Back to resultsHome Management of Simple Hydromorphone PCA Pump Mode
Primary Purpose
Cancer Pain, Tumor, Solid, Carcinoma
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PCA pump
Sponsored by
About this trial
This is an interventional treatment trial for Cancer Pain
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- The First Affiliated Hospital of Xinxiang Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cancer patients suffering severe or critically painful
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05744089
First Posted
February 13, 2023
Last Updated
February 24, 2023
Sponsor
The First Affiliated Hospital of Xinxiang Medical College
1. Study Identification
Unique Protocol Identification Number
NCT05744089
Brief Title
Home Management of Simple Hydromorphone PCA Pump Mode
Official Title
A Single-arm Multicenter Study on the Home Management of Simple Hydromorphone PCA Pump Mode in Cancer Patients Suffering Severe or Critically Painful
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Xinxiang Medical College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
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:
Main objective: To explore the efficacy and adverse effects of a simple hydromorphone PCA pump model, i.e., rapid titration followed by maintenance, for the treatment of patients with severe cancer pain or cancer pain crisis or refractory cancer pain in home cancer patients.
Exploratory purpose: To screen sensitive indicators for cancer pain assessment and efficacy monitoring by Ella fully automated microfluidic ELISA system, and to explore the mechanism of action of pain-causing substances in cancer pain initially.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Pain, Tumor, Solid, Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cancer patients suffering severe or critically painful
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
PCA pump
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain score
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.
Time Frame
10 days
Title
The frequency of paroxysmal pain
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.
Time Frame
10 days
Title
Life quality
Description
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
Title
The evaluation of PCA home feasibility
Description
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
Secondary Outcome Measure Information:
Title
The concentration of immune-related cytokines
Description
the content of PD 1, IL-2, IL-6, STING, CD3+, CD4+, IFN-1and IFN-γ in patients' serum
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
The First Affiliated Hospital of Xinxiang Medical University
City
Xinxiang
State/Province
Henan
ZIP/Postal Code
453100
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Home Management of Simple Hydromorphone PCA Pump Mode
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