Pituitary Gland Stimulation for Cancer Pain Relief

Oncology Pain Clinical Trial

— PGS  

Official title:

Pituitary Gland Stimulation for Cancer Pain Relief

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05230238
• Other study ID #: P21.036
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2021
• Est. completion date: January 1, 2024

Study information

• Verified date: March 2023
• Source: Leiden University Medical Center
• Contact: Wouter van Furth, MD, Phd
• Phone: +31715162109
• Email: w.r.van_furth[@]lumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients will undergo an implantation of an extradural pituitary surface electrode in the pituitary fossa. The electrode will be attached to a neurostimulator via which the patient will receive up to 8 (patient requested) stimulations per day.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patient
• In palliative phase of metastatic disease, without options for further systemic treatment or radiotherapy
• Inadequately controlled pain with standard care
• Most prominent part of experienced pain is nociceptive
• Karnofsky Performance Score =30

Exclusion Criteria:

• Not fit for general anesthesia
• Pregnancy
• Unfavorable local anatomy for PGS, due to a disease process, or anatomical configuration
• Clinical signs of posterior pituitary gland disfunction
• Recent history of alcohol or drug abuse
• Severe immunodeficiency
• Need for anticoagulation therapy that cannot be abrogated for surgery
• Need for subsequent MRI-imaging
• Cognitive impairments prohibiting full understanding of study and ability to provide informed consent
• Not able to adequately communicate in Dutch or English

Related Conditions & MeSH terms

• Cancer Pain
• Oncology Pain

Intervention

Device:
• Pituitary gland stimulation
Pituitary gland stimulation via an surface electrode connected to an external neurostimulator

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived pain	Numeric Rating Scale (0= no pain, 10=most severe pain)	4 months
Primary	Pain Medication	Morphine Equivalent Doses for background and escape medication	4 months