Simple Surgical Glove Compression to Prevent Chemotherapy-Induced Peripheral Neuropathy

NCT07169864 | Not Yet Recruiting

• 1 other identifier: LY2025-246-C
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Chemotherapy Induced Peripheral Neuropathy (CIPN); Neoadjuvant Therapy

Keywords

Utidelone; CIPN; Neoadjuvant chemotherapy

Outcome Measures

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).

  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).

  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)

  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

  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

  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

  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 Arms (1)

Group with surgical glove compression applied to the dominant hand

EXPERIMENTAL

Procedure: Simple Surgical Glove Compression Technique

Interventions

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.

Group with surgical glove compression applied to the dominant hand

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jinsong Lu: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, 200127, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Jinsong Lu, M.D.

CONTACT

86(21)68385569; lujingsong@renji.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Department of Breast Surgery

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 12, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 12, 2025

Record last verified: 2025-08

Locations

CN (1)