Phase 2
Completed N=78
Morphine After Radiofrequency Ablation of Painful Bone Metastases in Patients With Cancer
Metastatic cancer · Postoperative Pain · Unspecified Adult Solid Tumor, Protocol Specific
Source: ClinicalTrials.gov NCT00712712 ↗
Enrolled (actual)
78
Serious AEs
46.5%
Results posted
Mar 2021
Primary outcomePrimary: Percentage of Participants With Maximum Pain Level Decreased by ≥ 2 Points at 2 Months After Radiofrequency Ablation (RFA) — 83.6 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Maximum Pain Level Decreased by ≥ 2 Points at 2 Months After Radiofrequency Ablation (RFA) |
83.6 | — |
| SECONDARY Difference in Maximum Pain Scores Between Inclusion and 2 Months After Radiofrequency Ablation |
4; 2; 49 | — |
| SECONDARY Intensity of Pain (Minimum, Average, Maximum) |
0.0; 1.0; 2.5 | — |
| SECONDARY Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day |
50.0 | — |
| SECONDARY Total Intravenous Morphine Dose (mg) |
3.0 | — |
| SECONDARY Bolus Dose in mg Administered by Patient-controlled Analgesia (PCA) |
1.0 | — |
| SECONDARY Standardised Quality of Life Scores (EORTC - QLQ-C30) |
60.0; 50.0; 62.5; 50.0; 50.0; 50.0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00712712). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.