Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07169864

Simple Surgical Glove Compression to Prevent 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Chemotherapy Induced Peripheral Neuropathy (CIPN) Neoadjuvant Therapy Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, 200127, China

Location contact

Jinsong Lu

CONTACT

[email protected]

86(21)68385569

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Simple Surgical Glove Compression Technique

Procedure

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 outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jinsong Lu, M.D.

CONTACT

[email protected]

86(21)68385569

Sponsors and collaborators

Lead sponsor

Jinsong Lu

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 12, 2025
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.