Cancer PainNCT05744089
Home Management of Simple Hydromorphone PCA Pump Mode
A study testing PCA pump in people with Cancer Pain and Tumor, Solid, run by The First Affiliated Hospital of Xinxiang Medical College at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Pain, Tumor, Solid, Carcinoma
- What is being tested?
- PCA pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Feb 2023to Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453100
About this study
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
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.
Read the 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.
- Conditions
- Cancer Pain, Tumor, Solid, Carcinoma
- Being tested
- PCA pump
- Medical subject headings
- Cancer Pain, Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCA pumpDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients suffering severe or critically painful | Experimental | Not described Receives: Device: PCA pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 days
Secondary outcomes (1)
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
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study startFeb 2023 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744089
- Sponsor's protocol ID
- PCA001
- Status last verified
- Feb 2023
- First submitted
- 13 Feb 2023
- Last updated
- 28 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05744089
- Acronym / sponsor ID
- PCA001
- Conditions
- Cancer Pain, Tumor, Solid, Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical CollegeUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 24 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer patients suffering severe or critically painful | Experimental | Device: PCA pump |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCA pumpsimple 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. | Device | Cancer patients suffering severe or critically painful |
Primary outcome
Pain score
Time frame: 10 days
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
Time frame: 10 days
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
Time frame: 10 days
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
Time frame: 10 days
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.
1 secondary outcome
The concentration of immune-related cytokines
Time frame: 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCA pump in people with Cancer Pain and Tumor, Solid, run by The First Affiliated Hospital of Xinxiang Medical College at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: 10 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023; AzTrials last refreshed its copy on 6 Nov 2026.