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

Primary Purpose

Any Cancer With Multiple Bone Metastases

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
GammaKnife®
18F-2-fluoro-2-deoxy-D-glucose - positron emission tomography (FDG-PET)
MRI
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Any Cancer With Multiple Bone Metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assistance Publique Hôpitaux de MarseilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pituitary radiosurgery group

Control group

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

The pain assessment
using the Numeric Pain Intensity Scale (NPSI)
The pain assessment
Neuropathic pain questionnaire (DN4)
The pain assessment
Self-reported pain and Quality of life

Secondary Outcome Measures

assessment of the visual fields
visual perimeter test
assessment of the visual acuity
exploration test macular function
endocrine balance
Rate of Corticotropic in the blood
endocrine balance
Rate of Gonadotropic in the blood
endocrine balance
Rate of Somatotropic in the blood
endocrine balance
Rate of Thyrotropic in the blood
Pituitary morphology
MRI with gadolinium
evaluate metabolic consumption of glucose
FDG-PET
evaluate metabolic connectivity at resting-state
18F-2-fluoro-2-deoxy-D-glucose - positron emission tomography (FDG-PET)

Full Information

First Posted
December 15, 2015
Last Updated
December 18, 2015
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT02637479
Brief Title
Treatment of Opioid-refractory Pain (WHO Level III) by Pituitary Radiosurgery
Acronym
Hyporadoul
Official Title
Treatment of Opioid-refractory Pain (WHO Level III) by Pituitary Radiosurgery: A Multicenter, Prospective, Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Any Cancer With Multiple Bone Metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pituitary radiosurgery group
Arm Type
Experimental
Arm Description
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)
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
GammaKnife®
Intervention Type
Device
Intervention Name(s)
18F-2-fluoro-2-deoxy-D-glucose - positron emission tomography (FDG-PET)
Intervention Type
Device
Intervention Name(s)
MRI
Primary Outcome Measure Information:
Title
The pain assessment
Description
using the Numeric Pain Intensity Scale (NPSI)
Time Frame
36 months
Title
The pain assessment
Description
Neuropathic pain questionnaire (DN4)
Time Frame
36 months
Title
The pain assessment
Description
Self-reported pain and Quality of life
Time Frame
36 months
Secondary Outcome Measure Information:
Title
assessment of the visual fields
Description
visual perimeter test
Time Frame
36 months
Title
assessment of the visual acuity
Description
exploration test macular function
Time Frame
36 months
Title
endocrine balance
Description
Rate of Corticotropic in the blood
Time Frame
36 months
Title
endocrine balance
Description
Rate of Gonadotropic in the blood
Time Frame
36 months
Title
endocrine balance
Description
Rate of Somatotropic in the blood
Time Frame
36 months
Title
endocrine balance
Description
Rate of Thyrotropic in the blood
Time Frame
36 months
Title
Pituitary morphology
Description
MRI with gadolinium
Time Frame
36 months
Title
evaluate metabolic consumption of glucose
Description
FDG-PET
Time Frame
36 mois
Title
evaluate metabolic connectivity at resting-state
Description
18F-2-fluoro-2-deoxy-D-glucose - positron emission tomography (FDG-PET)
Time Frame
36 mois

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
DESALBRES Urielle, Director
Phone
0491382747
Email
drci@ap-hm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
DHORNE Jean, Manager
Phone
0491381475
Email
jean.dhorne@ap-hm.fr
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DESALBRES Urielle, Director
Phone
0491382747
Email
drci@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
REGIS Jean, PUPH

12. IPD Sharing Statement

Learn more about this trial

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

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