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

7. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

72

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Belgien
      • Jette, Belgien, 1090
        • Rekrutierung
        • UZ Brussel
        • Kontakt:
        • Unterermittler:
          • Ulrike Van Hoey, MSc
        • Unterermittler:
          • Britt Winnepenninckx, MSc
        • Unterermittler:
          • Lisa Goudman, MSc, PhD
        • Unterermittler:
          • Mark De Ridder, MD PhD
        • Hauptermittler:
          • Maarten Moens, MD PhD MBA

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Intrathecal Drug Delivery
Verfahren: 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.
Aktiver Komparator: Comprehensive Medical Management
Arzneimittel: Comprehensive Medical Management
Participants randomized to the CMM-group will receive standard care.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Health-related quality of life
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Patient comfort
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Universitair Ziekenhuis Brussel

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

31. Oktober 2029

Studienabschluss (Geschätzt)

31. Oktober 2029

Studienanmeldedaten

Zuerst eingereicht

30. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Juli 2026

Zuerst gepostet (Tatsächlich)

9. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. Juli 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2025-522381-68-00

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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