Metastatic Cancer, Pain, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
bone metastases, unspecified adult solid tumor, protocol specific, pain
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.
Interventions
DRUGAcetaminophen
Intravenous administration of paracetamol (4 g / 24h) and patient-controlled analgesia (PCA).
DRUGMorphine 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.
OTHERQuestionnaire 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
PROCEDUREQuality-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.
PROCEDURERadiofrequency 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.
Sponsors
Institut Bergonié
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Intensity of Pain (Minimum, Average, Maximum) | First algology assessment at pre-selection visit | 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 at the pre-selection visit. |
| Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day | Preselection: First algology visit (within a week (± 3 days) after the radiology consultation) | 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. |
| 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. |
| 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) | Inclusion | 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. |
| 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). |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases 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. | 78 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 8 |
| Overall Study | Protocol Violation | 11 |
| Overall Study | Radiofrequency not done | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | — |
|---|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 11.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment France | 78 participants | — |
| Sex: Female, Male Female | 48 Participants | — |
| Sex: Female, Male Male | 30 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 10 / 71 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 33 / 71 |
Outcome results
Primary
Percentage of Participants With Maximum Pain Level Decreased by ≥ 2 Points at 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.
Time frame: 2 months after radiofrequency ablation (RFA)
Population: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.~If 25 patients or more are observed with pain reduction of 2 or more points, then the treatment will be considered potentially effective.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Percentage of Participants With Maximum Pain Level Decreased by ≥ 2 Points at 2 Months After Radiofrequency Ablation (RFA) | 83.6 percentage of participants |
Secondary
Bolus Dose in mg Administered by Patient-controlled Analgesia (PCA)
As a reminder, the post-operative analgesic treatment included intravenous paracetamol (4 g / 24h) and patient-controlled analgesia (PCA).
Time frame: 24 hours after radiofrequency
Population: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Bolus Dose in mg Administered by Patient-controlled Analgesia (PCA) | 1.0 mg | Standard Deviation 6.1 |
Secondary
Difference in Maximum Pain Scores Between Inclusion and 2 Months After Radiofrequency Ablation
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.
Time frame: Inclusion and 2 months after radiofrequency ablation (RFA)
Population: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Difference in Maximum Pain Scores Between Inclusion and 2 Months After Radiofrequency Ablation | Increased pain | 4 Participants |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Difference in Maximum Pain Scores Between Inclusion and 2 Months After Radiofrequency Ablation | Unchanged pain | 2 Participants |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Difference in Maximum Pain Scores Between Inclusion and 2 Months After Radiofrequency Ablation | Decreased pain | 49 Participants |
Secondary
Intensity of Pain (Minimum, Average, Maximum)
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 one day before radiofrequency (J-1).
Time frame: Algology assessment one day before radiofrequency (J-1)
Population: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Intensity of Pain (Minimum, Average, Maximum) | Minimal pain | 2.0 score on a scale | Standard Deviation 1.7 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Intensity of Pain (Minimum, Average, Maximum) | Average pain | 5.0 score on a scale | Standard Deviation 1.7 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Intensity of Pain (Minimum, Average, Maximum) | Maximum pain | 7.0 score on a scale | Standard Deviation 1.6 |
Secondary
Intensity of Pain (Minimum, Average, Maximum)
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 one day after radiofrequency (J+1).
Time frame: Algology assessment one day after radiofrequency: J+1
Population: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Intensity of Pain (Minimum, Average, Maximum) | Minimal pain | 0.0 score on a scale | Standard Deviation 1.6 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Intensity of Pain (Minimum, Average, Maximum) | Average pain | 2.0 score on a scale | Standard Deviation 2 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Intensity of Pain (Minimum, Average, Maximum) | Maximum pain | 4.0 score on a scale | Standard Deviation 2.7 |
Secondary
Intensity of Pain (Minimum, Average, Maximum)
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 at the discharge from hospital visit.
Time frame: Algology assessment at the discharge from hospital visit
Population: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Intensity of Pain (Minimum, Average, Maximum) | Minimal pain | 0.0 score on a scale | Standard Deviation 1.4 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Intensity of Pain (Minimum, Average, Maximum) | Average pain | 2.0 score on a scale | Standard Deviation 1.8 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Intensity of Pain (Minimum, Average, Maximum) | Maximum pain | 3.0 score on a scale | Standard Deviation 2.6 |
Secondary
Intensity of Pain (Minimum, Average, Maximum)
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 7 days after discharge from hospital.
