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

7 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

72

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Belgio
      • Jette, Belgio, 1090
        • Reclutamento
        • UZ Brussel
        • Contatto:
        • Sub-investigatore:
          • Ulrike Van Hoey, MSc
        • Sub-investigatore:
          • Britt Winnepenninckx, MSc
        • Sub-investigatore:
          • Lisa Goudman, MSc, PhD
        • Sub-investigatore:
          • Mark De Ridder, MD PhD
        • Investigatore principale:
          • Maarten Moens, MD PhD MBA

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Intrathecal Drug Delivery
Procedura: 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.
Comparatore attivo: Comprehensive Medical Management
Droga: Comprehensive Medical Management
Participants randomized to the CMM-group will receive standard care.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Health-related quality of life
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient comfort
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Universitair Ziekenhuis Brussel

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

31 ottobre 2029

Completamento dello studio (Stimato)

31 ottobre 2029

Date di iscrizione allo studio

Primo inviato

30 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

7 luglio 2026

Primo Inserito (Effettivo)

9 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 luglio 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2025-522381-68-00

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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