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Morphine After Radiofrequency Ablation of Painful Bone Metastases in Patients With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00712712
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : July 10, 2008
Last Update Posted : December 15, 2009
Information provided by:
National Cancer Institute (NCI)

Brief 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.

Condition or disease Intervention/treatment Phase
Metastatic Cancer Pain Unspecified Adult Solid Tumor, Protocol Specific Drug: acetaminophen Drug: morphine sulfate Other: questionnaire administration Procedure: quality-of-life assessment Procedure: radiofrequency ablation Phase 2

Detailed Description:



  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Allocation: Non-Randomized
Primary Purpose: Supportive Care
Official Title: Evaluation of the Effectiveness of the Radiofrequency Ablation for Reducing Refractory Pain From Bone Metastases
Study Start Date : October 2007
Estimated Primary Completion Date : December 2010

Primary Outcome Measures :
  1. Maximum pain level decreased by ≥ 2 points at 8 weeks after radiofrequency ablation (RFA)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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)


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00712712

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Institut Bergonie Recruiting
Bordeaux, France, 33076
Contact: Contact Person    33-556-333-333   
Sponsors and Collaborators
Institut Bergonié
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Study Chair: Florence Dixmerias, MD Institut Bergonié

Layout table for additonal information Identifier: NCT00712712    
Other Study ID Numbers: CDR0000589594
First Posted: July 10, 2008    Key Record Dates
Last Update Posted: December 15, 2009
Last Verified: July 2009
Keywords provided by National Cancer Institute (NCI):
bone metastases
unspecified adult solid tumor, protocol specific
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic