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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00712712
First received: July 9, 2008
Last updated: December 13, 2009
Last verified: July 2009
  Purpose

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 Intervention 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

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum pain level decreased by ≥ 2 points at 8 weeks after radiofrequency ablation (RFA) [ Designated as safety issue: No ]

Estimated Enrollment: 63
Study Start Date: October 2007
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712712

Locations
France
Institut Bergonie Recruiting
Bordeaux, France, 33076
Contact: Contact Person    33-556-333-333    dixmerias@bergonie.org   
Sponsors and Collaborators
Institut Bergonié
Investigators
Study Chair: Florence Dixmerias, MD Institut Bergonié
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00712712     History of Changes
Other Study ID Numbers: CDR0000589594, IB-MEDOR, IB-2007-16, INCA-RECF0498, EUDRACT-2007-002686-13
Study First Received: July 9, 2008
Last Updated: December 13, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
bone metastases
unspecified adult solid tumor, protocol specific
pain

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Acetaminophen
Morphine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on August 28, 2014