Intrathecal Therapy Versus Standard Care for Severe Cancer Pain

Universitair Ziekenhuis Brussel72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Intrathecal Drug Delivery Refractory Cancer Pain Conventional Medical Management

Interventions

Intrathecal Drug DeliveryPROCEDURE

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 following surgery, dose titration will be performed to establish the optimal balance between pain relief and tolerability. Following implantation, the most common postoperative procedure is the drug refill. This involves aseptic access to the pump reservoir, removal of any residual volume, and replenishment with a fresh dose of medication. Refill intervals will depend on the patient's daily dosage, ranging from monthly to once every 2-3 months.

Comprehensive Medical ManagementDRUG

Participants randomized to the CMM-group will receive standard care.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion 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 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. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

Health-related quality of life

Health-related quality of life will be evaluated with the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).

Time frame: At baseline and 1, 2, 4, 6, 8, 10, and 12 months post-treatment initiation

Secondary Outcomes

Patient comfort

Patient comfort is evaluated with the General Comfort Questionnaire (GCQ), a self-reported instrument consisting of 48 items that reflect the physical, spiritual, environmental, and social dimension.