Back to resultsIntravenous vs Oral Analgesia in Cancer Patients With Severe Pain After Successful Titration
Primary Purpose
Cancer Pain
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
PCA IV Hydromorphone (continuous dose = 0)
PCA IV Hydromorphone (continuous dose ≠ 0)
Oral morphine
Sponsored by
About this trial
This is an interventional treatment trial for Cancer Pain focused on measuring Orally, PCA intravenously, Analgesia, Severe cancer pain
Eligibility Criteria
Inclusion Criteria:
- The patients were 18-80 years old and diagnosed as malignant tumor by pathology;
- Patients with cancer pain is NRS pain score ≥ 7 during previous 24 hours;
- Patients who will not be treated with radiotherapy within 7 days prior to randomization and during study ;
- Patients who need chemotherapy, long term administration of hormone, targeted therapy, or bisphosphonates therapy should undergo a stable anti- tumor therapy prior to randomization ;
- 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;
- Not participated in another drug clinical trial within one month before inclusion（including hydromorphone）;
- 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;
- Those with opioid addiction;
- Alcoholic patients;
- Those with cognitive dysfunction;
- Those with severe depression;
- 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 IV Hydromorphone (continuous dose = 0)
PCA IV Hydromorphone (continuous dose ≠ 0)
Oral Morphine
Arm 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 once every 24 hours
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 once every 24 hours
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 d1; the total equianalgesic of the previous 24 hours/2 for day 2 and day 3; 2) Immediate release morphine orally = 10-20% of the total equianalgesic of the previous 24 hours; 3) Evaluate once every 24 hours
Outcomes
Primary Outcome Measures
Mean pain score
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. The mean pain score is a sum of NRS of day 1 (the day after successful titration of 24 hours) to day 3 divided by 3.
If the NRS of the morphine orally group >3, the NRS in the hydromorphone PCA intravenously group declines more than 30% compared to morphine orally group, which is regards a positive result.
Number of Breakthrough cancer Pain (BTcP) episodes
If NRS of the morphine orally group pain score ≤3 , or if NRS in the hydromorphone PCA intravenously group declines less than 30% compared to morphine orally group, number of Breakthrough cancer Pain (BTcP) episodes in the one of both the hydromorphone PCA intravenously group declines less than 30% compared to morphine orally group, which is regards a positive result.
Secondary Outcome Measures
Number of patients with an average NRS pain score> 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.
Number of patients with an average NRS pain score> 6
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.
Total dosage of opioids
The total dosage of opioids in day 1 to day 3 (day 1 is the day after successful titration of 24 hours)
Satisfaction score
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.
Quality of life of patients
Chinese version of the Edmonton Symptom Assessment System.
Number of patients who switched/discontinued therapy due to serious adverse events or lack of pain control
The number of patients who switched/discontinued therapy due to serious adverse events or lack of pain control
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04243954
Brief Title
Intravenous vs Oral Analgesia in Cancer Patients With Severe Pain After Successful Titration
Official Title
Hydromorphone PCA Intravenously vs Sustained-Release Morphine Orally in Cancer Patients With Severe Pain After Successful Titration: A Multicenter, Randomized, Controlled, Phase II Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 10, 2020 (Actual)
Primary Completion Date
October 21, 2020 (Actual)
Study Completion Date
November 21, 2020 (Actual)
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
Pain is one of the most common and fear symptoms for cancer patients, which seriously affects the quality of life in cancer patients. At present, oral opioid is the most common route to administrate cancer pain. However, the patients do not satisfy the pain administration with oral opioid after successful titration in many cases, especially the cases with severe cancer pain. Patient controlled analgesia (PCA) with hydromorphone can take analgesic effect rapidly. The aim of this trial is to compare the maintenance with hydromorphone PCA intravenously or switch to Sustained-Release Morphine orally after successful titraton with hydromorphone PCA intravenously in severe cancer pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Pain
Keywords
Orally, PCA intravenously, Analgesia, Severe cancer pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
95 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PCA IV Hydromorphone (continuous dose = 0)
Arm Type
Experimental
Arm 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 once every 24 hours
Arm Title
PCA IV Hydromorphone (continuous dose ≠ 0)
Arm Type
Experimental
Arm 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 once every 24 hours
Arm Title
Oral Morphine
Arm Type
Active Comparator
Arm 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 d1; the total equianalgesic of the previous 24 hours/2 for day 2 and day 3; 2) Immediate release morphine orally = 10-20% of the total equianalgesic of the previous 24 hours; 3) Evaluate once every 24 hours
Intervention Type
Drug
Intervention Name(s)
PCA IV Hydromorphone (continuous dose = 0)
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 once every 24 hours
Intervention Type
Drug
Intervention Name(s)
PCA IV Hydromorphone (continuous dose ≠ 0)
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 once every 24 hours
Intervention Type
Drug
Intervention Name(s)
Oral morphine
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 d1; the total equianalgesic of the previous 24 hours/2 for day 2 and day 3; 2) Immediate release morphine orally = 10-20% of the total equianalgesic of the previous 24 hours; 3) Evaluate once every 24 hours
Primary Outcome Measure Information:
Title
Mean pain score
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. The mean pain score is a sum of NRS of day 1 (the day after successful titration of 24 hours) to day 3 divided by 3.
If the NRS of the morphine orally group >3, the NRS in the hydromorphone PCA intravenously group declines more than 30% compared to morphine orally group, which is regards a positive result.
Time Frame
From day1 to day3
Title
Number of Breakthrough cancer Pain (BTcP) episodes
Description
If NRS of the morphine orally group pain score ≤3 , or if NRS in the hydromorphone PCA intravenously group declines less than 30% compared to morphine orally group, number of Breakthrough cancer Pain (BTcP) episodes in the one of both the hydromorphone PCA intravenously group declines less than 30% compared to morphine orally group, which is regards a positive result.
Time Frame
From day1 to day3
Secondary Outcome Measure Information:
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
From day1 to day3
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
From day1 to day3
Title
Total dosage of opioids
Description
The total dosage of opioids in day 1 to day 3 (day 1 is the day after successful titration of 24 hours)
Time Frame
3 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
3 days
Title
Quality of life of patients
Description
Chinese version of the Edmonton Symptom Assessment System.
Time Frame
At 24 hours
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
3 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 tumor by pathology;
Patients with cancer pain is NRS pain score ≥ 7 during previous 24 hours;
Patients who will not be treated with radiotherapy within 7 days prior to randomization and during study ;
Patients who need chemotherapy, long term administration of hormone, targeted therapy, or bisphosphonates therapy should undergo a stable anti- tumor therapy prior to randomization ;
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;
Not participated in another drug clinical trial within one month before inclusion（including hydromorphone）;
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;
Those with opioid addiction;
Alcoholic patients;
Those with cognitive dysfunction;
Those with severe depression;
Patients with other conditions or reasons causing the patients unable to complete the clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rongbo Lin, MD
Organizational Affiliation
Fujian Cancer Hospital
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
Learn more about this trial
Intravenous vs Oral Analgesia in Cancer Patients With Severe Pain After Successful Titration
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