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Effectiveness and safety of methadone 3-day switching method for pain control in patients who reached high doses of opioids

Effectiveness and safety of methadone 3-day switching method for pain control in patients who reached high doses of opioids

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079719
Enrollment
Unknown
Registered
2024-01-10
Start date
2020-02-27
Completion date
Unknown
Last updated
2024-01-14

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

Conditions

Cancer pain

Interventions

methadone conversion:The patients with refractory cancer pain who have already reached high doses of opioids switching from other opioids to methadone using the 3DS method.

Sponsors

Zhejiang Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) age 18-75 years old; 2) diagnosis of refractory cancer pain; 3) hospitalized patients; 4) male or female; 5) expected survival period of more than 2 months; 6) clear consciousness, no intellectual and mental impairment, normal language expression ability, Karnofsky performance score (KPS score) =50 points; 7) agreement to participate and a signed informed consent form.; 8) High-dose opioids used (greater than or equal to 300 mg/day of oral morphine(oral morphine equivalents, OME)) with poor pain control as NRS = 4 points or BTP= 3 times/day, or side-effects caused by opioids cannot be tolerated.

Exclusion criteria

Exclusion criteria: 1) cannot take drugs orally, such as intestinal obstruction, gastric retention, inability to swallow; 2) develop pain related to tumor emergencies, such as pathological fractures; 3) have mental illness or severe cognitive impairment; 4) are pregnant or lactating women; 5) have respiratory depression; 6) have a history of organic heart disease or arrhythmia; 7) have diagnosis of the active cerebrovascular disease; 8) are taking strong CYP3A4 inhibitors such as macrolide antibiotics, ketoconazole, itraconazole, voriconazole, and indinavir; 9) have a longer than 450 ms of QTc interval on the baseline electrocardiogram.

Design outcomes

Primary

MeasureTime frame
Conversion success rate;Time to pain relief;

Secondary

MeasureTime frame
Pain intensity;Breakthrough pain;methadone daily dose ;actual methadone conversion ratio;QTc interval ;Assessment of symptoms;

Countries

China

Contacts

Public ContactLiyan Gong

Zhejiang Cancer Hospital

1413472557@qq.com+86 138 5806 5155

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026