Subcutaneous verus intravenous morphine in palliative cancer patients

Phase 1

• Conditions: Cancer pain not responding to oral opioids in palliative cancer patient, where switching to the parenteral route is indicated.; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2021-003427-14-NO
• Lead Sponsor: Akershus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-01
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

All of the following conditions must apply to the prospective patient at screening prior to receiving study agent:
•Unsatisfactory pain control despite titration of oral or transdermal opioids
•Planned discharge to home or nursing home
•The physician considers the appropriate starting dose to be either morphine 5 mg/ml with infusion rate 0.3 to 0.8 ml/h or morphine 10 mg/ml with infusion rate 0.3 to 0.8 ml/h.
•Signed informed consent from the patient
•Patient available for admission to Department of Palliative Medicine in time to start infusion between 9 am and 1 pm (Monday-Wednesday

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

•A clear indication for either intravenous or subcutaneous administration (by consensus of two senior consultants in palliative medicine)
•Patient unable to report patient reported outcomes needed in the study due to language barriers, cognitive impairment, or delirium.
•Impossible to establish venous access
•Allergy or previous serious adverse effects from morphine
•Opioid treatments other than oral/parenteral morphine, oral/parenteral oxycodone and transdermal/transmucosal fentanyl.
•Contraindications to use of morphine.
- Severe renal failure (estimated glomerular filtration rate < 30 based on kreatinin)
•Strong indication for start of morphine infusion outside of the time interval of 9 am to 1 pm Monday to Wednesday.
•Estimated survival time <2 weeks based on clinical judgement (by consensus of two senior consultants in palliative medicine)
•Severe cachecia or peripheral edemas which are relative contraindications to the subcutaneous route of administration (clinical judgement by the responsible physician)

Patients with Hb <9 g/dL (7.0 – 9.9 g/dL is considered moderate anemia) will not be included in the pharmacokinetic analyses because it can not be ruled out that the loss of 100-150 ml blood might be harmful in some of these patients.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified