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
Intervention: Acetaminophen; Morphine Sulfate; Questionnaire administration; Quality-of-life assessment; Radiofrequency ablation
Intervention description: 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.
Intervention MeSH terms: Acetaminophen; Morphine
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: bone metastases; unspecified adult solid tumor, protocol specific; pain

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.
    

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