Time frame: Algology assessment 7 days after discharge from hospital
Population: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Intensity of Pain (Minimum, Average, Maximum) | Minimal pain | 0.0 score on a scale | Standard Deviation 2 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Intensity of Pain (Minimum, Average, Maximum) | Average pain | 2.0 score on a scale | Standard Deviation 2.7 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Intensity of Pain (Minimum, Average, Maximum) | Maximum pain | 6.0 score on a scale | Standard Deviation 3.1 |
Secondary
Intensity of Pain (Minimum, Average, Maximum)
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 1 month after radiofrequency.
Time frame: Algology assessment 1 month after radiofrequency
Population: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Intensity of Pain (Minimum, Average, Maximum) | Minimal pain | 0.0 score on a scale | Standard Deviation 1.1 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Intensity of Pain (Minimum, Average, Maximum) | Average pain | 2.0 score on a scale | Standard Deviation 2 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Intensity of Pain (Minimum, Average, Maximum) | Maximum pain | 3.0 score on a scale | Standard Deviation 2.6 |
Secondary
Intensity of Pain (Minimum, Average, Maximum)
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 2 months after radiofrequency.
Time frame: Algology assessment 2 months after radiofrequency
Population: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Intensity of Pain (Minimum, Average, Maximum) | Minimal pain | 0.0 score on a scale | Standard Deviation 1.1 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Intensity of Pain (Minimum, Average, Maximum) | Average pain | 2.0 score on a scale | Standard Deviation 2.1 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Intensity of Pain (Minimum, Average, Maximum) | Maximum pain | 3.0 score on a scale | Standard Deviation 2.7 |
Secondary
Intensity of Pain (Minimum, Average, Maximum)
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.
Time frame: Algology assessment 3 months after radiofrequency
Population: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Intensity of Pain (Minimum, Average, Maximum) | Minimal pain | 0.0 score on a scale | Standard Deviation 1.2 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Intensity of Pain (Minimum, Average, Maximum) | Average pain | 1.0 score on a scale | Standard Deviation 2.3 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Intensity of Pain (Minimum, Average, Maximum) | Maximum pain | 2.5 score on a scale | Standard Deviation 2.9 |
Secondary
Intensity of Pain (Minimum, Average, Maximum)
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 at the pre-selection visit.
Time frame: First algology assessment at pre-selection visit
Population: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Intensity of Pain (Minimum, Average, Maximum) | Minimal pain | 0.5 score on a scale | Standard Deviation 1.9 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Intensity of Pain (Minimum, Average, Maximum) | Average pain | 5.0 score on a scale | Standard Deviation 1.9 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Intensity of Pain (Minimum, Average, Maximum) | Maximum pain | 8.0 score on a scale | Standard Deviation 1.4 |
Secondary
Intensity of Pain (Minimum, Average, Maximum)
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 at the inclusion visit.
Time frame: Second algology assessment at inclusion visit
Population: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Intensity of Pain (Minimum, Average, Maximum) | Minimal pain | 2.0 score on a scale | Standard Deviation 2 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Intensity of Pain (Minimum, Average, Maximum) | Average pain | 5.0 score on a scale | Standard Deviation 1.8 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Intensity of Pain (Minimum, Average, Maximum) | Maximum pain | 8.0 score on a scale | Standard Deviation 1.4 |
Secondary
Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
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.
Time frame: Preselection: First algology visit (within a week (± 3 days) after the radiology consultation)
Population: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day | 60.0 mg morphine equivalents/day | Standard Deviation 182.9 |
Secondary
Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
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.
Time frame: J-1 (One day before radiofrequency)
Population: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day | 60.0 mg morphine equivalents/day | Standard Deviation 132.8 |
Secondary
Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
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.
Time frame: Discharge from hospital
Population: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day | 60.0 mg morphine equivalents/day | Standard Deviation 115.3 |
Secondary
Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
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.
Time frame: 7 days after discharge
Population: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day | 60.0 mg morphine equivalents/day | Standard Deviation 103.1 |
Secondary
Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
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.
Time frame: 1 month after radiofrequency
Population: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day | 60.0 mg morphine equivalents/day | Standard Deviation 148 |
Secondary
Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
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.
Time frame: 2 months after radiofrequency
Population: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day | 60.0 mg morphine equivalents/day | Standard Deviation 148 |
Secondary
Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
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.
Time frame: 3 months after radiofrequency
Population: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day | 50.0 mg morphine equivalents/day | Standard Deviation 169.5 |
Secondary
Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
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.
Time frame: Inclusion: Second algology visit (One week after the first algology visit)
Population: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day | 60.0 mg morphine equivalents/day | Standard Deviation 182.9 |
Secondary
Standardised Quality of Life Scores (EORTC - QLQ-C30)
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.
