Corticosteroids for Cancer Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- pain intensity at Day 7
研究概览
简要总结
Study hypothesis: corticosteroids are effective for pain in cancer patients. We will perform a double-blind, randomized, placebo-controlled multicentre trial evaluating the effect of Methylprednisolone 16 mg twice daily in cancer patients with pain (average pain last 24 hrs NRS > 4 (Numerical rating scale, 0 No pain, 10 worst pain).
详细描述
Patients are required to use strong opioids before entering the study. Weak opioids are allowed if patients have short acting strong opioids as rescue-medication. The scheduled opioids shall be stable last 48 hours before entering the study and will be kept stable during the study period. Patients may use as much short acting rescue-medication as they require. No other analgesic medication should be started during the study period.
The study is a multicentre trial. Patients will be randomized according to 1. study centre (No 1-5) and 2. pain mechanism: skeletal metastases (yes/no).
Patients are evaluated Day 0 and Day 7 by palliative care physician. Patients will be contacted by phone Day 1-6 and will fill in questionnaire regarding symptoms and analgesic usage. Patients will be contacted Day 14 and 21 to fill in questionnaires regarding symptoms, quality of life and side effects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Verified malignant disease
- •Receiving a scheduled strong or weak opioid
- •Insufficient pain control: Average pain last 24 h: ≥ 4 (NRS 0-10)
- •Given informed consent according to the ethical guidelines
- •Able to complete planned assessment schedules
- •≥ 18 years of age
- •Life expectancy > 1 month
排除标准
- •Excruciating pain (average pain ≥ 8) (These patients should be considered as emergency patients. Patients may be eligible for the study after stabilization)
- •Dose adjustment in scheduled opioid medication last 48 hours
- •Concurrent medication with NSAIDs (Patients are eligible for the study one week after NSAIDs are discontinued)
- •Receiving radiotherapy within 4 weeks before entering the study or planned within the study period
- •Started systemic treatment (chemotherapy, hormone therapy or bisphosphonates) within 4 weeks before entering the study Patients who have received chemotherapy for more than 4 weeks are eligible for the study if it is more than 7 days since receiving the last dose and they are not having the next dose within the study period
- •Manifest spinal cord compression or in need of bone surgery
- •Severe cognitive impairment
- •Previously on steroids during the last 4 weeks
- •Diabetes mellitus
- •Known peptic ulcer disease
- •Systemic fungal disease, patients vaccinated with viable viruses, and patients with known allergies to the study medication (MethylPrednisolone)
- •Female patients who are pregnant or lactating.
- •Women of reproductive potential not willing or unable to employ an effective method of contraception (be sterilized, using IUD or oral contraception)
- •Patients using following medication: cyclosporin, erythromycin, phenobarbital, phenytoin, carbamazepin, ketoconazole, methotrexate, ciclofosfamide, rifampicin, aprepitant and diltiazem.
研究组 & 干预措施
Methylprednisolone
Methylprednisolone 16 mg twice daily
干预措施: Methylprednisolone (Drug)
Placebo
Placebo capsules twice daily
干预措施: Placebo (Drug)
结局指标
主要结局
pain intensity at Day 7
时间窗: 7 days
change of pain intensity at Day 7, measured by "average pain for the last 24 hours" (NRS 0-10).
次要结局
- appetite(7 days)
- fatigue(7 days)
- Overall effect satisfaction(7 days)
- sleep quality(7 days)
- analgesic usage(7 days)
- Pain now and average pain last 24 hrs(7 days)