Morphine After Radiofrequency Ablation of Painful Bone Metastases in Patients With Cancer (MEDOR)
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Bordeaux、フランス、33076
- Institute Bergonie
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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Intravenous administration of paracetamol (4 g / 24h) and patient-controlled analgesia (PCA).
他の名前：
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.
他の名前：
Pain notebook will allow the patient to describe the pain specific to the metastasis concerned, containing information on :
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of Participants With Maximum Pain Level Decreased by ≥ 2 Points at 2 Months After Radiofrequency Ablation (RFA)
時間枠：2 months after radiofrequency ablation (RFA)
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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. |
2 months after radiofrequency ablation (RFA)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Difference in Maximum Pain Scores Between Inclusion and 2 Months After Radiofrequency Ablation
時間枠：Inclusion and 2 months after radiofrequency ablation (RFA)
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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. |
Inclusion and 2 months after radiofrequency ablation (RFA)
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Intensity of Pain (Minimum, Average, Maximum)
時間枠：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:
Here, are presented only data collected at the pre-selection visit. |
First algology assessment at pre-selection visit
|
|
Intensity of Pain (Minimum, Average, Maximum)
時間枠：Second algology assessment at inclusion 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:
Here, are presented only data collected at the inclusion visit. |
Second algology assessment at inclusion visit
|
|
Intensity of Pain (Minimum, Average, Maximum)
時間枠：Algology assessment one day before radiofrequency (J-1)
|
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:
Here, are presented only data collected one day before radiofrequency (J-1). |
Algology assessment one day before radiofrequency (J-1)
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Intensity of Pain (Minimum, Average, Maximum)
時間枠：Algology assessment one day after radiofrequency: J+1
|
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:
Here, are presented only data collected one day after radiofrequency (J+1). |
Algology assessment one day after radiofrequency: J+1
|
|
Intensity of Pain (Minimum, Average, Maximum)
時間枠：Algology assessment at the discharge from hospital 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:
Here, are presented only data collected at the discharge from hospital visit. |
Algology assessment at the discharge from hospital visit
|
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Intensity of Pain (Minimum, Average, Maximum)
時間枠：Algology assessment 7 days after discharge from hospital
|
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:
Here, are presented only data collected 7 days after discharge from hospital. |
Algology assessment 7 days after discharge from hospital
|
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Intensity of Pain (Minimum, Average, Maximum)
時間枠：Algology assessment 1 month after radiofrequency
|
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:
Here, are presented only data collected 1 month after radiofrequency. |
Algology assessment 1 month after radiofrequency
|
|
Intensity of Pain (Minimum, Average, Maximum)
時間枠：Algology assessment 2 months after radiofrequency
|
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:
Here, are presented only data collected 2 months after radiofrequency. |
Algology assessment 2 months after radiofrequency
|
|
Intensity of Pain (Minimum, Average, Maximum)
時間枠：Algology assessment 3 months after radiofrequency
|
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:
Here, are presented only data collected 3 months after radiofrequency. |
Algology assessment 3 months after radiofrequency
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Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
時間枠：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. |
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
時間枠：Inclusion: Second algology visit (One week after the first algology visit)
|
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. |
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
時間枠：J-1 (One day before radiofrequency)
|
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. |
J-1 (One day before radiofrequency)
|
|
Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
時間枠：Discharge from hospital
|
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. |
Discharge from hospital
|
|
Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
時間枠：7 days after discharge
|
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. |
7 days after discharge
|
|
Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
時間枠：1 month after radiofrequency
|
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. |
1 month after radiofrequency
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|
Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
時間枠：2 months after radiofrequency
|
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. |
2 months after radiofrequency
|
|
Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
時間枠：3 months after radiofrequency
|
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. |
3 months after radiofrequency
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Total Intravenous Morphine Dose (mg)
時間枠：24 hours after radiofrequency
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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). |
24 hours after radiofrequency
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Bolus Dose in mg Administered by Patient-controlled Analgesia (PCA)
時間枠：24 hours after radiofrequency
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As a reminder, the post-operative analgesic treatment included intravenous paracetamol (4 g / 24h) and patient-controlled analgesia (PCA).
|
24 hours after radiofrequency
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Standardised Quality of Life Scores (EORTC - QLQ-C30)
時間枠：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. |
Inclusion
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
時間枠：2 months after radiofrequency
|
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. |
2 months after radiofrequency
|
協力者と研究者
スポンサー
捜査官
- スタディチェア：Florence Dixmerias, MD、Institut Bergonie
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- CDR0000589594
- IB-MEDOR (その他の識別子：Institute Bergonie)
- IB-2007-16 (その他の識別子：Institute Bergonie)
- INCA-RECF0498 (その他の助成金/資金番号：INCA)
- 2007-002686-13 (EudraCT番号)
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