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Intrathecal Therapy Versus Standard Care for Severe Cancer Pain (CAREGIVER)

7. juli 2026 opdateret af: Moens Maarten, Universitair Ziekenhuis Brussel

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

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

72

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Belgien
      • Jette, Belgien, 1090
        • Rekruttering
        • UZ Brussel
        • Kontakt:
        • Underforsker:
          • Ulrike Van Hoey, MSc
        • Underforsker:
          • Britt Winnepenninckx, MSc
        • Underforsker:
          • Lisa Goudman, MSc, PhD
        • Underforsker:
          • Mark De Ridder, MD PhD
        • Ledende efterforsker:
          • Maarten Moens, MD PhD MBA

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Intrathecal Drug Delivery
Procedure: 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 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.
Aktiv komparator: Comprehensive Medical Management
Medicin: Comprehensive Medical Management
Participants randomized to the CMM-group will receive standard care.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Health-related quality of life
Tidsramme: At baseline and 1, 2, 4, 6, 8, 10, and 12 months post-treatment initiation
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient comfort
Tidsramme: At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation
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.
At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation
Survival
Tidsramme: At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation
The survival rate will be determined by recording the time from treatment initiation until death.
At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation
Pain intensity
Tidsramme: At baseline and 1, 2, 4, 6, 8, 10, and 12 months post-treatment initiation
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.
At baseline and 1, 2, 4, 6, 8, 10, and 12 months post-treatment initiation
Perceived stress
Tidsramme: At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation
Perceived stress will be assessed by using the 10-item Perceived Stress Scale.
At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation
Anxiety
Tidsramme: At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation
Patient anxiety will be provided through the State Trait Anxiety Inventory (STAI).
At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation
Perceived Injustice
Tidsramme: At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation
Using the Injustice Experience Questionnaire (IEQ), perceived injustice related to current health status will be assessed.
At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation
Self-efficacy
Tidsramme: At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation
The General Self-Efficacy (GSE) Scale is a 10-item self-report questionnaire used to assess perceived self-efficacy.
At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation
Caregiver burden
Tidsramme: At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation
To evaluate caregiver burden, the Zarit Burden Interview (ZBI) questionnaire will be completed. This 12-item self-report instrument assesses caregiver burden and is a shortened version of the original 22-item Zarit Burden Scale.
At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation
Health expenditure
Tidsramme: monthly after treatment initiation until 12 months
Expenditures related to in-hospital care will be extracted from hospital claims data. All other healthcare-related costs will be gathered through telephone interviews with patients, conducted each month after treatment initiation. During these calls, researchers will ask patients whether they have had any medical consultations, hospital admissions, AEs, changes in medication (such as daily morphine, MED, antidepressants,…), or incurred any additional healthcare costs.
monthly after treatment initiation until 12 months
Safety
Tidsramme: Throughout the duration of the study, an average of 12 months.
Recording of (serious) adverse events.
Throughout the duration of the study, an average of 12 months.
Number of responders
Tidsramme: at 1, 2, 4, 6, and 12 months post-treatment initiation
Responder status will be determined based on pain scores, adverse events, and medication dose changes. Responders are defined as patients achieving a clinically meaningful reduction in pain intensity (≥30% from baseline) without intolerable adverse effects.
at 1, 2, 4, 6, and 12 months post-treatment initiation

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universitair Ziekenhuis Brussel

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

31. oktober 2029

Studieafslutning (Anslået)

31. oktober 2029

Datoer for studieregistrering

Først indsendt

30. juni 2026

Først indsendt, der opfyldte QC-kriterier

7. juli 2026

Først opslået (Faktiske)

9. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2025-522381-68-00

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