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Pituitary Gland Stimulation for Cancer Pain Relief (PGS)

Primary Purpose

Oncology Pain

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Pituitary gland stimulation
Sponsored by
Leiden University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oncology Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Leiden University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pituitary stimulation

Arm Description

Patients will receive pituitary stimulation as oncology pain treatment.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 13, 2022
Last Updated
March 9, 2023
Sponsor
Leiden University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05230238
Brief Title
Pituitary Gland Stimulation for Cancer Pain Relief
Acronym
PGS
Official Title
Pituitary Gland Stimulation for Cancer Pain Relief
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2021 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Leiden University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oncology Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pituitary stimulation
Arm Type
Experimental
Arm Description
Patients will receive pituitary stimulation as oncology pain treatment.
Intervention Type
Device
Intervention Name(s)
Pituitary gland stimulation
Intervention Description
Pituitary gland stimulation via an surface electrode connected to an external neurostimulator
Primary Outcome Measure Information:
Title
Perceived pain
Description
Numeric Rating Scale (0= no pain, 10=most severe pain)
Time Frame
4 months
Title
Pain Medication
Description
Morphine Equivalent Doses for background and escape medication
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wouter van Furth, MD, Phd
Phone
+31715162109
Email
w.r.van_furth@lumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wouter van Furth, MD, PhD
Organizational Affiliation
Leiden University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leiden University Medical Center
City
Leiden
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wouter van Furth, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Pituitary Gland Stimulation for Cancer Pain Relief

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