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A randomized clinical trial of hydromorphone and fentanyl in continuous subcutaneous titration for severe cancer pain

A randomized clinical trial of hydromorphone and fentanyl in continuous subcutaneous titration for severe cancer pain - RCT of hydromorphone and fentanyl in continuous subcutaneous titration

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1051220045
Enrollment
100
Registered
2022-06-10
Start date
2022-06-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe cancer pain Severe cancer pain

Interventions

Continuous subcutaneous titration of opioids is performed. Methods: A 24 G plastic cannula is inserted subcutaneously in the abdomen
continuous subcutaneous administration is performed using a small syringe pump for 10 mL syringes. For pioid naive patients, opioids are infected by flow rates
(1) hydromorphone dissolved at 0.2 mg/mL, starting at 0.20 mL/h and increasing by 0.05 ml/h up to 1.0 ml/h. If the situation requires further increase of hydromorphone, replace with hydromorphone 1.0
Continuous subcutaneous injection
titration of opioids

Sponsors

Kajiyama Toru
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with severe cancer pain (numerial rating scale 7-10) who desired continuous subcutaneous titration with opioid analgesics.

Exclusion criteria

Exclusion criteria: Impaired consciousness, delirium, cognitive impairment, renal impairment, hepatic impairment, poor general condition assessment, gastrointestinal transit disorder, patients under 20 years of age, drug allergy to the study drug, and patients who did not consent to participate in the study.

Design outcomes

Primary

MeasureTime frame
At least 66% pain reduction of numerical ration scale within 3 days

Secondary

MeasureTime frame
Titration completion rate within 7 days; Titration completion days (days from start to end of continuous subcutaneous administration); Pain intensity at day 7 / Dyspnea / Sleep assessment / Quality of life assessment / Rescue medication use assessment / Adverse events.

Contacts

Public ContactTatsuma Sakaguchi

Kitano Hospital, Tazuke Kofukai Medical Research Institute

sakaguchi.tatsuma@gmail.com+81-6-6312-1221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026