Clinical trial · Interventional
Home Management of Simple Hydromorphone PCA Pump Mode
A Single-arm Multicenter Study on the Home Management of Simple Hydromorphone PCA Pump Mode in Cancer Patients Suffering Severe or Critically Painful
NCT05744089CI-TRIAL-00064295unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This prospective observational study will evaluate the efficacy and adverse effects of a "simple hydromorphone PCA pump model", which is a rapid titration followed by a convenient maintenance technique, to treat home cancer patients with severe or critical cancer pain or refractory cancer pain.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Pain | — | UNRESOLVED | — |
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Tumor, Solid | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PCA pump | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cancer patients suffering severe or critically painful
- interventionNames
- Device: PCA pump
Primary outcomes (4)
- measure
- Pain score
- timeFrame
- 10 days
- description
- Subjects self-assess on the NRS pain rating scale in the subject log sheet, where subjects assess the level of cancer pain experienced in the past 24 hours.
- measure
- The frequency of paroxysmal pain
- timeFrame
- 10 days
- description
- Paroxysmal pain is defined as a sudden and transient pain exacerbation that occurs spontaneously or triggered by some predictable or unpredictable factors under the premise of relatively stable background pain control and adequate application of analgesic drugs. The onset, duration and number of cancer eruption pain episodes were recorded by the subjects in the logbook at the time of the episode.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years. 2. Patients with pathologically confirmed malignant solid tumors; patients with advanced metastatic cancer assessed by imaging 3. Patients with persistent cancer pain and an NRS score of ≥7 in the past 24 hours; or patients with refractory pain 4. Patients who have not received radiation therapy within 7 days prior to randomization and trial 5. Patients without cognitive impairment or mental illness. 6. the patient is able to complete the survey form 7. Patients can correctly understand and cooperate with the healthcare provider's medication instructions. 8. ECOG-PS ≤ 3 points. 9. Subjects voluntarily and signed the informed consent form. 10. Failure of antineoplastic treatment or refusal of antineoplastic treatment at home or community hospital. Exclusion Criteria: 1. Patients with a diagnosis of non-cancerous pain or pain of unknown origin. 2. Patients receiving inpatient antineoplastic therapy. 3. patients with paralytic intestinal obstruction 4. patients with opioid allergy. 5. abnormal and clinically significant laboratory results, such as creatinine ≥ 2 times the upper limit of normal, ALT or AST ≥ 2.5 times the upper limit of normal (≥ 5 times the upper limit of normal in patients with liver metastases or primary hepatocellular carcinoma), or grade C liver function Child 6. Uncontrollable nausea and vomiting. 7. Use of monoamine oxidase inhibitors within 14 days prior to randomization. 8. pregnant or lactating women; subjects with a planned pregnancy within 1 month of trial (also includes male subjects) 9. Patients with alcohol abuse. 10. Other diseases and conditions that, in the opinion of the investigator, preclude enrollment.
References
Publications (0)
Data not yet available
No reference posted for this study.