Time frame: 2 months after radiofrequency
Population: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Standardised Quality of Life Scores (EORTC - QLQ-C30) | Physical functioning | 60.0 score on a scale | Standard Deviation 23.9 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Standardised Quality of Life Scores (EORTC - QLQ-C30) | Role functioning | 50.0 score on a scale | Standard Deviation 29.9 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Standardised Quality of Life Scores (EORTC - QLQ-C30) | Emotional functioning | 62.5 score on a scale | Standard Deviation 20.8 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Standardised Quality of Life Scores (EORTC - QLQ-C30) | Cognitive functioning | 50.0 score on a scale | Standard Deviation 25.5 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Standardised Quality of Life Scores (EORTC - QLQ-C30) | Social functioning | 50.0 score on a scale | Standard Deviation 33.7 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Standardised Quality of Life Scores (EORTC - QLQ-C30) | Global health status/QoL | 50.0 score on a scale | Standard Deviation 19 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Standardised Quality of Life Scores (EORTC - QLQ-C30) | Fatigue | 55.6 score on a scale | Standard Deviation 25.7 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Standardised Quality of Life Scores (EORTC - QLQ-C30) | Nausea and vomiting | 0.0 score on a scale | Standard Deviation 21.3 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Standardised Quality of Life Scores (EORTC - QLQ-C30) | Pain | 50.0 score on a scale | Standard Deviation 28.2 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Standardised Quality of Life Scores (EORTC - QLQ-C30) | Dyspnoea | 33.3 score on a scale | Standard Deviation 33.2 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Standardised Quality of Life Scores (EORTC - QLQ-C30) | Insomnia | 33.3 score on a scale | Standard Deviation 35 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Standardised Quality of Life Scores (EORTC - QLQ-C30) | Appetite loss | 33.3 score on a scale | Standard Deviation 35 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Standardised Quality of Life Scores (EORTC - QLQ-C30) | Constipation | 33.3 score on a scale | Standard Deviation 37.4 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Standardised Quality of Life Scores (EORTC - QLQ-C30) | Diarrhoea | 0.0 score on a scale | Standard Deviation 23.8 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Standardised Quality of Life Scores (EORTC - QLQ-C30) | Financial difficulties | 0.0 score on a scale | Standard Deviation 16.9 |
Secondary
Standardised Quality of Life Scores (EORTC - QLQ-C30)
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.
Time frame: Inclusion
Population: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Standardised Quality of Life Scores (EORTC - QLQ-C30) | Physical functioning | 46.7 score on a scale | Standard Deviation 23.7 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Standardised Quality of Life Scores (EORTC - QLQ-C30) | Role functioning | 33.3 score on a scale | Standard Deviation 32.9 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Standardised Quality of Life Scores (EORTC - QLQ-C30) | Emotional functioning | 58.3 score on a scale | Standard Deviation 24.2 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Standardised Quality of Life Scores (EORTC - QLQ-C30) | Cognitive functioning | 66.7 score on a scale | Standard Deviation 25.6 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Standardised Quality of Life Scores (EORTC - QLQ-C30) | Social functioning | 33.3 score on a scale | Standard Deviation 25.6 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Standardised Quality of Life Scores (EORTC - QLQ-C30) | Global health status/QoL | 41.7 score on a scale | Standard Deviation 17.1 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Standardised Quality of Life Scores (EORTC - QLQ-C30) | Fatigue | 66.7 score on a scale | Standard Deviation 23.1 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Standardised Quality of Life Scores (EORTC - QLQ-C30) | Nausea and vomiting | 16.7 score on a scale | Standard Deviation 26.5 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Standardised Quality of Life Scores (EORTC - QLQ-C30) | Pain | 83.3 score on a scale | Standard Deviation 24.4 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Standardised Quality of Life Scores (EORTC - QLQ-C30) | Dyspnoea | 33.3 score on a scale | Standard Deviation 30.6 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Standardised Quality of Life Scores (EORTC - QLQ-C30) | Insomnia | 33.3 score on a scale | Standard Deviation 31.5 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Standardised Quality of Life Scores (EORTC - QLQ-C30) | Appetite loss | 0.0 score on a scale | Standard Deviation 36 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Standardised Quality of Life Scores (EORTC - QLQ-C30) | Constipation | 33.3 score on a scale | Standard Deviation 33.1 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Standardised Quality of Life Scores (EORTC - QLQ-C30) | Diarrhoea | 0.0 score on a scale | Standard Deviation 16.3 |
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Standardised Quality of Life Scores (EORTC - QLQ-C30) | Financial difficulties | 0.0 score on a scale | Standard Deviation 26.3 |
Secondary
Total Intravenous Morphine Dose (mg)
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).
Time frame: 24 hours after radiofrequency
Population: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Total Intravenous Morphine Dose (mg) | 3.0 mg | Standard Deviation 72.4 |