Status:
COMPLETED
IV PCA With or Without Continuous Dose vs Oral Opioid to Maintain Analgesia for Severe Cancer Pain After Successful Titration
Lead Sponsor:
Fujian Cancer Hospital
Conditions:
Cancer Pain
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Based on the previous HMORCT09-2, the results show that IV PCA for analgesia maintenance improvements control of severe cancer pain after successful titration. Therefore, a study is planned to further...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Age 18 to 80 years;
- Histologically or cytologically confirmed malignant solid tumor;
- Persistent severe cancer-related pain (≥7 at rest on the 11-point numeric rating scale \[NRS\], where 0=no pain and 10=excruciating pain) in the 24 hours before screening;
- No radiotherapy to the painful area prior to randomization;
- No radiotherapy, chemotherapy, hormone therapy, targeted therapy, or bisphosphonate therapy within 7 days before randomization;
- Successful IPCA-HM titration within the past 24 hours;
- No history of psychiatric disorders;
- Ability to complete questionnaires;
- Ability to correctly understand and follow medication guidance from doctors and nurses;
- ECOG performance status ≤ 3;
- Provided written informed consent. Exclusion Criteria
- 1\) Patients with non-cancer-related pain; 2) Patients with paralytic ileus; 3) Patients with brain metastases; 4) Patients with hypersensitivity to morphine or hydromorphone; 5) Abnormal laboratory results: creatinine ≥ 2-fold of upper limit of normal (ULN) value, Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) ≥ 2.5-fold of the ULN value (≥ 5-fold for subjects with liver metastasis or primary liver cancer), or Child-Pugh class C liver function; 6) Patients unable to take oral medication; 7) Patients with uncontrolled nausea or vomiting; 8) Prior use of hydromorphone, morphine, or PCA devices within 14 days before screening; 9) Use of monoamine oxidase inhibitor drugs (MAOID) within the two weeks before randomization; 10) Women who are pregnant, lactating, or planning to be pregnant within one month after the trial completion; 11) Patients who abuse alcohol; 12) Patients with any other medical condition or reason, in the investigator's judgment, that would make them unsuitable to participate in the clinical trial.
Exclusion
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2024
Estimated Enrollment :
1372 Patients enrolled
Trial Details
Trial ID
NCT04785768
Start Date
July 1 2021
End Date
July 1 2024
Last Update
May 22 2025
Active Locations (1)
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1
China, Fujian
Fuzhou, Fujian, China, 350014