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

Fujian Provincial Cancer Hospital

Status and phase: Completed; Phase 3

Conditions: Cancer Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04785768

SYLT021/HMORCT09-3

Details and patient eligibility

About

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.

Enrollment: 1,372 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,372 participants in 3 patient groups

PCA with continuous + bolus dose

Experimental group

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.

Treatment:

Drug: Hydromorphone Hydrochloride Injection

Drug: Hydromorphone Hydrochloride Injection

PCA with bolus-only dose

Experimental group

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.

Treatment:

Drug: Hydromorphone Hydrochloride Injection

Drug: Hydromorphone Hydrochloride Injection

Oral opioid

Active Comparator group

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.

Treatment:

Drug: Morphine Sulfate Sustained-release Tablets