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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A00616-43 | Registry Identifier | IDRCB | |
| RCAPHM15_0022 | Other Identifier | APHM |
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80% of palliative care cancer patients suffer from severe pain. The management of these pain improves the quality of life of these patients. The management of opioid pain refractory to date remains a difficulty for caregivers. Hypophysectomy performed to try to control hormone-dependent neoplasia also help relieve pain associated with lesions secondary cancer. The surgical hypophysialis radio Gamma Knife ® was recently performed on a small number of patients. She would have the advantage of reducing the risk of complications compared to other techniques and achieve similar analgesic effect on diffuse, or mixed nociceptive pain associated with metastases on average in 2 days and would reduce or stop opiates most often responsible for side effects impairing the quality of life. The objective of this clinical trial, multicenter, prospective, randomized controlled is to evaluate the effectiveness of surgical hypophysialis radio for patients in palliative situations with refractory cancer pain in opioid level III. The type of pain "cancer pain" was done in order to optimize the recruitment and homogenization of the study population: patients cared for in palliative care units are mostly patients cancer (70-80%). This study is therefore part of a palliative setting and the results of this test can be extrapolated to other populations of palliative patients with refractory pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pituitary radiosurgery group | Experimental | Subjects will receive a pituitary radiosurgery by GammaKnife® during a brief hospitalization associated with standards of care for pain according to recommendations (Standards, Options and Recommendations about drug analgesic treatments for nociceptive cancer pain in adults) |
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| Control group | Active Comparator | Subject will receive standards of care for pain according to recommendations (Standards, Options and Recommendations about drug analgesic treatments for nociceptive cancer pain in adults) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GammaKnife® | Device |
| ||
| 18F-2-fluoro-2-deoxy-D-glucose - positron emission tomography (FDG-PET) |
| Measure | Description | Time Frame |
|---|---|---|
| The pain assessment | using the Numeric Pain Intensity Scale (NPSI) | 36 months |
| The pain assessment | Neuropathic pain questionnaire (DN4) | 36 months |
| The pain assessment | Self-reported pain and Quality of life | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| assessment of the visual fields | visual perimeter test | 36 months |
| assessment of the visual acuity | exploration test macular function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| DESALBRES Urielle, Director | Contact | 0491382747 | drci@ap-hm.fr | |
| DHORNE Jean, Manager | Contact | 0491381475 | jean.dhorne@ap-hm.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique Hôpitaux de Marseille | Recruiting | Marseille | 13354 | France |
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| Device |
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| MRI | Device |
|
| 36 months |
| endocrine balance | Rate of Corticotropic in the blood | 36 months |
| endocrine balance | Rate of Gonadotropic in the blood | 36 months |
| endocrine balance | Rate of Somatotropic in the blood | 36 months |
| endocrine balance | Rate of Thyrotropic in the blood | 36 months |
| Pituitary morphology | MRI with gadolinium | 36 months |
| evaluate metabolic consumption of glucose | FDG-PET | 36 mois |
| evaluate metabolic connectivity at resting-state | 18F-2-fluoro-2-deoxy-D-glucose - positron emission tomography (FDG-PET) | 36 mois |