Using Gamma Knife radiosurgery to treat severe cancer pain unresponsive to opioids
Treatment of Opioid-refractory Pain (WHO Level III) by Pituitary Radiosurgery: A Multicenter, Prospective, Randomized Study
This study tests whether Gamma Knife radiosurgery can help cancer patients with severe pain from bone metastases who don't get relief from opioids.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique Hopitaux De Marseille Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Marseille) |
| Trial ID | NCT02637479 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of Gamma Knife radiosurgery in managing severe pain caused by multiple bone metastases in cancer patients who do not respond to standard opioid therapy. The study aims to assess how this innovative approach can alleviate pain and potentially reduce the reliance on opioids, which often have debilitating side effects. Participants will be monitored for pain relief and overall quality of life improvements over a specified period. The trial is multicenter, prospective, and randomized, ensuring a robust methodology for evaluating outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with nociceptive or mixed pain from multiple bone metastases that is refractory to standard opioid therapy.
Not a fit: Patients who are in the ultimate phase of cancer with an estimated survival of less than 48 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for cancer patients suffering from severe pain.
How similar studies have performed: While the use of Gamma Knife radiosurgery for pain management is relatively novel, preliminary results from small patient cohorts suggest potential effectiveness, though larger studies are needed to confirm these findings.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Marseille
- Assistance Publique Hôpitaux de Marseille — Marseille, France (Recruiting)
Study contacts
- Study coordinator: DESALBRES Urielle, Director
- Email: drci@ap-hm.fr
- Phone: 0491382747
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.