IV PCA With or Without Continuous Dose vs Oral Opioid to Maintain Analgesia for Severe Cancer Pain After Successful Titration

Cancer Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04785768
• Other study ID #: SYLT021/HMORCT09-3
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 1, 2021
• Est. completion date: July 1, 2024

Study information

• Verified date: February 2021
• Source: Fujian Cancer Hospital
• Contact: Rongbo Lin, MD
• Phone: 86+13705919382
• Email: rongbo_lin[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1600
• Est. completion date: July 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. The patients were 18-80 years old and diagnosed as malignant solid tumor by pathology;

2. Patients with persistent cancer pain and NRS score = 7 during previous 24 hours;

3. Patients who did not receive radiotherapy, chemotherapy or targeted therapy within 7 days before randomization and trial;

4. Patients or his/her caregivers who are able to fill out the questionnaire forms ;

5. Ability to correctly understand and cooperate with medication guidance of doctors and nurses ;

6. Without psychiatric problems;

7. ECOG performance status =3;

8. Patients who did not receive the trial drug within 14 days before the trial;

9. The subjects voluntarily signed the informed consent.

Exclusion Criteria:

1. The pain is confirmed not due to cancer;

2. Patients with severe post-operative pain;

3. Patients with paralytic ileus;

4. Patients with brain metastasis;

5. Patients hypersensitive to opioids;

6. 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;

7. Patients who cannot take drugs orally;

8. Patients with an incoercible nausea or vomiting;

9. Those who have received monoamine oxidase inhibitor (MAOI) within two weeks before randomization;

10. Patients who are pregnant or in lactation, or who plan to be pregnant within one month after the trial;

11. Alcoholic patients;

12. Patients with other conditions or reasons causing the patients unable to complete the clinical trial.

Related Conditions & MeSH terms

• Cancer Pain

Intervention

Drug:
• Hydromorphone Hydrochloride Injection
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.
• Hydromorphone Hydrochloride Injection
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.
• Morphine Sulfate Sustained-release Tablets
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;

Locations

Country	Name	City	State
China	China, Fujian	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	up to 7 days
Other	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.	up to 7 days
Other	Daily opioid dosage	Daily opioid dosage	up to 7 days
Other	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.	up to 7 days
Other	Quality of life of patients	Chinese version of the Edmonton Symptom Assessment System.	up to 7 days
Other	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	up to 7 days
Primary	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).	up to 4 days
Primary	Number of Breakthrough cancer Pain (BTcP)	Breakthrough cancer Pain (BTcP) is NRS > 3	up to 4 days
Secondary	Mean pain score of days 1 to 6	Mean pain score is a sum of average NRS of D1 to D6 divided by 6	up to 7 days