Intravenous vs Oral Analgesia in Cancer Patients With Severe Pain After Successful Titration

NCT ID: NCT04243954

Last Updated: 2021-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-10
• Study Completion Date: 2020-11-21

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.

Conditions

Cancer Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral Morphine

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. 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

Group Type: ACTIVE_COMPARATOR

Oral morphine

Intervention Type: DRUG

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

PCA IV Hydromorphone (continuous dose = 0)

1. Intravenous PCA with hydromorphone after successful titration of 24 hours.

2. 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

Group Type: EXPERIMENTAL

PCA IV Hydromorphone (continuous dose = 0)

Intervention Type: DRUG

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

PCA IV Hydromorphone (continuous dose ≠ 0)

1. Intravenous PCA with hydromorphone after successful titration of 24 hours.

2. 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

Group Type: EXPERIMENTAL

PCA IV Hydromorphone (continuous dose ≠ 0)

Intervention Type: DRUG

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

Interventions

PCA IV Hydromorphone (continuous dose = 0)

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

PCA IV Hydromorphone (continuous dose ≠ 0)

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

Oral morphine

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

Eligibility Criteria

Inclusion Criteria

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

2. Patients with cancer pain is NRS pain score ≥ 7 during previous 24 hours;

3. Patients who will not be treated with radiotherapy within 7 days prior to randomization and during study ;

4. Patients who need chemotherapy, long term administration of hormone, targeted therapy, or bisphosphonates therapy should undergo a stable anti- tumor therapy prior to randomization ;

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

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

7. Without psychiatric problems;

8. ECOG performance status ≤3;

9. Not participated in another drug clinical trial within one month before inclusion（including hydromorphone）;

10. 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. Those with opioid addiction;

12. Alcoholic patients;

13. Those with cognitive dysfunction;

14. Those with severe depression;

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rongbo Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Fujian Cancer Hospital

Locations

China, Fujian

Fuzhou, Fujian, China

Countries

China

Other Identifiers

HMORCT09-2

Identifier Type: -

Identifier Source: org_study_id