Morphine After Radiofrequency Ablation of Painful Bone Metastases in Patients With Cancer
Condition: Metastatic Cancer; Pain; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Neoplasm Metastasis
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Acetaminophen; Morphine Sulfate; Questionnaire administration; Quality-of-life assessment; Radiofrequency ablation
Intervention type(s): Drug; Drug; Other; Procedure; Procedure
Intervention description(s): Intravenous administration of paracetamol (4 g / 24h) and patient-controlled analgesia (PCA).; 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.; 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; 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.; 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.
Other intervention name(s): Paracetamol; Oral morphine equivalent
Intervention MeSH terms: Acetaminophen; Morphine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: bone metastases; unspecified adult solid tumor, protocol specific; pain