An interventional study of Implantable pump with continuous flow and Implantable pump with programmable flow. in Advanced Cancer and Intractable Pain, sponsored by Institut Cancerologie de l'Ouest. Completed at 6 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-02.
Sponsored by Institut Cancerologie de l'Ouest · Not applicable, Interventional, and Treatment
The aim of this study is to compare intrathecal morphine administration: using a pump with continuous or programmable flow.
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.
97 studies on the registry are indexed under Pain, Intractable; 18 are open to participants now.
This study's enrollment of 54 is close to the median of 60 across 66 interventional studies indexed under Pain, Intractable.
Browse Pain, Intractable studies →Institut Cancerologie de l'Ouest is the lead sponsor of 109 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
After placement of the implantable pump, continuous flow is scheduled by physician and the patient can't modify it.
Device: Implantable pump with continuous 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.
Device: Implantable pump with programmable flow.
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.
Also known as: Isomed Pump 8472
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.
Also known as: Synchromed II pump 8637
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.
Time frame: At 3 month
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: every month.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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