Real Time Pressure ControllerNCT07019233
A Study of the Effect of Real-time Pressure Controllers on Subjective and Objective Symptoms of Peripheral Neuropathy Induced by Albumin Paclitaxel
A study of Real Time Pressure Controller and Breast Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
The purpose of the real-time pressure controller proposed in this experiment is to overcome the deficiencies of the existing technology and provide a pressure filling device for the prevention of chemotherapy-induced peripheral neuropathy that can accurately control the pressure, with the pressure decreasing in a… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Real Time Pressure Controller, Breast Cancer, Albumin Paclitaxel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily signed written informed consent;
- Age ≥18 years and ≤75 years at enrollment, male or female patients;
- Eastern Cooperative Oncology Group (ECOG) physical status score of 0 or 1;
- Suitable for albumin-paclitaxel antitumor therapy;
- Cardiopulmonary, hepatic, renal, and coagulation functions are basically normal.
Who cannot join
- Patients with prior chemotherapy;
- Patients with a prior diagnosis of peripheral neuropathy;
- Patients with a prior diagnosis of associated comorbidities (e.g., diabetes mellitus).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Yongsheng Jia, （022）65150123-8212, jiayongsheng@tjmuch.com
About this study
Official title: Effect of Real-time Pressure Controllers on Objective and Subjective Symptoms of Albumin Paclitaxel-induced Peripheral Neuropathy: a Prospective Controlled Research Project
The purpose of the real-time pressure controller proposed in this experiment is to overcome the deficiencies of the existing technology and provide a pressure filling device for the prevention of chemotherapy-induced peripheral neuropathy that can accurately control the pressure, with the pressure decreasing in a sequential manner from the distal end (toes/fingers) to the proximal end (wrists, limbs). The application of this device is of great clinical significance to reduce the peripheral neurotoxicity of paclitaxel and to improve patients' drug compliance. The application of cold compresses or gloves or socks with certain wrapping force is not suitable for the Chinese population, and the acceptance degree of Chinese patients is poor, and the pressure gloves lack individual specificity, and the precise control of pressure for real-time regulation cannot be realized, and the clinical effect is relatively poor. The purpose of this utility model device is to overcome the deficiencies of the existing technology, to provide a pressure filling device for the prevention of chemotherapy-induced peripheral neuropathy that can accurately control the pressure, and the pressure decreases in a sequential manner from the distal end (toes/fingers) to the proximal end (wrist, limb). After applying for the patent, it will be transformed into the market, which has a vast space of medical benefits and market benefits. Paclitaxel is the cornerstone drug in breast cancer chemotherapy, and the neuropathy it causes is often a key factor leading to drug reduction or discontinuation, so opening up the prevention of peripheral neuropathy caused by paclitaxel is of great clinical use.
- Being tested
- Real Time Pressure Controller
- Medical subject headings
- Breast Neoplasms, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real Time Pressure ControllerDevice
The purpose of the real-time pressure controller proposed in this experiment is to overcome the deficiencies of the existing technology and provide a pressure filling device for the prevention of chemotherapy-induced peripheral neuropathy that can accurately control the pressure, with the pressure decreasing in a sequential manner from the distal end (toes/fingers) to the proximal end (wrists, limbs). The application of this device is of great clinical significance to reduce the peripheral neurotoxicity of paclitaxel and to improve patients' drug compliance.
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | Not described |
| two-handed intervention | Experimental | Not described Receives: Device: Real Time Pressure Controller |
What is being measured
The primary outcome is the main question the study is designed to answer.
CIPN-related symptoms, as assessed by changes in tactile sensitivity at pretreatment baseline CIPN incidence.The Patient Neurotoxicity Questionnaire (PNQ) was used to assess and grade the incidence and severity of CIPN.
