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

January 29, 2025 updated by: Assistance Publique Hopitaux De Marseille

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: DESALBRES Urielle, Director
  • Phone Number: 0491382747
  • Email: drci@ap-hm.fr

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The pain assessment
Time Frame: 36 months
using the Numeric Pain Intensity Scale (NPSI)
36 months
The pain assessment
Time Frame: 36 months
Neuropathic pain questionnaire (DN4)
36 months
The pain assessment
Time Frame: 36 months
Self-reported pain and Quality of life
36 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
assessment of the visual fields
Time Frame: 36 months
visual perimeter test
36 months
assessment of the visual acuity
Time Frame: 36 months
exploration test macular function
36 months
endocrine balance
Time Frame: 36 months
Rate of Corticotropic in the blood
36 months
endocrine balance
Time Frame: 36 months
Rate of Gonadotropic in the blood
36 months
endocrine balance
Time Frame: 36 months
Rate of Somatotropic in the blood
36 months
endocrine balance
Time Frame: 36 months
Rate of Thyrotropic in the blood
36 months
Pituitary morphology
Time Frame: 36 months
MRI with gadolinium
36 months
evaluate metabolic consumption of glucose
Time Frame: 36 mois
FDG-PET
36 mois
evaluate metabolic connectivity at resting-state
Time Frame: 36 mois
18F-2-fluoro-2-deoxy-D-glucose - positron emission tomography (FDG-PET)
36 mois

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique Hopitaux De Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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