Intrathecal Therapy Versus Standard Care for Severe Cancer Pain

Официальное название

Intrathecal Drug Delivery Systems Versus Comprehensive Medical Management for Severe Cancer Pain: a Randomized Controlled Trial

Обзор

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. Intrathecal drug delivery (IDD) offers targeted, continuous medication infusion directly into the intrathecal space, allowing lower systemic doses and potentially reducing side effects while maintaining effective analgesia. The CAREGIVER study is a randomized, controlled trial designed to evaluate whether patients with severe refractory cancer pain receiving IDD experience a difference in HRQoL compared to those receiving conventional medical management (CMM) with oral pain medications.

Вмешательства

• Процедура Intrathecal Drug Delivery
  Patients assigned to the IDD-group (intervention group) will undergo implantation of an IDD pump (Synchromed™, Medtronic). The device will be placed subcutaneously in the abdominal region and connected to a catheter delivering pain medication directly into the intrathecal space surrounding the spinal cord. At the time of implantation, the pump will be filled with medication, such as morphine, local anesthetics, or a combination thereof, and an initial daily dose will be selected. In the days fo
• Препарат Comprehensive Medical Management
  Participants randomized to the CMM-group will receive standard care.

Первичные конечные точки

• Health-related quality of life [Срок оценки: At baseline and 1, 2, 4, 6, 8, 10, and 12 months post-treatment initiation]

Вторичные конечные точки (11)

• Patient comfort [Срок оценки: At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation]
• Survival [Срок оценки: At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation]
• Pain intensity [Срок оценки: At baseline and 1, 2, 4, 6, 8, 10, and 12 months post-treatment initiation]
• Perceived stress [Срок оценки: At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation]
• Anxiety [Срок оценки: At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation]
• Perceived Injustice [Срок оценки: At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation]
• Self-efficacy [Срок оценки: At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation]
• Caregiver burden [Срок оценки: At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation]
• Health expenditure [Срок оценки: monthly after treatment initiation until 12 months]
• Safety [Срок оценки: Throughout the duration of the study, an average of 12 months.]
• Number of responders [Срок оценки: at 1, 2, 4, 6, and 12 months post-treatment initiation]

Критерии участия

Критерии включения

• 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 entire duration of the study. More than one opioid rotation has to be done before defining pain refractoriness.
• 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. Intolerance is defined as the occurrence of (S)AEs (even with dosage less than 200 mg/day of oral morphine equivalents) which prevents a further increase in the opioid dosage to obtain pain relief.
• Patients suitable for IDD and with the ability to comply with the medical protocol and visits.
• Survival prognosis of ≥ 6 months.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бельгия · 1 центр

• UZ Brussel — Jette

Идентификаторы

NCT: NCT07691840 · 2025-522381-68-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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