Simple Surgical Glove Compression to Prevent Chemotherapy-Induced Peripheral Neuropathy

NCT ID: NCT07169864

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2027-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group with surgical glove compression applied to the dominant hand

Group Type: EXPERIMENTAL

Simple Surgical Glove Compression Technique

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jinsong Lu

OTHER

Sponsor Role: lead

Responsible Party

Jinsong Lu

Chief of Department of Breast Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, , China

Countries

China

Central Contacts

Jinsong Lu, M.D.

Role: CONTACT

lujingsong@renji.com

86(21)68385569

Facility Contacts

Jinsong Lu

Role: primary

lujingsong@renji.com

86(21)68385569

Other Identifiers

LY2025-246-C

Identifier Type: -

Identifier Source: org_study_id