Treatment of Opioid-refractory Pain (WHO Level III) by Pituitary Radiosurgery (NCT02637479) | Clinical Trial Compass
UnknownNot Applicable
Treatment of Opioid-refractory Pain (WHO Level III) by Pituitary Radiosurgery
France40 participantsStarted 2015-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 m…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.