NCT00712712

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

Evaluation of the Effectiveness of the Radiofrequency Ablation for Reducing Refractory Pain From Bone Metastases

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Institut Bergonié · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Cancer
• Pain
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	Acetaminophen	Intravenous administration of paracetamol (4 g / 24h) and patient-controlled analgesia (PCA).
DRUG	Morphine Sulfate	Patient-controlled analgesia (PCA), allowing morphine consumption to be titrated to the patient's needs and thus allowing morphine doses to be adapted to an increase in pain in the patient's post-operative period or a rapid analgesic effect of radiofrequency.
OTHER	Questionnaire administration	Pain notebook will allow the patient to describe the pain specific to the metastasis concerned, containing information on : * The intensity of the minimum, average and maximum pain of the last 24 months. hours as well as the intensity of the pain of the moment according to a scale 11-point digital, * the background morphine analgesic treatment during the last 24 hours, * the morphine analgesic treatment taken during painful attacks, * the possible undesirable effects of morphine treatment. * the morphinic, non-morphinic and co-antalgic treatment is noted, as well as that the total dose of oral morphine or oral morphine equivalent
PROCEDURE	Quality-of-life assessment	Patients' quality of life will be assessed using the quality of life questionnaire EORTC QLQ-C30 at inclusion in the study and at 8 weeks after radiofrequency. ablation.
PROCEDURE	Radiofrequency ablation	Recent technique of thermal destruction of tumors. This technique consists of inserting an electrode needle into the tumour under X-ray or ultrasound guidance or intraoperatively under laparoscopy for example. This needle carries a current or a light wave depending on the characteristics of the generator to which it is connected (radiofrequency, laser). Radio frequencies are radiation non-ionising electromagnets. In this context of tissue ablathermia wavelengths ranging from 400kHz to 500kHz.

Timeline

• Start date: 2007-12-24
• Primary completion: 2016-02-11
• Completion: 2016-03-16
• First posted: 2008-07-10
• Last updated: 2025-08-29
• Results posted: 2021-03-26

Locations

1 site across 1 country: France