Home Management of Simple Hydromorphone PCA Pump Mode

NCT05744089 | Unknown

• 1 other identifier: PCA001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer Pain; Tumor, Solid; Carcinoma

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  10 days

Secondary Outcomes (1)

• The concentration of immune-related cytokines

  10 days

Study Arms (1)

Cancer patients suffering severe or critically painful

EXPERIMENTAL

Device: PCA pump

Interventions

PCA pump DEVICE

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.

Cancer patients suffering severe or critically painful

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Patients with pathologically confirmed malignant solid tumors; patients with advanced metastatic cancer assessed by imaging
• Patients with persistent cancer pain and an NRS score of ≥7 in the past 24 hours; or patients with refractory pain
• Patients who have not received radiation therapy within 7 days prior to randomization and trial
• Patients without cognitive impairment or mental illness.
• the patient is able to complete the survey form
• Patients 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.

You may not qualify if:

• Patients with a diagnosis of non-cancerous pain or pain of unknown origin.
• Patients receiving inpatient antineoplastic therapy.
• patients with paralytic intestinal obstruction
• patients 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 Child
• Uncontrollable 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Xinxiang Medical College: lead

Study Sites (1)

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, 453100, China

Location

MeSH Terms

Conditions

Cancer Pain; Neoplasms; Carcinoma

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 24, 2023
• Study Start: February 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2025
• Last Updated: February 28, 2023

Record last verified: 2023-02

Locations

CN (1)