Advanced CancerPITACNCT01567345
Intrathecal Morphine Administration Using Implantable Pump With Continuous or Programmable Flow
A study testing Implantable pump with continuous flow and Implantable pump with programmable flow. in people with Advanced Cancer and Intractable Pain, run by Institut Cancerologie de l'Ouest at 6 sites in France.
Trial summary
The aim of this study is to compare intrathecal morphine administration: using a pump with continuous or programmable flow. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Intractable Pain
- What is being tested?
- Implantable pump with continuous flow and Implantable pump with programmable flow.
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 6 sitesFrance
- Study dates
- 14 Jan 2009to Oct 2010
- 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
- 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.
Who cannot join
- 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.
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- Contraindication to implantation of an intrathecal catheter.
- Patient treated with a powerful CYP1A2 inhibitor, such as fluvoxamine or enoxacin.
- Intrathecal chemotherapy planned.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
ICO Paul Papin
Angers, 49933
Institut Bergonié
Bordeaux, 33076
Centre Hospitalier
Laon, 02001
Centre Oscar Lambret
Lille, 53020
Hôpital Laennec
Nantes, 44093
Polyclinique
Poitiers, 86000
About this study
Official title: Comparison of Two Types of Intrathecal Morphine Administration by Pump for Analgesia in Cancer Patients With Failure of Conventional Analgesic Therapy.
The aim of this study is to compare intrathecal morphine administration: using a pump with continuous or programmable flow.
Read the 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.
- Conditions
- Advanced Cancer, Intractable Pain
- Being tested
- Implantable pump with continuous flow, Implantable pump with programmable flow.
- Keywords
- Pain, cancer, Intrathecal, analgesia, Morphine, Implantable pump
- Medical subject headings
- Pain, Intractable, Pain, Neoplasms, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable pump with continuous flowDevice
Also called Isomed Pump 8472
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.
Implantable pump with programmable flow.Device
Also called Synchromed II pump 8637
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.
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal pump with continuous flow | Active comparator | After placement of the implantable pump, continuous flow is scheduled by physician and the patient can't modify it. Receives: Device: Implantable pump with continuous flow |
| Intrathecal pump with programmable flow. | Experimental | 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. Receives: Device: Implantable pump with programmable flow. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 3 month
Secondary outcomes (4)
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).
Measured: at 3 month
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.
Measured: every month
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.
Measured: At 1 month
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.
Measured: every month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study start14 Jan 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denis Dupoiron, MD, Principal investigator, Institut Cancerologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567345
- Sponsor's protocol ID
- CPP-401
- Other IDs
- 2008-005087-14, 2008
- Acronym
- PITAC
- Status last verified
- Aug 2024
- First submitted
- 22 Mar 2012
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Types of Intrathecal Morphine Administration by Pump for Analgesia in Cancer Patients With Failure of Conventional Analgesic Therapy.
- ClinicalTrials.gov ID
- NCT01567345
- Acronym / sponsor ID
- PITAC / CPP-401
- Conditions
- Advanced Cancer, Intractable Pain
- Keywords
- Pain, cancer, Intrathecal, analgesia, Morphine, Implantable pump
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 14 Jan 2009 (actual)
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 30 Mar 2012 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrathecal pump with continuous flow | Active comparator | Device: Implantable pump with continuous flowAfter placement of the implantable pump, continuous flow is scheduled by physician and the patient can't modify it. |
| Intrathecal pump with programmable flow. | Experimental | Device: Implantable pump with programmable flow.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- Patient's refusal to participate in the study.
- Ongoing pregnancy.
- Ongoing systemic infection.
- Injection site infection.
- Estimated survival less than 90 days.
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 |
|---|---|---|
| Implantable pump with continuous flowAlso: Isomed Pump 8472Insertion of an implantable pump filled up with the analgesic solution. Connection of the catheter to the intrathecal space. Continuous morphine's flow is scheduled. | Device | Intrathecal pump with continuous flow |
| Implantable pump with programmable flow.Also: Synchromed II pump 8637Insertion of an implantable pump filled up with the analgesic solution. Connection of the catheter to the intrathecal space. Programmable morphine's flow is scheduled. | Device | Intrathecal pump with programmable flow. |
Primary outcome
Pain improvement between 2 groups.
Time frame: At 3 month
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.
4 secondary outcomes
Pain improvement with intrathecal analgesia compared to previous antalgic therapy.
Time frame: at 3 month
Adverse Events assessment.
Time frame: every month
Patient's performance status improvement.
Time frame: At 1 month
Incidence and types of complications.
Time frame: every month.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
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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.
Denis Dupoiron, MD principal investigator
Institut Cancerologie de l'Ouest
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantable pump with continuous flow and Implantable pump with programmable flow. in people with Advanced Cancer and Intractable Pain, run by Institut Cancerologie de l'Ouest at 6 sites in France.
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 6 inclusion and 9 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: finished, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain improvement between 2 groups. (time frame: At 3 month). 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 2 Aug 2024.