Clinical trial NCT04785768: IV PCA With or Without Continuous Dose vs Oral Opioid to Maintain Analgesia for Severe Cancer Pain After Successful Titration
Official title: Intravenous (IV) Patient Controlled Analgesia (PCA) With or Without Continuous Dose vs Oral Opioid to Maintain Analgesia for Severe Cancer Pain After Successful Hydromorphone Titration: a Multi-center, Phase Ⅲ ，Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer Pain
Keywords: Orally
IV PCA with continuous + bolus dose
IV PCA with bolus-only dose
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2021-03-08
Enrollment: 1372
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 explore the difference of efficacy and safety between PCA with continuous + bolus dose versus bolus-only.


Eligibility criteria: Inclusion Criteria

1. Age 18 to 80 years;
2. Histologically or cytologically confirmed malignant solid tumor;
3. 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;
4. No radiotherapy to the painful area prior to randomization;
5. No radiotherapy, chemotherapy, hormone therapy, targeted therapy, or bisphosphonate therapy within 7 days before randomization;
6. Successful IPCA-HM titration within the past 24 hours;
7. No history of psychiatric disorders;
8. Ability to complete questionnaires;
9. Ability to correctly understand and follow medication guidance from doctors and nurses;
10. ECOG performance status ≤ 3;
11. 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.

Primary outcomes:
measure: 3DNRS (3-day average Numeric Rating Scale)
timeFrame: up to 4 days
Secondary outcomes:
measure: Daily avNRS score of days 1 to 6
timeFrame: up to 7 days
measure: Adverse events
timeFrame: up to 8 days
measure: Improvement in physical symptoms and overall well-being
timeFrame: up to 7 days
measure: Patient Satisfaction Score
timeFrame: up to 7 days
measure: Daily equivalent morphine consumption
timeFrame: up to 7 days
measure: Number of patients with an average NRS pain score > 6
timeFrame: up to 7 days
measure: Number of patients with an average NRS pain score >3
timeFrame: up to 7 days
measure: Patient Satisfaction Score
timeFrame: up to 7 days
measure: Maximum NRS (Days 1 to 6)
timeFrame: up to 7 days
measure: Daily frequency and duration of breakthrough cancer pain
timeFrame: up to 7 days
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: China, Fujian
state: Fujian
Study officials:
affiliation: Fujian Cancer Hospital,Department of Gastrointestinal Medical Oncology
name: Rong bo Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: