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

Launched by ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE · Dec 18, 2015

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with severe cancer pain that does not respond well to standard opioid medications. It focuses on using a specialized type of radiation therapy called Gamma Knife radiosurgery to target the pituitary gland, which may help relieve pain related to multiple bone metastases, or cancer that has spread to the bones. The idea is that this treatment could reduce pain quickly, often within two days, and potentially allow patients to lower or stop their opioid use, which can have unpleasant side effects.

To participate in this trial, eligible individuals must be at least 18 years old and have cancer with painful bone metastases that hasn't been effectively managed with opioids. Patients should be in a palliative care setting, meaning they are receiving care aimed at improving quality of life rather than curing the disease. Participants will receive the Gamma Knife treatment and be monitored for its effectiveness in managing their pain. This study aims to help improve pain management strategies for patients facing similar challenges in their cancer journey.

Gender

ALL

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