Evaluation of the Effectiveness of the Radiofrequency Ablation for Reducing Refractory Pain From Bone Metastases
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Maximum Pain Level Decreased by ≥ 2 Points at 2 Months After Radiofrequency Ablation (RFA)
研究概览
简要总结
RATIONALE: Morphine may reduce pain in patients who have undergone radiofrequency ablation to remove bone metastases.
PURPOSE: This phase II trial is studying how well morphine works after radiofrequency ablation of painful bone metastases in patients with cancer.
详细描述
OBJECTIVES:
Primary
- Measure the efficacy of morphine sulfate at 8 weeks after radiofrequency ablation (RFA) of bone metastases.
Secondary
- Assess minimum and average pain and analyze use of morphine sulfate before and after RFA.
- Determine disease progression by CT scan of bone.
- Evaluate the percentage of relief associated with RFA, specifically patient satisfaction, quality of life, anxiety, depression, and physical performance during RFA.
- Assess complications and side effects related to RFA and the evolution of possible side effects associated with morphine sulfate 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
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Patient who has undergone radiofrequency ablation of bone metastases
Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
干预措施: Acetaminophen (Drug)
Patient who has undergone radiofrequency ablation of bone metastases
Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
干预措施: Morphine Sulfate (Drug)
Patient who has undergone radiofrequency ablation of bone metastases
Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
干预措施: Questionnaire administration (Other)
Patient who has undergone radiofrequency ablation of bone metastases
Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
干预措施: Quality-of-life assessment (Procedure)
Patient who has undergone radiofrequency ablation of bone metastases
Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
干预措施: Radiofrequency ablation (Procedure)
结局指标
主要结局
Percentage of Participants With Maximum Pain Level Decreased by ≥ 2 Points at 2 Months After Radiofrequency Ablation (RFA)
时间窗: 2 months after radiofrequency ablation (RFA)
Difference in maximum pain scores between inclusion and 2 months after radiofrequency ablation (RFA) according to an 11-point numerical scale Rate of patients with a decrease of two or more points in their most intense pain, 2 months after the radiofrequency ablation. This rate is calculated for the evaluable population for the principal outcome measure. This rate is equal to the ratio of the number of patients with a decrease of two or more points in their maximum pain divided by the size of the evaluable population. The response rate considered acceptable is 50%, above this threshold the treatment will be considered potentially effective and may be proposed in phase III.
次要结局
- Difference in Maximum Pain Scores Between Inclusion and 2 Months After Radiofrequency Ablation(Inclusion and 2 months after radiofrequency ablation (RFA))
- Intensity of Pain (Minimum, Average, Maximum)(Algology assessment 3 months after radiofrequency)
- Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day(3 months after radiofrequency)
- Total Intravenous Morphine Dose (mg)(24 hours after radiofrequency)
- Bolus Dose in mg Administered by Patient-controlled Analgesia (PCA)(24 hours after radiofrequency)
- Standardised Quality of Life Scores (EORTC - QLQ-C30)(2 months after radiofrequency)