Morphine After Radiofrequency Ablation of Painful Bone Metastases in Patients With Cancer (NCT00712712) | Clinical Trial Compass
CompletedPhase 2
Morphine After Radiofrequency Ablation of Painful Bone Metastases in Patients With Cancer
France78 participantsStarted 2007-12-24
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed cancer
* Primary or unknown origin
* Painful bone metastases despite radiotherapy or symptomatic relapse into previously irradiated area with no possibility of repeating radiotherapy
* Bone metastases may have been treated with bisphosphonates
* Osteolytic bone or joint (lytic and condensed) confirmed by CT scan and meeting the following criteria:
* Lesion size ≤ 5 cm
* No more than 2 painful bone metastases
* If 2 lesions are to be treated, distinct anatomical locations can be treated at the same time
* Metastatic bone lesions of the pelvis, sacrum (in absence of canal involvement), ribs, or long bones allowed
* Pain located at the tumor or in the area
* Maximum pain in the last 24 hours \> 4 points (numerical scale to 11 points)
PATIENT CHARACTERISTICS:
* Life expectancy \> 3 months
* Platelet count \> 50,000/μL
* Prothrombin \< 50%
* Activated cephalin time ≤ 1.5 times normal
* Not pregnant
* Fertile patients must use effective contraception
* No geographical, social, or psychiatric reason that would preclude follow up
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy
* At least 3 weeks since prior chemotherapy or bisphosphonates
* At least 1 week since beginning new painkiller therapy or anticoagulation treatment
* More than 30 days since participation in another drug study
* More than 30 days since prior surgery
What they're measuring
1
Percentage of Participants With Maximum Pain Level Decreased by ≥ 2 Points at 2 Months After Radiofrequency Ablation (RFA)
Timeframe: 2 months after radiofrequency ablation (RFA)