CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 78 enrolled
Drug / intervention
Acetaminophen +4 moredrug
Likely dose
Acetaminophen 4 gfrom record
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Search/NCT00712712
NCT00712712Phase 2Completed

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

Institut Bergonié·interventional·Posted Jul 10, 2008·Updated Aug 29, 2025

In Brief

A Phase 2 clinical trial evaluating Acetaminophen, Morphine Sulfate, and 3 other interventions for Metastatic Cancer and 2 related conditions. Completed, enrolled 78 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 10, 2008
Enrollment StartDec 24, 2007
Primary CompletionFeb 11, 2016
Study CompletionMar 16, 2016
TodayJul 2, 2026
Enrollment to primary: 8.1 yearsPosted 18.0 years ago

Interventions

Acetaminophendrug

Intravenous administration of paracetamol (4 g / 24h) and patient-controlled analgesia (PCA).

Morphine Sulfatedrug

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.

Questionnaire administrationother

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

Quality-of-life assessmentprocedure

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.

Radiofrequency ablationprocedure

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.