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PGS: Pituitary Gland Stimulation for Cancer Pain Relief

Sponsor
Leiden University Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05230238
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
26.6
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Pituitary gland stimulation
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pituitary Gland Stimulation for Cancer Pain Relief
Actual Study Start Date :
Oct 12, 2021
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Perceived pain [4 months]

    Numeric Rating Scale (0= no pain, 10=most severe pain)

  2. Pain Medication [4 months]

    Morphine Equivalent Doses for background and escape medication

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Leiden University Medical Center Leiden Netherlands

Sponsors and Collaborators

  • Leiden University Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
wrvanfurth, neurosurgeon, Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT05230238
Other Study ID Numbers:
  • P21.036
First Posted:
Feb 8, 2022
Last Update Posted:
Feb 8, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cancer Pain

Study Results

No Results Posted as of Feb 8, 2022