Morphine After Radiofrequency Ablation of Painful Bone Metastases in Patients With Cancer
Recruitment status was: Recruiting
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.
Unspecified Adult Solid Tumor, Protocol Specific
Drug: morphine sulfate
Other: questionnaire administration
Procedure: quality-of-life assessment
Procedure: radiofrequency ablation
|Study Design:||Allocation: Non-Randomized
Primary Purpose: Supportive Care
|Official Title:||Evaluation of the Effectiveness of the Radiofrequency Ablation for Reducing Refractory Pain From Bone Metastases|
- Maximum pain level decreased by ≥ 2 points at 8 weeks after radiofrequency ablation (RFA) [ Designated as safety issue: No ]
|Study Start Date:||October 2007|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
- Measure the efficacy of morphine sulfate at 8 weeks after radiofrequency ablation (RFA) of bone metastases.
- 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.
OUTLINE: This is a multicenter study.
Patients complete a pain questionnaire over 1 week before undergoing radiofrequency ablation (RFA). Patients also complete questionnaires about pain, physical performance, quality of life (QOL), and anxiety at baseline.
Bone metastases are removed by radiofrequency ablation (RFA). After surgery, patients receive acetaminophen and patient-controlled analgesic (PCA) morphine sulfate. PCA morphine sulfate continues with a dose increase of 50% bolus every 24 hours. Patients with maximum pain less than or equal to that at inclusion receive standard morphine sulfate therapy instead.
Data concerning the total dose of PCA morphine sulfate; minimum, average, and maximum pain intensity; side effects and complications of RFA; and total dose of morphine sulfate (or equivalent) is collected daily.
Pain is assessed at 4 and 8 weeks after RFA. Patients complete follow-up questionnaires about physical performance, QOL, and anxiety at 12 weeks. Patients also undergo a CT scan at 12 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00712712
|Bordeaux, France, 33076|
|Study Chair:||Florence Dixmerias, MD||Institut Bergonié|