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Safety and Efficacy of Low-Dose Methadone as an Adjunctive Therapy with Other Opioids for Cancer-Related Pain

Safety and Efficacy of Low-Dose Methadone as an Adjunctive Therapy with Other Opioids for Cancer-Related Pain - Low-Dose Methadone as an Adjunctive Therapy with Other Opioids for Cancer-Related Pain

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112381
Enrollment
Unknown
Registered
2025-11-13
Start date
2025-09-16
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Pain related to malignancy

Interventions

Intervention Group:Upon hospitalization, patients underwent pain titration using a hydromorphone PCIA pump. The pump parameters were set based on 120% of the prior 24-hour opioid consumption and were
Control Group:Upon hospitalization, pain management was initiated with a hydromorphone Patient-Controlled Intravenous Analgesia (PCIA) pump. The pump parameters were set at 1.2 times the previous 24-h

Sponsors

Jiangsu Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or older, regardless of gender. 2. Diagnosed with a malignant tumor according to UICC (Union for International Cancer Control) criteria, confirmed by pathology and/or cytology, or by imaging in combination with specific tumor markers. 3. Presence of cancer-related pain with a Numeric Rating Scale (NRS) score of >= 4. 4. No severe cognitive impairment, and able to cooperate with the treatment and investigation. 5. Voluntary participation in this study, having provided signed informed consent, with good compliance and willingness to cooperate with follow-up.

Exclusion criteria

Exclusion criteria: 1. Known allergy or hypersensitivity to methadone or other opioids. 2. Patients whose pain could be alleviated by surgical intervention. 3. Patients with organic heart disease or a QTc interval > 500 ms. 4. Patients with absolute contraindications to opioids, such as: paralytic ileus, bronchial asthma, intracranial hypertension, decompensated cor pulmonale, respiratory depression, etc. 5. Presence of non-cancer-related pain (including psychogenic pain) or pain of unknown etiology. 6. History of psychiatric disorders or presence of severe cognitive impairment. 7. Pregnant or lactating women. 8. Concurrent use of monoamine oxidase inhibitors (MAOIs). 9. Presence of active cerebrovascular disease. 10. Patients with moderate to severe hepatic or renal impairment, defined as: serum creatinine >= 2 times the upper limit of normal (ULN); OR ALT/AST >= 2.5 times ULN (may be extended to >= 5 times ULN for patients with liver metastases); OR Child-Pugh Class C liver function. 11. Patients with any other concomitant illness deemed by the investigator to pose a serious risk to patient safety or to compromise the completion of the study. 12. Concurrent participation in any other clinical trial that may interfere with the outcome assessment of this study.

Design outcomes

Primary

MeasureTime frame
Pain Response Rate;

Secondary

MeasureTime frame
Pain stabilization time;Daily NRS rating;Number of painful outbursts;quality of life;

Countries

China

Contacts

Public ContactYang Yang

Jiangsu Cancer Hospital

www.675436693@qq.com+86 192 9173 1952

Outcome results

None listed

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