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NCT05744089
Home Management of Simple Hydromorphone PCA Pump Mode
Conditions: Cancer Pain, Tumor, Solid, Carcinoma
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 50
Sponsor: The First Affiliated Hospital of Xinxiang Medical College
Location: China
Summary
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.
Eligibility Criteria
Inclusion Criteria:Age ≥ 18 years.Patients with pathologically confirmed malignant solid tumors; patients with advanced metastatic cancer assessed by imagingPatients with persistent cancer pain and an NRS score of ≥7 in the past 24 hours; or patients with refractory painPatients who have not received radiation therapy within 7 days prior to randomization and trialPatients without cognitive impairment or mental illness.the patient is able to complete the survey formPatients can correctly understand and cooperate with the healthcare provider's medication instructions.ECOG-PS ≤ 3 points.Subjects voluntarily and signed the informed consent form.Failure of antineoplastic treatment or refusal of antineoplastic treatment at home or community hospital.Exclusion Criteria:Patients with a diagnosis of non-cancerous pain or pain of unknown origin.Patients receiving inpatient antineoplastic therapy.patients with paralytic intestinal obstructionpatients with opioid allergy.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 ChildUncontrollable nausea and vomiting.Use of monoamine oxidase inhibitors within 14 days prior to randomization.pregnant or lactating women; subjects with a planned pregnancy within 1 month of trial (also includes male subjects)Patients with alcohol abuse.Other diseases and conditions that, in the opinion of the investigator, preclude enrollment.
Source: ClinicalTrials.gov (NCT05744089). StuddyBuddy aggregates publicly available trial information.