Breast CancerNCT07169864
Simple Surgical Glove Compression to Prevent Chemotherapy-Induced Peripheral Neuropathy
A study testing Simple Surgical Glove Compression Technique in people with Breast Cancer and Chemotherapy Induced Peripheral Neuropathy (CIPN), run by Jinsong Lu at 1 site in China.
Trial summary
To evaluate the preventive efficacy of a simple surgical glove compression technique in reducing the incidence and severity of Chemotherapy Induced Peripheral Neuropathy among patients receiving chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Chemotherapy Induced Peripheral Neuropathy (CIPN), Neoadjuvant Therapy
- What is being tested?
- Simple Surgical Glove Compression Technique
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2025to 31 Dec 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- Histologically confirmed primary invasive breast cancer;
- Planned to receive ≥ 8 weeks of weekly neoadjuvant chemotherapy (utidelone plus cisplatin);
- ECOG performance status: 0-1;
Who cannot join
- Distant metastasis;
- Presence of sensory or motor neurological disorders, or symptoms related to peripheral neuropathy with CTCAE grade ≥ 2, or currently receiving medication for peripheral neuropathy;
- Conditions affecting limb function;
- Known allergy to glove materials (e.g., latex)
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
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, 200127
Jinsong Lu, 86(21)68385569, lujingsong@renji.com
About this study
Official title: An Exploratory Self-Controlled Study on the Preventive Effect of the Simple Surgical Glove Compression Technique Against Chemotherapy-Induced Peripheral Neuropathy
To evaluate the preventive efficacy of a simple surgical glove compression technique in reducing the incidence and severity of Chemotherapy Induced Peripheral Neuropathy among patients receiving chemotherapy.
- Being tested
- Simple Surgical Glove Compression Technique
- Keywords
- Utidelone, CIPN, Neoadjuvant chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simple Surgical Glove Compression TechniqueProcedure or surgery
Patients will wear surgical gloves of smaller size than the patient's hand, on the dominant hand from 15 minutes before the start of each neoadjuvant chemotherapy infusion until 15 minutes after the end of infusion (total of 90 minutes). The non-dominant hand will serve as the untreated control.
| Study group | Role | What they receive |
|---|---|---|
| Group with surgical glove compression applied to the dominant hand | Experimental | Not described Receives: Procedure: Simple Surgical Glove Compression Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the functional assessment of cancer therapy/gynaecologic oncology group-neurotoxicity (FACT/GOG-Ntx) subscale score(range:-44to44; higher scores indicate better neurotoxicity-related quality of life).
Measured: From baseline (prior to neoadjuvant chemotherapy) to after 8 weeks of neoadjuvant chemotherapy in breast cancer
Secondary outcomes (6)
Change in scores and the sum score of four hand-related items of the FACT/GOG-Ntx subscale (range: -16to+16; higher scores indicate better neurotoxicity-related quality of life).
Measured: From baseline (prior to neoadjuvant chemotherapy) to after 8 weeks of neoadjuvant chemotherapy in breast cancer
The overall change in the FACT/GOG-Ntx subscale score (range: -44to44; higher scores indicate better neurotoxicity-related quality of life)
Measured: From baseline to the end of neoadjuvant chemotherapy and 6 months after completion of neoadjuvant chemotherapy
Incidence of CIPN as determined by changes in tactile sensitivity assessed with the Semmes-Weinstein monofilament test
Measured: From baseline to the end of and 6 months after completion of neoadjuvant chemotherapy
Incidence of CIPN according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: From baseline to the end of and 6 months after completion of neoadjuvant chemotherapy
Changes in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores (range: -12to12, higher scores on functional and global health domains indicate better quality of life,; -84to84; while higher
Measured: At baseline (prior to initiation of neoadjuvant chemotherapy), at 8 weeks of neoadjuvant chemotherapy, at 2 weeks after completion of neoadjuvant chemotherapy, and at 6 months after completion of neoadjuvant chemotherapy.
