Pituitary Gland Stimulation for Cancer Pain Relief | NCT05230238

Studies
Pituitary Gland Stimulation for Cancer Pain Relief

NCT05230238

Sponsor

Leiden University Medical Center

Status

Unknown status

Last Update Posted

Mar 10, 2023Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Oncology Pain

Interventions

Pituitary gland stimulation

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 12, 2021Actual

Primary Completion Date

Jan 1, 2024Estimated

Completion Date

Jan 1, 2024Estimated

First Submitted Date

Jan 13, 2022

First Submission Date that Met QC Criteria

Jan 28, 2022

First Posted Date

Feb 8, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2023

Last Update Posted Date

Mar 10, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
pituitary stimulation	Experimental	Patients will receive pituitary stimulation as oncology pain treatment.	Device: Pituitary gland stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pituitary gland stimulation	Device	Pituitary gland stimulation via an surface electrode connected to an external neurostimulator	pituitary stimulation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wouter van Furth, MD, Phd	Contact	+31715162109		w.r.van_furth@lumc.nl

Overall Officials

Name	Affiliation	Role
Wouter van Furth, MD, PhD	Leiden University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Leiden University Medical Center	Recruiting	Leiden			Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Apr 17, 2025
Reset	May 5, 2025

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 17, 2025			May 5, 2025

Condition Browse Module

MeSH Terms

ID	Term
D000072716	Cancer Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided