Comparing a pain pump and standard pain medication for severe cancer pain

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Vrije Universiteit Brussel

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Decision date (initial)

2026-03-04

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

Health related quality of life

Secondary objectives 10

1. Comfort
2. Survival
3. Pain intensity
4. Perceived stress
5. Anxiety
6. Perceived injustice
7. Self-efficacy
8. Burden caregivers
9. Health expenditure
10. Safety

Conditions and MedDRA coding

Severe refractory cancer pain

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Adult patients (≥18 years) with severe cancer refractory pain (all types of cancer), who have been receiving treatment with 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.
2. 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 inten-sity score at rest of ≥ 50 mm. Intolerance is defined as the occurrence of (severe) adverse events (AE) (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.
3. Patients suitable for IDD and with the ability to comply with the medical protocol and visits.
4. Survival prognosis of ≥ 3 months.

Exclusion criteria 6

1. Patients with active, severe infection.
2. Patients with known brain metastases.
3. Patients with high risk of hemorrhaging.
4. Patients with allergies for medication or IDD hardware.
5. Pregnant or lactating women.
6. Women who plan to become pregnant within 1 month after the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. HRQoL will be evaluated with the EORTC QLQ-C30 questionnaire.

Secondary endpoints 10

1. 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.
2. The survival rate in both groups, CMM and IDD, will be determined by recording the time from treatment initiation until death.
3. Pain intensity will be measured with the VAS (ranging from 0 (no pain) to 100 (maximal pain)) in electronic format.
4. Perceived stress will be assessed by using the 10-item Perceived Stress Scale (PSS; Cohen, Kamarch, & Mermelstein, 1983).
5. Patient anxiety will be provided through the State Trait Anxiety Inventory (STAI).
6. Using the Injustice Experience Questionnaire (IEQ), perceived injustice related to current health status will be assessed.
7. The General Self-Efficacy (GSE) Scale is a 10-item self-report questionnaire used to assess perceived self-efficacy.
8. To evaluate caregiver burden, the Zarit Burden Interview (ZBI) questionnaire will be completed.
9. 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 (daily morphine or MED), or incurred any additional healthcare costs.
10. Safety, all (S)AEs will be documented throughout the duration of the study.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Vrije Universiteit Brussel

Sponsor organisation

Vrije Universiteit Brussel

Address

Laarbeeklaan 103

City

Jette

Postcode

1090

Country

Belgium

Scientific contact point

Organisation

Vrije Universiteit Brussel

Contact name

PI

Public contact point

Organisation

Vrije Universiteit Brussel

Contact name

Caregiver PhD students

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 61 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications