Back to resultsIV PCA With or Without Continuous Dose vs Oral Opioid to Maintain Analgesia for Severe Cancer Pain After Successful Titration
Primary Purpose
Cancer Pain
Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Hydromorphone Hydrochloride Injection
Hydromorphone Hydrochloride Injection
Morphine Sulfate Sustained-release Tablets
Sponsored by
About this trial
This is an interventional treatment trial for Cancer Pain focused on measuring Orally, IV PCA with continuous + bolus dose, IV PCA with bolus-only dose
Eligibility Criteria
Inclusion Criteria:
- The patients were 18-80 years old and diagnosed as malignant solid tumor by pathology;
- Patients with persistent cancer pain and NRS score ≥ 7 during previous 24 hours;
- Patients who did not receive radiotherapy, chemotherapy or targeted therapy within 7 days before randomization and trial；
- Patients or his/her caregivers who are able to fill out the questionnaire forms ;
- Ability to correctly understand and cooperate with medication guidance of doctors and nurses ;
- Without psychiatric problems;
- ECOG performance status ≤3;
- Patients who did not receive the trial drug within 14 days before the trial；
- The subjects voluntarily signed the informed consent.
Exclusion Criteria:
- The pain is confirmed not due to cancer;
- Patients with severe post-operative pain;
- Patients with paralytic ileus;
- Patients with brain metastasis;
- Patients hypersensitive to opioids;
- Patients with abnormal lab results that have obvious clinical significance, such as creatine ≥ 2 fold of upper limit of normal value, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 fold of upper limit of normal value, or liver function of Child C grade;
- Patients who cannot take drugs orally;
- Patients with an incoercible nausea or vomiting;
- Those who have received monoamine oxidase inhibitor (MAOI) within two weeks before randomization;
- Patients who are pregnant or in lactation, or who plan to be pregnant within one month after the trial;
- Alcoholic patients;
- Patients with other conditions or reasons causing the patients unable to complete the clinical trial.
Sites / Locations
- China, Fujian
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
PCA with continuous + bolus dose
PCA with bolus-only dose
Oral opioid
Arm Description
（1）Intravenous PCA with hydromorphone after successful titration of 24 hours;（2）PCA hydromorphone with continuous infusion where dose/h was the total equianalgesic over the previous 24h divided by 24 and bolus dosage for breakthrough pain was 10%-20% of the total equianalgesic over the previous 24h；lockout time = 10 minutes；（3）Evaluate every 24 hours and PCA parameters were adjusted according to the dose of the previous day; (4)The treatment regimen was continued for 7 days.
（1）Intravenous PCA with hydromorphone after successful titration of 24 hours; (2)PCA hydromorphone with bolus-only where dosage was 10%-20% of the total equianalgesic over the previous 24h administrated as needed;（3）Evaluate every 24 hours and PCA parameters were adjusted according to the dose of the previous day; (4)The treatment regimen was continued for 7 days.
（1）Swift to sustained-release morphine orally as background dose with immediate release morphine orally for breakthrough pain after successful titration of 24 hours；(2)Oral sustained-released morphine where total equianalgesic over the previous 24h/2×75% every 12h/day and immediate-release morphine for breakthrough pain was 10%-20% of the total equianalgesic over the previous 24h； (3)Evaluate every 24 hours and the dose for the next day is adjusted according to the dose of the previous day；(4)The treatment regimen was continued for 7 days.
Outcomes
Primary Outcome Measures
Mean pain score of days 1 to 3
The Numerical Rating Scale (NRS, a score of 0 means no pain and 10 means the most severe) is used to assess the severity of pain. NRS of 24 hours is assessed every day. Mean pain score is a sum of average NRS of Day 1 (D 1) to Day 3 divided by 3 (the day of titration is defined as D0, the first day after titration is defined as D1, the second day after titration is defined as D2, and so on).
Number of Breakthrough cancer Pain (BTcP)
Breakthrough cancer Pain (BTcP) is NRS > 3
Secondary Outcome Measures
Mean pain score of days 1 to 6
Mean pain score is a sum of average NRS of D1 to D6 divided by 6
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04785768
Brief Title
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
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2021 (Anticipated)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Pain
Keywords
Orally, IV PCA with continuous + bolus dose, IV PCA with bolus-only dose
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PCA with continuous + bolus dose
Arm Type
Experimental
Arm Description
（1）Intravenous PCA with hydromorphone after successful titration of 24 hours;（2）PCA hydromorphone with continuous infusion where dose/h was the total equianalgesic over the previous 24h divided by 24 and bolus dosage for breakthrough pain was 10%-20% of the total equianalgesic over the previous 24h；lockout time = 10 minutes；（3）Evaluate every 24 hours and PCA parameters were adjusted according to the dose of the previous day; (4)The treatment regimen was continued for 7 days.
Arm Title
PCA with bolus-only dose
Arm Type
Experimental
Arm Description
（1）Intravenous PCA with hydromorphone after successful titration of 24 hours; (2)PCA hydromorphone with bolus-only where dosage was 10%-20% of the total equianalgesic over the previous 24h administrated as needed;（3）Evaluate every 24 hours and PCA parameters were adjusted according to the dose of the previous day; (4)The treatment regimen was continued for 7 days.
Arm Title
Oral opioid
Arm Type
Active Comparator
Arm Description
（1）Swift to sustained-release morphine orally as background dose with immediate release morphine orally for breakthrough pain after successful titration of 24 hours；(2)Oral sustained-released morphine where total equianalgesic over the previous 24h/2×75% every 12h/day and immediate-release morphine for breakthrough pain was 10%-20% of the total equianalgesic over the previous 24h； (3)Evaluate every 24 hours and the dose for the next day is adjusted according to the dose of the previous day；(4)The treatment regimen was continued for 7 days.
