Metastatic CancerPhase 2MEDORNCT00712712
Morphine After Radiofrequency Ablation of Painful Bone Metastases in Patients With Cancer
A Phase 2 study testing Acetaminophen, Morphine Sulfate and Questionnaire administration in people with Metastatic Cancer and Pain, run by Institut Bergonié at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Cancer, Pain, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- Acetaminophen, Morphine Sulfate and Questionnaire administration
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteFrance
- Study dates
- 24 Dec 2007to 16 Mar 2016
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effectiveness of the Radiofrequency Ablation for Reducing Refractory Pain From Bone Metastases
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.
Read the 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.
- Being tested
- Acetaminophen, Morphine Sulfate, Questionnaire administration, Quality-of-life assessment, Radiofrequency ablation
- Keywords
- bone metastases, unspecified adult solid tumor, protocol specific, pain
- Medical subject headings
- Neoplasm Metastasis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Also called Paracetamol
Intravenous administration of paracetamol (4 g / 24h) and patient-controlled analgesia (PCA).
Morphine SulfateDrug
Also called Oral morphine equivalent
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 or surgery
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 or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient who has undergone radiofrequency ablation of bone metastases | Experimental | 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. Receives: Drug: Acetaminophen; Drug: Morphine Sulfate; Other: Questionnaire administration; Procedure: Quality-of-life assessment; Procedure: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months after radiofrequency ablation (RFA)
Secondary outcomes (22)
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.
Measured: Inclusion and 2 months after radiofrequency ablation (RFA)
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.
Measured: First algology assessment at pre-selection visit
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.
Measured: Second algology assessment at inclusion visit
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).
Measured: Algology assessment one day before radiofrequency (J-1)
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).
Measured: Algology assessment one day after radiofrequency: J+1
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.
Measured: Algology assessment at the discharge from hospital visit
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.
Measured: Algology assessment 7 days after discharge from hospital
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.
Measured: Algology assessment 1 month after radiofrequency
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.
Measured: Algology assessment 2 months after radiofrequency
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.
Measured: Algology assessment 3 months after radiofrequency
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.
Measured: Preselection: First algology visit (within a week (± 3 days) after the radiology consultation)
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.
Measured: Inclusion: Second algology visit (One week after the first algology visit)
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.
Measured: J-1 (One day before radiofrequency)
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.
Measured: Discharge from hospital
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.
Measured: 7 days after discharge
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.
Measured: 1 month after radiofrequency
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.
Measured: 2 months after radiofrequency
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.
Measured: 3 months after radiofrequency
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).
Measured: 24 hours after radiofrequency
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).
Measured: 24 hours after radiofrequency
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.
Measured: Inclusion
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.
Measured: 2 months after radiofrequency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2008 (estimated)
- Study start24 Dec 2007
- Primary completion11 Feb 2016
- Study completion16 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence Dixmerias, MD, Study chair, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712712
- Sponsor's protocol ID
- IB-2007-16
- Other IDs
- IB-MEDOR, INCA-RECF0498, 2007-002686-13
- Acronym
- MEDOR
- Status last verified
- Mar 2021
- First submitted
- 9 Jul 2008
- Last updated
- 29 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No