Intrathecal Therapy Versus Standard Care for Severe Cancer Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitair Ziekenhuis Brussel
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients with active, severe infection.
Patients with known brain metastases.
Patients with high risk of hemorrhaging.
Patients with respiratory depression (for use of morphine).
Trial design
Design model
Parallel
Treatments tested in this trial
Intrathecal Drug Delivery
Procedure/SurgeryPatients 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 Management
DrugParticipants randomized to the CMM-group will receive standard care.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Intrathecal Drug DeliveryActive comparator 1 intervention
Group B: Comprehensive Medical ManagementActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 initiationSecondary outcomes
1
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.
Time frame
At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation2
Survival
The survival rate will be determined by recording the time from treatment initiation until death.
Time frame
At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation3
Pain intensity
Pain intensity will be measured with the Visual Analogue Scale (ranging from 0 (no pain) to 100 (maximal pain)) in electronic format. Momentary data collection will be used to collect pain intensity scores for VAS (valid and reliable for pain experience), whereby pain intensity is measured for multiple times per day for 1 week to reveal patterns of transient or fluctuating symptoms in the environment and context of the patients' lives, without a recall bias.
Time frame
At baseline and 1, 2, 4, 6, 8, 10, and 12 months post-treatment initiation4
Perceived stress
Perceived stress will be assessed by using the 10-item Perceived Stress Scale.
Time frame
At baseline and 1, 2, 4, 6, and 12 months post-treatment initiationSponsors and contacts
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Source ClinicalTrials.gov