Intrathecal Therapy Versus Standard Care for Severe Cancer Pain

NCT07691840 | Recruiting

• 1 other identifier: 2025-522381-68-00
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Refractory Cancer Pain; Intrathecal Drug Delivery; Conventional Medical Management

Keywords

Intrathecal pumps; Intrathecal drug delivery; Refractory cancer pain; Health-related quality of life; Neuromodulation

Outcome Measures

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).

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

Secondary Outcomes (11)

• Patient comfort

  At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation

• Survival

  At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation

• Pain intensity

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

• Perceived stress

  At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation

• Anxiety

  At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation

Study Arms (2)

Intrathecal Drug Delivery

ACTIVE COMPARATOR

Procedure: Intrathecal Drug Delivery

Comprehensive Medical Management

ACTIVE COMPARATOR

Drug: Comprehensive Medical Management

Interventions

Intrathecal Drug Delivery PROCEDURE

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.

Intrathecal Drug Delivery

Comprehensive Medical Management DRUG

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

Comprehensive Medical Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify 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).
• 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.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Jette, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Maarten Moens, MD PhD MBA

CONTACT

+3224775514; stimulusresearchgroup@gmail.com

Lisa Goudman, MSC, PhD

CONTACT

+32472412507; lisa.goudman@vub.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 9, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): October 31, 2029
• Study Completion (Estimated): October 31, 2029
• Last Updated: July 9, 2026

Record last verified: 2026-06

Locations

BE (1)