Clinical trial NCT00712712: Morphine After Radiofrequency Ablation of Painful Bone Metastases in Patients With Cancer
Official title: Evaluation of the Effectiveness of the Radiofrequency Ablation for Reducing Refractory Pain From Bone Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Cancer
Pain
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: bone metastases
unspecified adult solid tumor, protocol specific
pain
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
First posted: 2008-07-10
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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 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

Primary outcomes:
measure: 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)
Secondary outcomes:
measure: Difference in Maximum Pain Scores Between Inclusion and 2 Months After Radiofrequency Ablation
timeFrame: Inclusion and 2 months after radiofrequency ablation (RFA)
measure: Intensity of Pain (Minimum, Average, Maximum)
timeFrame: First algology assessment at pre-selection visit
measure: Intensity of Pain (Minimum, Average, Maximum)
timeFrame: Second algology assessment at inclusion visit
measure: Intensity of Pain (Minimum, Average, Maximum)
timeFrame: Algology assessment one day before radiofrequency (J-1)
measure: Intensity of Pain (Minimum, Average, Maximum)
timeFrame: Algology assessment one day after radiofrequency: J+1
measure: Intensity of Pain (Minimum, Average, Maximum)
timeFrame: Algology assessment at the discharge from hospital visit
measure: Intensity of Pain (Minimum, Average, Maximum)
timeFrame: Algology assessment 7 days after discharge from hospital
measure: Intensity of Pain (Minimum, Average, Maximum)
timeFrame: Algology assessment 1 month after radiofrequency
measure: Intensity of Pain (Minimum, Average, Maximum)
timeFrame: Algology assessment 2 months after radiofrequency
measure: Intensity of Pain (Minimum, Average, Maximum)
timeFrame: Algology assessment 3 months after radiofrequency
measure: Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
timeFrame: Preselection: First algology visit (within a week (± 3 days) after the radiology consultation)
measure: Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
timeFrame: Inclusion: Second algology visit (One week after the first algology visit)
measure: Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
timeFrame: J-1 (One day before radiofrequency)
measure: Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
timeFrame: Discharge from hospital
measure: Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
timeFrame: 7 days after discharge
measure: Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
timeFrame: 1 month after radiofrequency
measure: Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
timeFrame: 2 months after radiofrequency
measure: Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
timeFrame: 3 months after radiofrequency
measure: Total Intravenous Morphine Dose (mg)
timeFrame: 24 hours after radiofrequency
measure: Bolus Dose in mg Administered by Patient-controlled Analgesia (PCA)
timeFrame: 24 hours after radiofrequency
measure: Standardised Quality of Life Scores (EORTC - QLQ-C30)
timeFrame: Inclusion
measure: Standardised Quality of Life Scores (EORTC - QLQ-C30)
timeFrame: 2 months after radiofrequency
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institute Bergonié
Study officials:
affiliation: Institut Bergonié
name: Florence Dixmerias, MD
role: STUDY_CHAIR
References: