Clinical trial NCT01567345: Intrathecal Morphine Administration Using Implantable Pump With Continuous or Programmable Flow
Official title: Comparison of Two Types of Intrathecal Morphine Administration by Pump for Analgesia in Cancer Patients With Failure of Conventional Analgesic Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Cancer
Intractable Pain
Keywords: Pain
cancer
Intrathecal
analgesia
Morphine
Implantable pump
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2012-03-30
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare intrathecal morphine administration: using a pump with continuous or programmable flow.

Detailed description: Cancer is frequently associated with pain. In spite of recent improvements in cancer related pain treatment, incidence of cancerous chronic pain did not decrease. Indeed, 15 to 20% of patients are still suffering from intractable pain despite an optimal symptom management.

Treatment of cancer pain is generally based on the WHO analgesic ladder according to 3 steps. Patients with advanced cancer are often treated at WHO step 3 analgesics, i.e. morphine and its derivatives, at high dosages. But increasing the dosage of opioids also leads to accentuation of their adverse events and the corresponding risks.

At this stage of the disease, in patients with failure of conventional analgesic therapy, intrathecal injection of analgesics can be decided in order to relieve pain. 2 types of pumps allow intrathecal morphine administration : continuous or programmable flow. In this study, we want to compare the quality of analgesia obtained through these 2 flows.

Eligibility criteria: Inclusion Criteria:

* Age \> or = 18 years old.
* Patient with advanced cancer.
* Patient with severe pain, i.e. a mean daily pain score \> or = 5 on an numeric rating scale.
* Failure of optimal conventional analgesic therapy : either due to intolerable adverse events or to lack of efficacy, i.e. after having tried opioid rotation techniques, different way of administration, use of rapid-acting narcotics to control acute episodes of pain, use of intravenous morphine by PCA pump.
* Possibility of return home
* Dated and signed informed consent form.

Exclusion Criteria:

* Patient's refusal to participate in the study.
* Ongoing pregnancy.
* Ongoing systemic infection.
* Injection site infection.
* Estimated survival less than 90 days.
* Allergy or intolerance to morphine.
* Contraindication to implantation of an intrathecal catheter.
* Patient treated with a powerful CYP1A2 inhibitor, such as fluvoxamine or enoxacin.
* Intrathecal chemotherapy planned.

Primary outcomes:
measure: Pain improvement between 2 groups.
timeFrame: At 3 month
Secondary outcomes:
measure: Pain improvement with intrathecal analgesia compared to previous antalgic therapy.
timeFrame: at 3 month
measure: Adverse Events assessment.
timeFrame: every month
measure: Patient's performance status improvement.
timeFrame: At 1 month
measure: Incidence and types of complications.
timeFrame: every month.
Other outcomes:
Locations:
city: Angers
country: France
facility: ICO Paul Papin
city: Bordeaux
country: France
facility: Institut Bergonié
city: Laon
country: France
facility: Centre Hospitalier
city: Lille
country: France
facility: Centre Oscar Lambret
city: Nantes
country: France
facility: Hôpital Laennec
city: Poitiers
country: France
facility: Polyclinique
Study officials:
affiliation: Institut Cancerologie de l'Ouest
name: Denis Dupoiron, MD
role: PRINCIPAL_INVESTIGATOR
References: