flare a day or two after radiation treatment that lasts about a day. Studies suggest that around a third of all people who receive radiation treatment to help pain from cancer in the bones will have a pain flare. This study is being done because it would be helpful to prevent extra bone pain from happening to people after they receive radiation treatments. The purpose of this study is to find out if a medication called dexamethasone can help prevent pain flare as a result of radiation therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Documented bone metastases by radiological imaging
- •Patients at least 18 years of age
- •Written consent
- •Baseline worst pain at the planned radiated bony metastatic site ≥ 2
- •Patient able to inform the pain score at the planned radiated bony metastatic site
排除标准
- •Concurrent use of any corticosteroid medication other than topical or inhaled preparations
- •Medical contraindications to corticosteroids such as diabetes mellitus, uncontrolled hypertension or active peptic ulcer
- •Pathological fracture of the irradiated extremity
- •Spinal cord compression
- •Language barrier
- •Immediate change in regular analgesic medication. If the oncologist thinks the patient is not receiving adequate analgesic, we recommend the oncologist to increase the analgesic first to stabilize ot lessen the pain before recruiting the patient to this study
研究组 & 干预措施
Dexamethasone
8mg Dexamethasone PO on days 0 (prior to radiation treatment), and days 1, 2, and 3 following radiation treatment.
干预措施: dexamethasone (Drug)
结局指标
主要结局
Complete control of pain flare on days 1-5 after the completion of radiation treatment.
时间窗: Days 1-5
次要结局
- Complete control of pain flare from Day 6-10 after the completion of radiation treatment.(Days 6-10)
- Functional interference especially mood and sleep in Brief Pain Inventory will be monitored.(Days 0, 1-10, and 6-weeks from baseline assessment)
- Quality of life outcomes(Baseline and 6-weeks following treatment)
研究者
Dr. Edward Chow
Professor
Sunnybrook Health Sciences Centre