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Intrathecal Morphine Administration Using Implantable Pump With Continuous or Programmable Flow (PITAC)

Primary Purpose

Advanced Cancer, Intractable Pain

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Implantable pump with continuous flow
Implantable pump with programmable flow.
Sponsored by
Institut Cancerologie de l'Ouest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Cancer focused on measuring Pain, cancer, Intrathecal, analgesia, Morphine, Implantable pump

Eligibility Criteria

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

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.

Sites / Locations

  • ICO Paul Papin
  • Institut Bergonié
  • Centre Hospitalier
  • Centre Oscar Lambret
  • Hôpital Laennec
  • Polyclinique

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Intrathecal pump with continuous flow

Intrathecal pump with programmable flow.

Arm Description

After placement of the implantable pump, continuous flow is scheduled by physician and the patient can't modify it.

After placement of the implantable pump, programmable flow is scheduled by physician and patient can do himself morphine bolus injections for a better control of acute episodes of pain.

Outcomes

Primary Outcome Measures

Pain improvement between 2 groups.
Pain will be assessed every day by patient using a Visual Analog Scale (VAS. VAS scores will be compared between 2 groups(continuous or programmable flow). We want to demonstrate the superiority of intrathecal analgesia obtained through programmable flow compared to continuous flow.

Secondary Outcome Measures

Pain improvement with intrathecal analgesia compared to previous antalgic therapy.
Using Visual Analog Scale's score, we want to demonstrate the superiority of intrathecal analgesia compared to previous treatment (pain is assessed through VAS within 4 days before inclusion).
Adverse Events assessment.
We want to demonstrate a reduction of adverse events related to intrathecal analgesia compared to the previous treatment and to compare the two delivery systems. Adverse events due to morphine (6 types) will be scored according to 4 levels, then the sum of these scores will constitute an adverse event severity index ranging from 0 to 18. This index will be compared between the 2 arms and will also be compared to baseline values before introduction of intrathecal analgesia.
Patient's performance status improvement.
We want to demonstrate improvement of the patient's performance status during intrathecal analgesia compared to the previous treatment and to compare the two delivery systems.
Incidence and types of complications.
We want to compare the incidence and type of complications (infectious, morphine-related and co-analgesic treatments-related, due to the intrathecal catheter, to the implantable pump) between the two delivery systems.

Full Information

First Posted
March 22, 2012
Last Updated
March 23, 2020
Sponsor
Institut Cancerologie de l'Ouest
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1. Study Identification

Unique Protocol Identification Number
NCT01567345
Brief Title
Intrathecal Morphine Administration Using Implantable Pump With Continuous or Programmable Flow
Acronym
PITAC
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 14, 2009 (Actual)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Cancerologie de l'Ouest

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Cancer, Intractable Pain
Keywords
Pain, cancer, Intrathecal, analgesia, Morphine, Implantable pump

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intrathecal pump with continuous flow
Arm Type
Active Comparator
Arm Description
After placement of the implantable pump, continuous flow is scheduled by physician and the patient can't modify it.
Arm Title
Intrathecal pump with programmable flow.
Arm Type
Experimental
Arm Description
After placement of the implantable pump, programmable flow is scheduled by physician and patient can do himself morphine bolus injections for a better control of acute episodes of pain.
Intervention Type
Device
Intervention Name(s)
Implantable pump with continuous flow
Other Intervention Name(s)
Isomed Pump 8472
Intervention Description
Insertion of an implantable pump filled up with the analgesic solution. Connection of the catheter to the intrathecal space. Continuous morphine's flow is scheduled.
Intervention Type
Device
Intervention Name(s)
Implantable pump with programmable flow.
Other Intervention Name(s)
Synchromed II pump 8637
Intervention Description
Insertion of an implantable pump filled up with the analgesic solution. Connection of the catheter to the intrathecal space. Programmable morphine's flow is scheduled.
Primary Outcome Measure Information:
Title
Pain improvement between 2 groups.
Description
Pain will be assessed every day by patient using a Visual Analog Scale (VAS. VAS scores will be compared between 2 groups(continuous or programmable flow). We want to demonstrate the superiority of intrathecal analgesia obtained through programmable flow compared to continuous flow.
Time Frame
At 3 month
Secondary Outcome Measure Information:
Title
Pain improvement with intrathecal analgesia compared to previous antalgic therapy.
Description
Using Visual Analog Scale's score, we want to demonstrate the superiority of intrathecal analgesia compared to previous treatment (pain is assessed through VAS within 4 days before inclusion).
Time Frame
at 3 month
Title
Adverse Events assessment.
Description
We want to demonstrate a reduction of adverse events related to intrathecal analgesia compared to the previous treatment and to compare the two delivery systems. Adverse events due to morphine (6 types) will be scored according to 4 levels, then the sum of these scores will constitute an adverse event severity index ranging from 0 to 18. This index will be compared between the 2 arms and will also be compared to baseline values before introduction of intrathecal analgesia.
Time Frame
every month
Title
Patient's performance status improvement.
Description
We want to demonstrate improvement of the patient's performance status during intrathecal analgesia compared to the previous treatment and to compare the two delivery systems.
Time Frame
At 1 month
Title
Incidence and types of complications.
Description
We want to compare the incidence and type of complications (infectious, morphine-related and co-analgesic treatments-related, due to the intrathecal catheter, to the implantable pump) between the two delivery systems.
Time Frame
every month.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis Dupoiron, MD
Organizational Affiliation
Institut Cancerologie de l'Ouest
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICO Paul Papin
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Institut Bergonié
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Hospitalier
City
Laon
ZIP/Postal Code
02001
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
53020
Country
France
Facility Name
Hôpital Laennec
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Polyclinique
City
Poitiers
ZIP/Postal Code
86000
Country
France

12. IPD Sharing Statement

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Intrathecal Morphine Administration Using Implantable Pump With Continuous or Programmable Flow

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