Pituitary Gland Stimulation for Cancer Pain Relief (PGS)

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.

Study Overview

• Status: Recruiting
• Conditions: Oncology Pain
• Intervention / Treatment: Device: Pituitary gland stimulation

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wouter van Furth, MD, Phd; Phone Number: +31715162109; Email: w.r.van_furth@lumc.nl

Study Locations

• Netherlands
  • Leiden, Netherlands
    • Recruiting
    • Leiden University Medical Center
    • Contact: Wouter van Furth, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pituitary stimulation; Patients will receive pituitary stimulation as oncology pain treatment.	Device: Pituitary gland stimulation; Pituitary gland stimulation via an surface electrode connected to an external neurostimulator

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Leiden University Medical Center
• Investigators: Principal Investigator: Wouter van Furth, MD, PhD, Leiden University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2021
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: January 13, 2022
• First Submitted That Met QC Criteria: January 28, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain
• Other Study ID Numbers: P21.036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No