Changes in the maximum width and height of the lunula of each finger
Measured: At baseline (prior to initiation of neoadjuvant chemotherapy), at 8 weeks of neoadjuvant chemotherapy, at 2 weeks after completion of neoadjuvant chemotherapy, and at 6 months after completion of neoadjuvant chemotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinsong Lu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jinsong Lu, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169864
- Sponsor's protocol ID
- LY2025-246-C
- Status last verified
- Aug 2025
- First submitted
- 27 Aug 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Self-Controlled Study on the Preventive Effect of the Simple Surgical Glove Compression Technique Against Chemotherapy-Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07169864
- Acronym / sponsor ID
- LY2025-246-C
- Keywords
- Utidelone, CIPN, Neoadjuvant chemotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Jinsong LuUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Sep 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.
To evaluate the preventive efficacy of a simple surgical glove compression technique in reducing the incidence and severity of Chemotherapy Induced Peripheral Neuropathy among patients receiving chemotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group with surgical glove compression applied to the dominant hand | Experimental | Procedure: Simple Surgical Glove Compression Technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years;
- Histologically confirmed primary invasive breast cancer;
- Planned to receive ≥ 8 weeks of weekly neoadjuvant chemotherapy (utidelone plus cisplatin);
- ECOG performance status: 0-1;
Key exclusion criteria (4 listed)
- Distant metastasis;
- Presence of sensory or motor neurological disorders, or symptoms related to peripheral neuropathy with CTCAE grade ≥ 2, or currently receiving medication for peripheral neuropathy;
- Conditions affecting limb function;
- Known allergy to glove materials (e.g., latex)
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 |
|---|---|---|
| Simple Surgical Glove Compression TechniquePatients will wear surgical gloves of smaller size than the patient's hand, on the dominant hand from 15 minutes before the start of each neoadjuvant chemotherapy infusion until 15 minutes after the end of infusion (total of 90 minutes). The non-dominant hand will serve as the untreated control. | Procedure or surgery | Group with surgical glove compression applied to the dominant hand |
Primary outcome
Change in the functional assessment of cancer therapy/gynaecologic oncology group-neurotoxicity (FACT/GOG-Ntx) subscale score(range:-44to44; higher scores indicate better neurotoxicity-related quality of life).
Time frame: From baseline (prior to neoadjuvant chemotherapy) to after 8 weeks of neoadjuvant chemotherapy in breast cancer
6 secondary outcomes
Change in scores and the sum score of four hand-related items of the FACT/GOG-Ntx subscale (range: -16to+16; higher scores indicate better neurotoxicity-related quality of life).
Time frame: From baseline (prior to neoadjuvant chemotherapy) to after 8 weeks of neoadjuvant chemotherapy in breast cancer
The overall change in the FACT/GOG-Ntx subscale score (range: -44to44; higher scores indicate better neurotoxicity-related quality of life)
Time frame: From baseline to the end of neoadjuvant chemotherapy and 6 months after completion of neoadjuvant chemotherapy
Incidence of CIPN as determined by changes in tactile sensitivity assessed with the Semmes-Weinstein monofilament test
Time frame: From baseline to the end of and 6 months after completion of neoadjuvant chemotherapy
Incidence of CIPN according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: From baseline to the end of and 6 months after completion of neoadjuvant chemotherapy
Changes in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores (range: -12to12, higher scores on functional and global health domains indicate better quality of life,; -84to84; while higher
Time frame: At baseline (prior to initiation of neoadjuvant chemotherapy), at 8 weeks of neoadjuvant chemotherapy, at 2 weeks after completion of neoadjuvant chemotherapy, and at 6 months after completion of neoadjuvant chemotherapy.
Changes in the maximum width and height of the lunula of each finger
Time frame: At baseline (prior to initiation of neoadjuvant chemotherapy), at 8 weeks of neoadjuvant chemotherapy, at 2 weeks after completion of neoadjuvant chemotherapy, and at 6 months after completion of neoadjuvant chemotherapy.
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 12 Sep 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simple Surgical Glove Compression Technique in people with Breast Cancer and Chemotherapy Induced Peripheral Neuropathy (CIPN), run by Jinsong Lu 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 12 Sep 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 Jinsong Lu, M.D. (86(21)68385569, lujingsong@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the functional assessment of cancer therapy/gynaecologic oncology group-neurotoxicity (FACT/GOG-Ntx) subscale score(range:-44to44; higher scores indicate better neurotoxicity-related quality of life). (time frame: From baseline (prior to neoadjuvant chemotherapy) to after 8 weeks of neoadjuvant chemotherapy in breast cancer). 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 12 Sep 2025.