Treatment of Opioid-refractory Pain (WHO Level III) by Pituitary Radiosurgery (Hyporadoul)

Treatment of Opioid-refractory Pain (WHO Level III) by Pituitary Radiosurgery: A Multicenter, Prospective, Randomized Study

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.

Study Overview

• Status: Recruiting
• Conditions: Any Cancer With Multiple Bone Metastases
• Intervention / Treatment: Device: MRI; Device: GammaKnife®; Device: 18F-2-fluoro-2-deoxy-D-glucose - positron emission tomography (FDG-PET)

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: DESALBRES Urielle, Director; Phone Number: 0491382747; Email: drci@ap-hm.fr
• Study Contact Backup: Name: DHORNE Jean, Manager; Phone Number: 0491381475; Email: jean.dhorne@ap-hm.fr

Study Locations

• France
  • Marseille, France, 13354
    • Recruiting
    • Assistance Publique Hopitaux de Marseille
    • Contact: DESALBRES Urielle, Director; Phone Number: 0491382747; Email: drci@ap-hm.fr
    • Principal Investigator: REGIS Jean, PUPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Man or woman, aged 18 years or older;
• Subject suffering from nociceptive or mixed pain, not related to acts, refractory to standard opioid therapy
• Subject having a cancer defined by histology whatever the origin of the primitive cancer,
• Subject having multiple bone metastases
• Subject in palliative care state according to the definition given by the French Society of Palliative Care and Support
• Subject supported by structures of palliative care, pain or cancer involved in the study
• Inpatient and outpatient
• Subject without a curative cancer treatment and with or without palliative anticancer treatment;
• Subject non in "ultimate" phase (estimated survival superior at 48 h by a physician)
• Subject with acceptable general condition (Karnofsky performance Status Scale superior at 40
• Subject with a preserved vigilance defined from the Epworth scale
• Subject with preserved cognition according to the scale Basic Test Concentration, Memory and Guidance (TELECOM)
• Subject which can fill in a questionnaire, able to read or to understand the French language;
• Subject who signed an informed consent;
• Subject affiliated to the French health insurance system.

Exclusion Criteria:

• Subject with a curative cancer treatment
• Subject in "ultimate" phase (estimated by the physician of survival less than 48 hours)
• History of whole brain radiation
• History of radiosurgery of pituitary lodge
• Subject treated there less than a month by external or metabolic radiotherapy analgesic, surgical analgesic technic
• Subject minor, pregnant or breastfeeding, subject not being affiliated to the French health insurance system or private about freedom;
• Subject refusing to participate in the study or not signing the informed consent.
• Subject allergic to any component of Fludeoxyglucose (18F)
• Subject allergic to gadolinium salts.
• Subject with severe renal impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pituitary radiosurgery group; 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)	Device: MRI; Device: GammaKnife®; Device: 18F-2-fluoro-2-deoxy-D-glucose - positron emission tomography (FDG-PET)
Active Comparator: Control group; 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)	Device: 18F-2-fluoro-2-deoxy-D-glucose - positron emission tomography (FDG-PET)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of the visual fields	visual perimeter test	36 months
assessment of the visual acuity	exploration test macular function	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

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 15, 2015
• First Submitted That Met QC Criteria: December 18, 2015
• First Posted (Estimated): December 22, 2015

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 29, 2025
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pain, Intractable; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Antiviral Agents; Radiopharmaceuticals; Fluorodeoxyglucose F18; Deoxyglucose
• Other Study ID Numbers: 2014-51; 2015-A00616-43 (Registry Identifier: IDRCB); RCAPHM15_0022 (Other Identifier: APHM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No