Any Cancer With Multiple Bone MetastasesHyporadoulNCT02637479
Treatment of Opioid-refractory Pain (WHO Level III) by Pituitary Radiosurgery
A study testing GammaKnife®, 18F-2-fluoro-2-deoxy-D-glucose - positron emission tomography (FDG-PET) and MRI in people with Any Cancer With Multiple Bone Metastases, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Any Cancer With Multiple Bone Metastases
- What is being tested?
- GammaKnife®, 18F-2-fluoro-2-deoxy-D-glucose - positron emission tomography (FDG-PET) and MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2015to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de Marseille
Marseille, 13354
DESALBRES Urielle, Director, 0491382747, drci@ap-hm.fr
REGIS Jean, PUPH
About this study
Official title: 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.
- Conditions
- Any Cancer With Multiple Bone Metastases
- Being tested
- GammaKnife®, 18F-2-fluoro-2-deoxy-D-glucose - positron emission tomography (FDG-PET), MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GammaKnife®Device
18F-2-fluoro-2-deoxy-D-glucose - positron emission tomography (FDG-PET)Device
MRIDevice
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: GammaKnife®; Device: 18F-2-fluoro-2-deoxy-D-glucose - positron emission tomography (FDG-PET); Device: MRI |
| 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) Receives: Device: 18F-2-fluoro-2-deoxy-D-glucose - positron emission tomography (FDG-PET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pain assessment
using the Numeric Pain Intensity Scale (NPSI)
Measured: 36 months
The pain assessment
Neuropathic pain questionnaire (DN4)
Measured: 36 months
The pain assessment
Self-reported pain and Quality of life
Measured: 36 months
Secondary outcomes (9)
assessment of the visual fields
visual perimeter test
Measured: 36 months
assessment of the visual acuity
exploration test macular function
Measured: 36 months
endocrine balance
Rate of Corticotropic in the blood
Measured: 36 months
endocrine balance
Rate of Gonadotropic in the blood
Measured: 36 months
endocrine balance
Rate of Somatotropic in the blood
Measured: 36 months
endocrine balance
Rate of Thyrotropic in the blood
Measured: 36 months
Pituitary morphology
MRI with gadolinium
Measured: 36 months
evaluate metabolic consumption of glucose
FDG-PET
Measured: 36 mois
evaluate metabolic connectivity at resting-state
18F-2-fluoro-2-deoxy-D-glucose - positron emission tomography (FDG-PET)
Measured: 36 mois
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Any Cancer With Multiple Bone MetastasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637479
- Sponsor's protocol ID
- 2014-51
- Other IDs
- 2015-A00616-43, RCAPHM15_0022
- Acronym
- Hyporadoul
- Status last verified
- Dec 2015
- First submitted
- 15 Dec 2015
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Opioid-refractory Pain (WHO Level III) by Pituitary Radiosurgery: A Multicenter, Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT02637479
- Acronym / sponsor ID
- Hyporadoul / 2014-51
- Conditions
- Any Cancer With Multiple Bone Metastases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pituitary radiosurgery group | Experimental | Device: GammaKnife®, Device: 18F-2-fluoro-2-deoxy-D-glucose - positron emission tomography (FDG-PET), Device: MRISubjects 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) |
| Control group | Active comparator | Device: 18F-2-fluoro-2-deoxy-D-glucose - positron emission tomography (FDG-PET)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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GammaKnife® | Device | Pituitary radiosurgery group |
| 18F-2-fluoro-2-deoxy-D-glucose - positron emission tomography (FDG-PET) | Device | Control group, Pituitary radiosurgery group |
| MRI | Device | Pituitary radiosurgery group |
Primary outcome
The pain assessment
Time frame: 36 months
using the Numeric Pain Intensity Scale (NPSI)
The pain assessment
Time frame: 36 months
Neuropathic pain questionnaire (DN4)
The pain assessment
Time frame: 36 months
Self-reported pain and Quality of life
9 secondary outcomes
assessment of the visual fields
Time frame: 36 months
assessment of the visual acuity
Time frame: 36 months
endocrine balance
Time frame: 36 months
endocrine balance
Time frame: 36 months
endocrine balance
Time frame: 36 months
endocrine balance
Time frame: 36 months
Pituitary morphology
Time frame: 36 months
evaluate metabolic consumption of glucose
Time frame: 36 mois
evaluate metabolic connectivity at resting-state
Time frame: 36 mois
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GammaKnife®, 18F-2-fluoro-2-deoxy-D-glucose - positron emission tomography (FDG-PET) and MRI in people with Any Cancer With Multiple Bone Metastases, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DESALBRES Urielle, Director (0491382747, drci@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pain assessment (time frame: 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.