Surgical Glove Compression to Prevent Paclitaxel Neuropathy (Surgical Glove)

Comparison of Surgical Glove Compressions as a Prophylactic Method to Prevent Paclitaxel-induced Peripheral Neuropathy: Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer; Surgical Glove; Paclitaxel-Induced Peripheral Neuropathy
• Intervention / Treatment: Other: Surgical glove compression during paclitaxel infusion

Detailed Description

This study aims to evaluate the effectiveness of surgical glove compression to prevent peripheral neuropathy in patients receiving paclitaxel. Participants will be divided into two groups: one receiving standard care, and the other receiving glove compression. The study will compare the development and severity of neuropathy in the hands and fingers, as well as its impact on quality of life. This method is considered a practical, cost-effective, and well-tolerated preventive approach.

Method:

Patients receiving paclitaxel will be randomly assigned to either the intervention or control group.

Intervention Group 1: Each patient will wear a standard surgical glove (½ size smaller) on the same hand for all treatment sessions. Since surgeons typically use gloves that fit their hands perfectly, a standard-sized surgical glove is defined as a "surgeon fit." Gloves will be worn 30 minutes before paclitaxel infusion, during the infusion, and 30 minutes after the infusion. This procedure will be repeated at every treatment session. No additional interventions will be applied. Gloves must fit the patient's hands properly. The study nurse will determine the appropriate glove size for each patient by measuring from the base of the palm to the tip of the middle finger. The measurements will be converted to glove sizes using a reference table.

Intervention Group 2: Each patient will wear two standard surgical gloves on the same hand: the first ½ size smaller and the second one size smaller. Gloves will be worn 30 minutes before paclitaxel infusion, during the infusion, and 30 minutes after. This procedure will be repeated at every treatment session. No additional interventions will be applied. Gloves must fit the patient's hands properly. The study nurse will determine the appropriate glove size for each patient.

Control Group: Patients in the control group will receive standard clinical care only, without any additional interventions.

Widespread Effect If effective, surgical glove compression could provide a simple, low-cost, and widely accessible method to prevent paclitaxel-induced peripheral neuropathy, improving quality of life for patients undergoing chemotherapy and potentially influencing supportive care practices in oncology settings.

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deniz Özdemir, Phd; Phone Number: +905066087130; Email: dnzzzzdmr@gmail.com
• Study Contact Backup: Name: Selda Arslan, Associate Professor; Phone Number: +905439253200; Email: seldayarali@hotmail.com

Study Locations

• Turkey (Türkiye)
  • Meram
    • Konya, Meram, Turkey (Türkiye), 42060
      • Necmettin Erbakan University, Faculty of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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%)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention Group 1; 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; 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.
Other: Intervention Group 2; 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; 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.
Other: Control Group; Patients will receive standard clinical care only, with no additional intervention.	Other: Surgical glove compression during paclitaxel infusion; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Necmettin Erbakan University

Study record dates

Study Major Dates

• Study Start (Estimated): March 26, 2026
• Primary Completion (Estimated): October 26, 2026
• Study Completion (Estimated): March 26, 2027

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Breast Cancer; Surgical Glove; Paclitaxel-Induced Peripheral Neuropathy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 24272

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) from this study will not be shared due to patient privacy concerns and institutional regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No