Surgical Glove Compression to Prevent Paclitaxel Neuropathy

NCT07504770 | Not Yet Recruiting DMC

• 1 other identifier: 24272
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effect of surgical glove compression as a prophylactic method to prevent paclitaxel-induced peripheral neuropathy. Participants will be randomly assigned to two groups: one receiving standard care, and the other receiving prophylactic surgical glove compression. The study will compare the development, severity of neuropathy in the hands and fingers, and its impact on quality of life.

Conditions

Paclitaxel-Induced Peripheral Neuropathy; Breast Cancer; Surgical Glove

Keywords

Surgical Glove; Paclitaxel-Induced Peripheral Neuropathy; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT)

  The first section assesses the nine main symptoms as well as their severity, the extent to which they cause emotional disruption, and the frequency of their occurrence. The first six items in this section are related to sensory symptoms, while the seventh, eighth and ninth items are related to sub-dimensions of motor symptoms. In the second part, 14 activities were evaluated and questions were asked about the effect level of these substances. The activities assessed included fine motor and general activities. To assess the symptoms listed in the first section, "Yes" was considered equal to 1 point and "No" equal to 0 (0-9); their severity, symptoms, extent and frequency of emotional impairment were scored between 0 and 10 (0-270). The total score for the first part of the instrument is between 0 and 279. The effect level on the 14 activities in the second part was calculated between 0 and 10 (0-140). The Cronbach's alpha value of the original scale is 0.95

  4 weeks after the first assessment

Study Arms (3)

Intervention Group 1

OTHER

A standard surgical glove (½ size smaller) will be worn on the same hand 30 minutes before, during, and 30 minutes after paclitaxel infusion. Glove size will be determined by the study nurse based on hand measurements.

Other: Surgical glove compression during paclitaxel infusion

Intervention Group 2

OTHER

Two standard surgical gloves will be worn on the same hand: first ½ size smaller, second 1 size smaller. Gloves will be worn 30 minutes before, during, and 30 minutes after paclitaxel infusion. Glove sizes determined by study nurse.

Other: Surgical glove compression during paclitaxel infusion

Control Group

OTHER

Patients will receive standard clinical care only, with no additional intervention.

Other: Surgical glove compression during paclitaxel infusion

Interventions

Surgical glove compression during paclitaxel infusion OTHER

n the intervention group, each patient will wear two standard surgical gloves on the same single hand throughout the study (the first glove will be half a size smaller, the second glove one size smaller). The gloves will be worn 30 minutes before the paclitaxel infusion, during the infusion, and for 30 minutes after the infusion. This procedure will be performed each time the patient comes for treatment. No additional interventions will be applied besides the surgical gloves. The gloves must fit the patients' hands properly, and the study nurse will determine the appropriate glove size for each patient.

Control Group; Intervention Group 1; Intervention Group 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged between 18 and 80 years
• Diagnosed with Stage II-III breast cancer
• No distant metastasis
• Planned to receive adjuvant or neoadjuvant paclitaxel for at least 12 weeks
• Willing and able to provide informed consent
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 Karnofsky ≥ 60%)

You may not qualify if:

• Recurrent breast cancer
• Prior treatment associated with neuropathy (e.g., taxanes, platinum-based chemotherapy, anti-tubulin or proteasome inhibitors)

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettin Erbakan University, Faculty of Health Sciences

Konya, Meram, 42060, Turkey (Türkiye)

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

Deniz Özdemir, Phd

CONTACT

+905066087130; dnzzzzdmr@gmail.com

Selda Arslan, Associate Professor

CONTACT

+905439253200; seldayarali@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In addition to participants and study staff, outcome assessors and data analysts will be blinded to group assignments to minimize bias in evaluating peripheral neuropathy and quality of life outcomes.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD

Model Details: Prospective randomized controlled clinical trial

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 1, 2026
• Study Start: March 26, 2026
• Primary Completion (Estimated): October 26, 2026
• Study Completion (Estimated): March 26, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)