Oncology PainPGSNCT05230238
Pituitary Gland Stimulation for Cancer Pain Relief
A study testing Pituitary gland stimulation in people with Oncology Pain, run by Leiden University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology Pain
- What is being tested?
- Pituitary gland stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Oct 2021to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden
Wouter van Furth, MD, PhD
About this study
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.
- Conditions
- Oncology Pain
- Being tested
- Pituitary gland stimulation
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pituitary gland stimulationDevice
Pituitary gland stimulation via an surface electrode connected to an external neurostimulator
| Study group | Role | What they receive |
|---|---|---|
| pituitary stimulation | Experimental | Patients will receive pituitary stimulation as oncology pain treatment. Receives: Device: Pituitary gland stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived pain
Numeric Rating Scale (0= no pain, 10=most severe pain)
Measured: 4 months
Pain Medication
Morphine Equivalent Doses for background and escape medication
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start12 Oct 2021
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oncology PainStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wrvanfurth, Leiden University Medical Center
- Investigators
- Wouter van Furth, MD, PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230238
- Sponsor's protocol ID
- P21.036
- Acronym
- PGS
- Status last verified
- Mar 2023
- First submitted
- 13 Jan 2022
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pituitary Gland Stimulation for Cancer Pain Relief
- ClinicalTrials.gov ID
- NCT05230238
- Acronym / sponsor ID
- PGS / P21.036
- Conditions
- Oncology Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pituitary stimulation | Experimental | Device: Pituitary gland stimulationPatients will receive pituitary stimulation as oncology pain treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pituitary gland stimulationPituitary gland stimulation via an surface electrode connected to an external neurostimulator | Device | pituitary stimulation |
Primary outcome
Perceived pain
Time frame: 4 months
Numeric Rating Scale (0= no pain, 10=most severe pain)
Pain Medication
Time frame: 4 months
Morphine Equivalent Doses for background and escape medication
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Oncology Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Not yet recruiting
Lung Cancer and Aging: Improving Well-being for Older Adults With Lung Cancer
Lung Cancer
Active, not recruitingPhase 3
Effect of Olanzapine on Opioid Craving and Misuse Among Patients Receiving Opioids for Cancer-related Pain: A Pilot Double-Blind, Randomized Control Trial
Misuse, Opioid
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wouter van Furth, MD, PhD principal investigator
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pituitary gland stimulation in people with Oncology Pain, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wouter van Furth, MD, Phd (+31715162109, w.r.van_furth@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived pain (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2023.