Cancer Pain
Conditions
Keywords
Orally, IV PCA with continuous + bolus dose, IV PCA with bolus-only dose
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.
Interventions
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.
DRUGMorphine 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;
Sponsors
Fujian Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3DNRS (3-day average Numeric Rating Scale) | up to 4 days | 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. 3DNRS 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with an average NRS pain score > 6 | up to 7 days | 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 >3 | up to 7 days | 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. |
| Maximum NRS (Days 1 to 6) | up to 7 days | Maximum NRS score (Days 1 to 6) |
| Daily frequency and duration of breakthrough cancer pain | up to 7 days | Daily frequency and duration of breakthrough cancer pain (defined as transient pain exacerbation \[NRS ≥4\]) |
| Daily equivalent morphine consumption | up to 7 days | Daily equivalent morphine consumption |
| Adverse events | up to 8 days | assessed by NCI-CTCAE v5.0 |
| Improvement in physical symptoms and overall well-being | up to 7 days | assessed by Chinese version of the Edmonton Symptom Assessment System. |
| Patient Satisfaction Score | up to 7 days | 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. |
| Daily avNRS score of days 1 to 6 | up to 7 days | Daily average NRS pain score of days 1 to 6 |
Countries
China
Outcome results
None listed