To establish if targeted pituitary stimulation results in pain relief in cancer patients with opioid refractive pain or intolerance to opioids and patients with severe central neuropathic pain.
ID
Source
Brief title
Condition
- Other condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
- Central nervous system infections and inflammations
Synonym
Health condition
Oncogene pijn, centrale neuropathische pijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pain, defined as continuous or background pain, measured via a Numeric Rating
Scale and on the Brief Pain Inventory, corrected for medication use
Patient satisfaction with treatment
Treatment safety in terms of side effects
Secondary outcome
Use of analgetic medication
Hormone levels
Patient-reported outcome measures: pain interference, social role functioning,
cognitive functioning
Background summary
Pain relief in palliative cancer patients and central neuropathic pain patients
is mainly achieved via opioid administration, or other centrally acting
medication. However, some patients have medication refractive pain or are
intolerant to (high doses of) opioids. For these patients limited alternative
treatments are available. In the 1980*s, before the mass use of opioids,
hypophysectomy was used to treat these patients. Hypophysectomy had a strong
analgesic effects, but also severe side effects through pituitary hormone
depletion. Yanagida et al. showed that a single pituitary electrical
stimulation resulted in similar analgesic effects for 10 hours to 1 week with
limited side effects in 20 of 25 cancer patients. However, they only described
3 patients with an implanted electrode with ongoing stimulation treatment, all
of which experienced lasting satisfactory analgesia with no to limited side
effects.
In recent times, animal studies have shown an oxytocin-induced analgesic
effects in pituitary or hypothalamic stimulation. We hypothesize that through
pituitary stimulation oxytocin-induced analgesia can be established in pain
patients.
Study objective
To establish if targeted pituitary stimulation results in pain relief in cancer
patients with opioid refractive pain or intolerance to opioids and patients
with severe central neuropathic pain.
Study design
Open label, single arm, proof-of-concept feasibility study
Intervention
Patients will undergo an implantation of an extradural pituitary surface
electrode in the posterior pituitary fossa. The electrode will be attached to a
neurostimulator via which the patient can give himself up to 8 stimulations per
day.
Study burden and risks
Patients will undergo a surgical procedure to implant the electrode in the
extradural space of the sellar fossa. Thereafter, they will be asked to keep a
pain diary with pain scores on a numeric rating scale. They will asked to fill
in a questionnaire before the implantation and weekly during stimulation
treatment. There is a risk of complications of the surgery and side effects of
the stimulation. The surgery will be performed by experienced pituitary
neurosurgeons to limit the risk of complications. To limit potential side
effects, a targeted stimulation setting will be used and the pulse amplitude
will be titrated down to the lowest effective dose.
If our hypothesis is correct, this study has a strong beneficial effect for the
participants as pain relief will be established. This study will be performed
in patients with medication refractive pain or who are intolerant to opioids to
analyse the effect of treatment in the patient group at which it is targeted
and to not expose patients to risk and burden for whom a satisfactory treatment
is readily available.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
two patient categories are studied, with each their own set of inclusion
criteria
set one:
- Adult patient
- In palliative phase of metastatic disease
- Inadequately controlled pain with standard care
- Karnofsky Performance Score >=50
set two:
- Adult patient
- Diagnosed with central neuropathic pain
- Inadequately controlled pain with standard care
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
• Immunodeficiency
• Need for anticoagulation therapy that cannot be abrogated for surgery
• Cognitive impairments prohibiting full understanding of study and ability to
provide informed consent
• Not able to adequately communicate in Dutch or English
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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In other registers
| Register | ID |
|---|---|
| CCMO | NL76711.058.21 |