Intervention Type
Drug
Intervention Name(s)
Hydromorphone Hydrochloride Injection
Intervention Description
Intravenous PCA with hydromorphone after successful titration of 24 hours.the PCA setting: 1) continuous dose (dose/hours) = the total dosage of hydromorphone in the previous 24 hours/24; 2) bolus dose = 10-20% of the total dosage of hydromorphone in the previous 24 hours; 3) lockout time = 10 minutes; 4）Evaluate every 24 hours and PCA parameters were adjusted according to the dose of the previous day.
Intervention Type
Drug
Intervention Name(s)
Hydromorphone Hydrochloride Injection
Intervention Description
Intravenous PCA with hydromorphone after successful titration of 24 hours.the PCA setting: 1) continuous dose = 0; 2) bolus dose = 10-20% of the total dosage of hydromorphone in the previous 24 hours: 3) lockout time = 10 minutes; 4)Evaluate every 24 hours and PCA parameters were adjusted according to the dose of the previous day.
Intervention Type
Drug
Intervention Name(s)
Morphine Sulfate Sustained-release Tablets
Intervention Description
Swift to sustained-release morphine orally as background dose with immediate release morphine orally for breakthrough pain after successful titration of 24 hours.
Administration of morphine orally 1) Sustained-release morphine orally (dose/12 hours) = the total equianalgesic of the previous 24 hours/2×75% for day 1; 2）the total equianalgesic of the previous 24 hours/2 for day 2 ; 3）Evaluate every 24 hours and the dose for the next day is adjusted according to the dose of the previous day；4) Immediate release morphine orally = 10-20% of the total equianalgesic of the previous 24 hours;
Primary Outcome Measure Information:
Title
Mean pain score of days 1 to 3
Description
The Numerical Rating Scale (NRS, a score of 0 means no pain and 10 means the most severe) is used to assess the severity of pain. NRS of 24 hours is assessed every day. Mean pain score is a sum of average NRS of Day 1 (D 1) to Day 3 divided by 3 (the day of titration is defined as D0, the first day after titration is defined as D1, the second day after titration is defined as D2, and so on).
Time Frame
up to 4 days
Title
Number of Breakthrough cancer Pain (BTcP)
Description
Breakthrough cancer Pain (BTcP) is NRS > 3
Time Frame
up to 4 days
Secondary Outcome Measure Information:
Title
Mean pain score of days 1 to 6
Description
Mean pain score is a sum of average NRS of D1 to D6 divided by 6
Time Frame
up to 7 days
Other Pre-specified Outcome Measures:
Title
Number of patients with an average NRS pain score >3
Description
The Numerical Rating Scale (NRS, a score of 0 means no pain and 10 means the most severe) is used to assess the severity of pain.
Time Frame
up to 7 days
Title
Number of patients with an average NRS pain score > 6
Description
The Numerical Rating Scale (NRS, a score of 0 means no pain and 10 means the most severe) is used to assess the severity of pain.
Time Frame
up to 7 days
Title
Daily opioid dosage
Description
Daily opioid dosage
Time Frame
up to 7 days
Title
Satisfaction score
Description
The satisfaction score of the patients to analgesia was evaluated by 10-point scale: 0 points for dissatisfaction, 10 points for very satisfied, the higher the score, the higher the satisfaction.
Time Frame
up to 7 days
Title
Quality of life of patients
Description
Chinese version of the Edmonton Symptom Assessment System.
Time Frame
up to 7 days
Title
Number of patients who switched/discontinued therapy due to serious adverse events or lack of pain control
Description
The number of patients who switched/discontinued therapy due to serious adverse events or lack of pain control
Time Frame
up to 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patients were 18-80 years old and diagnosed as malignant solid tumor by pathology;
Patients with persistent cancer pain and NRS score ≥ 7 during previous 24 hours;
Patients who did not receive radiotherapy, chemotherapy or targeted therapy within 7 days before randomization and trial；
Patients or his/her caregivers who are able to fill out the questionnaire forms ;
Ability to correctly understand and cooperate with medication guidance of doctors and nurses ;
Without psychiatric problems;
ECOG performance status ≤3;
Patients who did not receive the trial drug within 14 days before the trial；
The subjects voluntarily signed the informed consent.
Exclusion Criteria:
The pain is confirmed not due to cancer;
Patients with severe post-operative pain;
Patients with paralytic ileus;
Patients with brain metastasis;
Patients hypersensitive to opioids;
Patients with abnormal lab results that have obvious clinical significance, such as creatine ≥ 2 fold of upper limit of normal value, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 fold of upper limit of normal value, or liver function of Child C grade;
Patients who cannot take drugs orally;
Patients with an incoercible nausea or vomiting;
Those who have received monoamine oxidase inhibitor (MAOI) within two weeks before randomization;
Patients who are pregnant or in lactation, or who plan to be pregnant within one month after the trial;
Alcoholic patients;
Patients with other conditions or reasons causing the patients unable to complete the clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rongbo Lin, MD
Phone
86+13705919382
Email
rongbo_lin@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rong bo Lin, MD
Organizational Affiliation
Fujian Cancer Hospital,Department of Gastrointestinal Medical Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
China, Fujian
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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IV PCA With or Without Continuous Dose vs Oral Opioid to Maintain Analgesia for Severe Cancer Pain After Successful Titration
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