From the time a patient begins albumin paclitaxel therapy until the patient's treatment on this regimen is completed, or during albumin paclitaxel therapy, adverse reactions due to pressure gloves that result in patient patient disenrollment or voluntary.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start1 Sep 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Real Time Pressure ControllerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019233
- Sponsor's protocol ID
- TJIA2025
- Status last verified
- May 2025
- First submitted
- 15 May 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Real-time Pressure Controllers on Objective and Subjective Symptoms of Albumin Paclitaxel-induced Peripheral Neuropathy: a Prospective Controlled Research Project
- ClinicalTrials.gov ID
- NCT07019233
- Acronym / sponsor ID
- TJIA2025
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Jun 2025 (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.
The purpose of the real-time pressure controller proposed in this experiment is to overcome the deficiencies of the existing technology and provide a pressure filling device for the prevention of chemotherapy-induced peripheral neuropathy that can accurately control the pressure, with the pressure decreasing in a sequential manner from the distal end (toes/fingers) to the proximal end (wrists, limbs). The application of this device is of great clinical significance to reduce the peripheral neurotoxicity of paclitaxel and to improve patients' drug compliance. The application of cold compresses or gloves or socks with certain wrapping force is not suitable for the Chinese population, and the acceptance degree of Chinese patients is poor, and the pressure gloves lack individual specificity, and the precise control of pressure for real-time regulation cannot be realized, and the clinical effect is relatively poor. The purpose of this utility model device is to overcome the deficiencies of the existing technology, to provide a pressure filling device for the prevention of chemotherapy-induced peripheral neuropathy that can accurately control the pressure, and the pressure decreases in a sequential manner from the distal end (toes/fingers) to the proximal end (wrist, limb). After applying for the patent, it will be transformed into the market, which has a vast space of medical benefits and market benefits. Paclitaxel is the cornerstone drug in breast cancer chemotherapy, and the neuropathy it causes is often a key factor leading to drug reduction or discontinuation, so opening up the prevention of peripheral neuropathy caused by paclitaxel is of great clinical use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | – |
| two-handed intervention | Experimental | Device: Real Time Pressure Controller |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Voluntarily signed written informed consent;
- Age ≥18 years and ≤75 years at enrollment, male or female patients;
- Eastern Cooperative Oncology Group (ECOG) physical status score of 0 or 1;
- Suitable for albumin-paclitaxel antitumor therapy;
- Cardiopulmonary, hepatic, renal, and coagulation functions are basically normal.
Key exclusion criteria (3 listed)
- Patients with prior chemotherapy;
- Patients with a prior diagnosis of peripheral neuropathy;
- Patients with a prior diagnosis of associated comorbidities (e.g., diabetes mellitus).
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 |
|---|---|---|
| Real Time Pressure ControllerThe purpose of the real-time pressure controller proposed in this experiment is to overcome the deficiencies of the existing technology and provide a pressure filling device for the prevention of chemotherapy-induced peripheral neuropathy that can accurately control the pressure, with the pressure decreasing in a sequential manner from the distal end (toes/fingers) to the proximal end (wrists, limbs). The application of this device is of great clinical significance to reduce the peripheral neurotoxicity of paclitaxel and to improve patients' drug compliance. | Device | two-handed intervention |
Primary outcome
CIPN-related symptoms, as assessed by changes in tactile sensitivity at pretreatment baseline CIPN incidence.The Patient Neurotoxicity Questionnaire (PNQ) was used to assess and grade the incidence and severity of CIPN.
Time frame: through study completion, an average of 1 year
From the time a patient begins albumin paclitaxel therapy until the patient's treatment on this regimen is completed, or during albumin paclitaxel therapy, adverse reactions due to pressure gloves that result in patient patient disenrollment or voluntary.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Real Time Pressure Controller and Breast Cancer, run by Tianjin Medical University Cancer Institute and Hospital 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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 13 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yongsheng Jia (（022）65150123-8212, jiayongsheng@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CIPN-related symptoms, as assessed by changes in tactile sensitivity at pretreatment baseline CIPN incidence.The Patient Neurotoxicity Questionnaire (PNQ) was used to assess and grade the incidence and severity of CIPN. (time frame: through study completion, an average of 1 year). 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 13 Jun 2025.