Pituitary Gland Stimulation for Cancer Pain Relief (PGS)

Leiden University Medical Center (LUMC)

Status: Enrolling

Conditions: Oncology Pain

Treatments: Device: Pituitary gland stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05230238

P21.036

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

pituitary stimulation

Experimental group

Description:

Patients will receive pituitary stimulation as oncology pain treatment.

Treatment:

Device: Pituitary gland stimulation