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Compares treatment options for Intrathecal Drug Delivery
Official title Intrathecal Therapy Versus Standard Care for Severe Cancer Pain
ClinicalTrials.gov ID: NCT07691840
What this study is testing
What is Comprehensive Medical Management?
Comprehensive Medical Management is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for intrathecal drug delivery.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Approximately 66% of patients with advanced cancer experience pain, which is often inadequately controlled and associated with a decline in health-related quality of life (HRQoL). Conventional pharmacologic management, ranging from simple analgesics to strong opioids, is frequently limited by insufficient efficacy and systemic side effects.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patients (≥18 years) with severe cancer refractory pain (all types of cancer), who have been receiving treatment with oral/systemic opioids for...
- Intrathecal therapy is recommended because of inefficacy or intolerance to strong systemic opioid treatment. Inefficacy is defined as mean daily...
- Patients suitable for IDD and with the ability to comply with the medical protocol and visits.
- Survival prognosis of ≥ 6 months.
You likely can't join if
- Patients with active, severe infection.
- Patients with known brain metastases.
- Patients with high risk of hemorrhaging.
- Patients with respiratory depression (for use of morphine).
- Patients with severe respiratory compromise; baseline oxygen SpO2 \< 90%, chronic CO2 retention.
- Patients with severe cardiac disease or risk of cardiotoxicity (for use of bupivacaine).
See the full eligibility criteria
- Adult patients (≥18 years) with severe cancer refractory pain (all types of cancer), who have been receiving treatment with oral/systemic opioids for at least 4 weeks, and are expected to remain on opioids for the...
- Intrathecal therapy is recommended because of inefficacy or intolerance to strong systemic opioid treatment. Inefficacy is defined as mean daily visual analogue scale (VAS) pain intensity score at rest of ≥ 50 mm...
- Patients suitable for IDD and with the ability to comply with the medical protocol and visits.
- Survival prognosis of ≥ 6 months.
- Patients with active, severe infection.
- Patients with known brain metastases.
- Patients with high risk of hemorrhaging.
- Patients with respiratory depression (for use of morphine).
- Patients with severe respiratory compromise; baseline oxygen SpO2 \< 90%, chronic CO2 retention.
- Patients with severe cardiac disease or risk of cardiotoxicity (for use of bupivacaine).
- Patients with severe liver impairment or liver failure (for use of ropivacaine).
- Patients with allergies for medication or IDD hardware.
- Pregnant or lactating women.
- Women who plan to become pregnant within 1 month after the study.
The study team makes the final eligibility decision.
Where it's taking place
- Jette, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jette, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.