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

Phase 2

Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Metastatic Cancer
Pain

Interventions: Drug: Acetaminophen
Drug: Morphine Sulfate
Other: Questionnaire administration
Procedure: Quality-of-life assessment
Procedure: Radiofrequency ablation

Registration Number: NCT00712712

Lead Sponsor: Institut Bergonié

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 78

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient who has undergone radiofrequency ablation of bone metastases	Questionnaire administration	Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
Patient who has undergone radiofrequency ablation of bone metastases	Quality-of-life assessment	Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
Patient who has undergone radiofrequency ablation of bone metastases	Radiofrequency ablation	Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
Patient who has undergone radiofrequency ablation of bone metastases	Acetaminophen	Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
Patient who has undergone radiofrequency ablation of bone metastases	Morphine Sulfate	Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Maximum Pain Level Decreased by ≥ 2 Points at 2 Months After Radiofrequency Ablation (RFA)	2 months after radiofrequency ablation (RFA)	Difference in maximum pain scores between inclusion and 2 months after radiofrequency ablation (RFA) according to an 11-point numerical scale Rate of patients with a decrease of two or more points in their most intense pain, 2 months after the radiofrequency ablation. This rate is calculated for the evaluable population for the principal outcome measure. This rate is equal to the ratio of the number of patients with a decrease of two or more points in their maximum pain divided by the size of the evaluable population. The response rate considered acceptable is 50%, above this threshold the treatment will be considered potentially effective and may be proposed in phase III.

Secondary Outcome Measures

Name	Time	Method
Difference in Maximum Pain Scores Between Inclusion and 2 Months After Radiofrequency Ablation	Inclusion and 2 months after radiofrequency ablation (RFA)	Difference in maximum pain scores between inclusion and 2 months after radiofrequency ablation (RFA) according to a discrete 11-points numerical scale. Increased/decreased pain is considered as a variation of at least one point on the numerical scale. If 25 patients or more are observed with pain reduction of 2 or more points, then the treatment will be considered potentially effective.
Intensity of Pain (Minimum, Average, Maximum)	Algology assessment 3 months after radiofrequency	According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at: * Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation, * Inclusion visit: Second algology assessment (One week after the first algology assessment) * J-1: one day before radiofrequency * J+1: One day after radiofrequency * Discharge from hospital * 7 days after discharge from hospital * 1 month after radiofrequency * 2 months after radiofrequency * 3 months after radiofrequency Here, are presented only data collected 3 months after radiofrequency.
Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day	3 months after radiofrequency	Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency.
Total Intravenous Morphine Dose (mg)	24 hours after radiofrequency	Total intravenous dose of morphine 24 hours after the radiofrequency was assessed during the patient's hospital stay. As a reminder, the post-operative analgesic treatment included intravenous paracetamol (4 g / 24h) and patient-controlled analgesia (PCA).
Bolus Dose in mg Administered by Patient-controlled Analgesia (PCA)	24 hours after radiofrequency	As a reminder, the post-operative analgesic treatment included intravenous paracetamol (4 g / 24h) and patient-controlled analgesia (PCA).
Standardised Quality of Life Scores (EORTC - QLQ-C30)	2 months after radiofrequency	Quality of life Questionnaire -Core 30 (QLQ-C30) developed in 1986 by the European Organization for Research and Treatment of Cancer (EORTC) assesses quality of life across 15 dimensions : 5 functional dimensions : Physical functioning, Role functioning, Emotional, Cognitive functioning, Social functioning; 9 symptomatic dimensions: Fatigue, Nausea and vomiting, Pain, Dyspnea, Insomnia, Appetite loss, Diarrhoea, Financial difficulties; 1 global health dimension: Global health status/QoL Each dimension is a standardised score ranges from 0 to 100. A low score corresponds to a low functional level, an absence of symptoms or a low level of QoL/ overall health and, conversely, so that a high score corresponds to a high functional level, a high presence of symptoms or a high level of QoL/overall health.