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Comparing ziconotide and a drug combination to standard medical management for patients with severe cancer pain

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study aims to compare the use of a drug delivery system through the spine with standard medical care for individuals experiencing Severe refractory cancer pain, which is intense pain caused by cancer that does not respond well to typical treatments. One group will receive a medical management approach using standard medications, while the other group will use an intrathecal drug delivery system, a method where medication is delivered directly into the fluid surrounding the spinal cord. The medications used in this study include ziconotide, ropivacaine hydrochloride, morphine hydrochloride, and bupivacaine hydrochloride.

Participants in the study involving the delivery system will receive these substances through a specialized pump. This approach involves intrathecal use, meaning the drugs are placed into the space between the membranes that cover the spinal cord to target pain more directly. During the course of the study, participants will be monitored to assess their quality of life, comfort levels, and how they manage the physical and emotional challenges of their condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Assignment to a treatment group
Participation begins by being assigned to one of two different treatment paths to manage severe cancer pain.
Step 2
Intrathecal drug delivery system
One option involves using an intrathecal drug delivery system, which is a device that delivers medication directly into the fluid surrounding the spinal cord through a small tube.
The medications administered through this system include ziconotide at a dose of 21.60 micrograms, ropivacaine hydrochloride at 15 milligrams, morphine hydrochloride at 1500 micrograms, or bupivacaine hydrochloride at 15 milligrams.
Step 3
Comprehensive medical management
The other option involves comprehensive medical management, which refers to receiving standard pain medications and care provided by medical professionals through conventional methods.
Step 4
Monitoring and assessments
Throughout the treatment, quality of life is measured using a specific questionnaire.
Various aspects of well-being are evaluated, including physical, spiritual, environmental, and social comfort, as well as pain intensity, perceived stress, anxiety, and perceived injustice related to health status.
Levels of self-efficacy and the burden on caregivers are also assessed using specific scales.
Step 5
Ongoing follow-up
Monthly telephone interviews are conducted to gather information regarding healthcare costs, medical consultations, hospital admissions, changes in medication, or any adverse events, which are unexpected medical problems or side effects.
survival rates and safety are monitored from the start of the treatment.

Who can join the trial?

12 criteria

You must be an adult, which means you are 18 years of age or older.
You must have severe cancer pain that does not respond well to standard treatments, which is known as refractory pain.
You must have been taking opioids, which are strong medicines used to reduce pain, for at least 4 weeks.
You must be expected to continue taking opioids for the whole time you are in the study.
Before being included, you must have already tried changing your dose or type of opioid more than once, a process called opioid rotation.
You must be a candidate for intrathecal therapy, which is a way of delivering medicine directly into the fluid surrounding the spinal cord.
This therapy is recommended because your current systemic opioid treatment, which is medicine that travels through your entire body, is either not working well enough or is causing problems.
Your pain must be considered ineffective to treat, meaning your daily pain score on a scale of 0 to 100 is 50 or higher while resting.
Your treatment must be considered intolerable, meaning you have experienced adverse events, or harmful side effects, that prevent you from taking a higher dose of medicine to help with the pain.
You must be able to use an implanted drug delivery device (IDD), which is a small pump placed under the skin to provide medicine.
You must be able to follow the study rules and attend all scheduled medical appointments.
Doctors expect you to live for at least 3 months, which is known as your survival prognosis.

Who cannot join the trial?

6 criteria

Patients who currently have a serious or intense infection, which is when harmful germs like bacteria or viruses are actively making the body sick.
Patients who have brain metastases, which means cancer has spread from another part of the body to the brain.
Patients who have a high risk of hemorrhaging, which is the medical term for severe or uncontrolled bleeding.
Patients who have allergies, or harmful allergic reactions, to the medicines used in the study or to IDD hardware, which refers to medical devices implanted in the spine to treat disc problems.
Women who are currently pregnant or lactating, which means breastfeeding a baby.
Women who are planning to become pregnant within one month after the study ends.

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Vrije Universiteit Brussel
Jette, Belgium

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Investigated drugs

Ziconotide
is a medication administered directly into the fluid surrounding the spinal cord to help manage severe pain.
Ropivacaine
is a local anesthetic used to provide pain relief by being injected into the spinal area to numb the nerves.
Morphine
is a strong pain-relieving medication that is delivered into the spinal fluid to help manage intense pain.
Bupivacaine
is a type of local anesthetic injected into the spinal area to block pain signals.

What is already known about the treatment

Ziconotide
This medication is administered as a liquid solution through a small tube into the fluid surrounding the spinal cord. It is an established treatment used specifically for managing severe, long-term pain that does not respond well to other medicines. At a molecular level, it works by blocking specific calcium channels in the spinal cord, which prevents pain signals from being sent to the brain. It is classified as a non-opioid analgesic.
Ropivacaine hydrochloride
This drug is given as an injection directly into the fluid around the spinal cord. It is widely used in medical practice to provide numbness or pain relief during and after surgical procedures. It works by blocking the movement of sodium through nerve membranes, which stops the nerves from transmitting pain messages. It is categorized as a local anesthetic.
Morphine hydrochloride
This substance is administered via injection into the spinal fluid. It is a well-known and commonly used medication for managing intense, severe pain, such as that caused by advanced cancer. It works by attaching to specific receptors in the central nervous system to change how the brain perceives and responds to pain. It belongs to a class of drugs known as opioids.
Bupivacaine hydrochloride
This medication is delivered through an injection into the area surrounding the spinal cord. It is a standard treatment used in hospitals to provide localized numbness for pain relief during medical procedures. It functions by interfering with the electrical signals in nerve cells, effectively stopping the transmission of pain. It is classified as a local anesthetic.

Investigated diseases

Severe refractory cancer pain - This condition involves intense physical discomfort caused by the presence of malignant tumors. It is characterized by pain that does not respond well to standard pain management approaches. As the underlying cancer progresses, the sensations typically become more persistent and difficult to manage. The discomfort may vary in intensity and can affect different parts of the body depending on the location of the cancer. Over time, the pain often becomes more continuous as the disease advances.