Pituitary Gland Stimulation for Cancer Pain Relief

Not Applicable

Recruiting

• Conditions: Oncology Pain
• Interventions: Device: Pituitary gland stimulation

• Registration Number: NCT05230238
• Lead Sponsor: Leiden University Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-12
• Study First Submitted: 2022-01-13
• Study First Submitted QC: 2022-01-28
• Study First Posted: 2022-02-08
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-09
• Last Update Posted: 2023-03-10
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pituitary stimulation	Pituitary gland stimulation	Patients will receive pituitary stimulation as oncology pain treatment.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands