Morphine hydrochloride for Severe refractory cancer pain

Inclusion criteria

• {"criterion_text":"- 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.\n- 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.\n- Patients suitable for IDD and with the ability to comply with the medical protocol and visits.\n- Survival prognosis of ≥ 3 months."}

Exclusion criteria

• {"criterion_text":"- Patients with active, severe infection.\n- Patients with known brain metastases.\n- Patients with high risk of hemorrhaging.\n- Patients with allergies for medication or IDD hardware.\n- Pregnant or lactating women.\n- Women who plan to become pregnant within 1 month after the study."}

Primary endpoints

• {"endpoint_text":"- HRQoL will be evaluated with the EORTC QLQ-C30 questionnaire.","definition_or_measurement_approach":"Health-related quality of life measured using the EORTC QLQ-C30 questionnaire."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Patient comfort measured using the 48-item General Comfort Questionnaire (GCQ)."}
• {"endpoint_text":"- The survival rate in both groups, CMM and IDD, will be determined by recording the time from treatment initiation until death.","definition_or_measurement_approach":"Survival measured as time from treatment initiation to death (time-to-event)."}
• {"endpoint_text":"- Pain intensity will be measured with the VAS (ranging from 0 (no pain) to 100 (maximal pain)) in electronic format.","definition_or_measurement_approach":"Pain intensity assessed electronically via Visual Analogue Scale (0–100 mm)."}
• {"endpoint_text":"- Perceived stress will be assessed by using the 10-item Perceived Stress Scale (PSS; Cohen, Kamarch, & Mermelstein, 1983).","definition_or_measurement_approach":"Perceived stress measured using the 10-item Perceived Stress Scale (PSS)."}
• {"endpoint_text":"- Patient anxiety will be provided through the State Trait Anxiety Inventory (STAI).","definition_or_measurement_approach":"Anxiety measured using the State-Trait Anxiety Inventory (STAI)."}
• {"endpoint_text":"- Using the Injustice Experience Questionnaire (IEQ), perceived injustice related to current health status will be assessed.","definition_or_measurement_approach":"Perceived injustice measured using the Injustice Experience Questionnaire (IEQ)."}
• {"endpoint_text":"- The General Self-Efficacy (GSE) Scale is a 10-item self-report questionnaire used to assess perceived self-efficacy.","definition_or_measurement_approach":"Self-efficacy measured using the 10-item General Self-Efficacy (GSE) Scale."}
• {"endpoint_text":"- To evaluate caregiver burden, the Zarit Burden Interview (ZBI) questionnaire will be completed.","definition_or_measurement_approach":"Caregiver burden measured using the Zarit Burden Interview (ZBI) questionnaire."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Health expenditure measured via hospital claims data for in-hospital costs and monthly telephone interviews for other healthcare costs and resource use."}
• {"endpoint_text":"- Safety, all (S)AEs will be documented throughout the duration of the study.","definition_or_measurement_approach":"Safety assessed by recording all adverse events (AEs) and serious adverse events (SAEs) during study."}

Methods

• K1_Recruitment arrangements document available (document: K1_Recruitment arrangements).
• Recruitment materials included: recruitment videos (Dutch and French) and recruitment flyers (Dutch and French) (K2 recruitment materials).
• Site-based recruitment at participating hospital (UZ Brussel) with local PI contact (email/telephone provided in site record).

Belgium

Earliest CTIS Part Ii Submission Date

11-02-2026

Latest Decision Or Authorization Date

23-04-2026

Processing Time Days

71

Number Of Sites

1

Number Of Participants

72

Primary sponsor

Full Name

Vrije Universiteit Brussel

Organisation Type

Educational Institution

Country Of Registered Address

Belgium