An interventional study of PCA pump in Cancer Pain, Tumor, Solid and Carcinoma, sponsored by The First Affiliated Hospital of Xinxiang Medical College. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-28.
Sponsored by The First Affiliated Hospital of Xinxiang Medical College · Not applicable, Interventional, and Treatment
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.
This is a single-arm multicenter study that will involve 8-10 centers and 50 cases in total. A better pumping mode was discovered through repeated optimization and adjustment of PCA pump parameters, ensuring the unity of convenience, safety, and flexibility: on the one hand, it is convenient for clinicians to set up and adjust the pump quickly; on the other hand, it is also convenient for patients to control at home; thus, it solves the complex pumping and dosing problems. Nearly 20 patients with severe cancer pain or a cancer pain crisis were treated using this model, and the control satisfaction rate was 100% in each case.
The purpose of this study is to:
338 studies on the registry are indexed under Cancer Pain; 71 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 254 interventional studies indexed under Cancer Pain.
Browse Cancer Pain studies →The First Affiliated Hospital of Xinxiang Medical College is the lead sponsor of 41 studies on the registry; 37 are open to participants now.
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Exclusion Criteria:
Device: PCA pump
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.
Pain score
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.
Time frame: 10 days
The frequency of paroxysmal pain
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.
Time frame: 10 days
Life quality
The WHOQOL-BREF is a 26-item self-assessment questionnaire that investigates the last two weeks of physical health, mental health, social relationships, and environment. It allows for a reliable, valid and brief assessment of quality of life. In this study, the psychological domain (6 items) was used to represent the psychological aspects of quality of life.
Time frame: 10 days
The evaluation of PCA home feasibility
During the trial, monitoring the number of occurrences of PCA blockage and reflux in patients, as well as will record the number of times they seek help from healthcare professionals in case of PCA pump-related problems that cannot be solved by themselves.
Time frame: 10 days
The concentration of immune-related cytokines
the content of PD 1, IL-2, IL-6, STING, CD3+, CD4+, IFN-1and IFN-γ in patients' serum
Time frame: 10 days
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Xinxiang Medical College