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Not yet recruiting NCT07169864

Simple Surgical Glove Compression to Prevent Chemotherapy-Induced Peripheral Neuropathy

No phase Interventional Breast Cancer Chemotherapy Induced Peripheral Neuropathy (CIPN) Neoadjuvant Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Simple Surgical Glove Compression Technique.
Who it may be relevant to
Registry conditions: Breast Cancer, Chemotherapy Induced Peripheral Neuropathy (CIPN), Neoadjuvant Therapy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

An Exploratory Self-Controlled Study on the Preventive Effect of the Simple Surgical Glove Compression Technique Against Chemotherapy-Induced Peripheral Neuropathy

Overview

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.

Interventions

  • Procedure Simple Surgical Glove Compression Technique
    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.

Primary outcome measures

  • 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]
Secondary outcome measures (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). [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.]

Eligibility criteria

Inclusion criteria

  • 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;

Exclusion criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

China · 1 center
  • Renji Hospital, School of Medicine, Shanghai Jiaotong University — Shanghai

Identifiers

NCT: NCT07169864 · LY2025-246-C

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