Glove Compression for Chemotherapy-Induced Neuropathy

NCT07105553 | Completed

• 1 other identifier: AEŞH-EK1-2023-828
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates whether wearing tight-fitting surgical gloves on the non-dominant hand could help prevent chemotherapy-induced peripheral neuropathy (CIPN) in women with gynecologic cancers treated with paclitaxel. In this prospective, self-controlled observational study, seventy-six patients wear two tight surgical gloves on their non-dominant hand during each paclitaxel infusion. The dominant hand, without gloves, serves as a control. Neuropathy symptoms are assessed using the EORTC QLQ-CIPN20 questionnaire at baseline, mid-treatment, and end of treatment. Electromyography (EMG) is performed if clinically indicated.

Conditions

Chemotherapy-induced Peripheral Neuropathy (CIPN); Gynecologic Cancers; Ovarian Cancer (OvCa); Endometrial Cancer

Keywords

Peripheral Neuropathy; CIPN; Taxane Toxicity; Surgical Glove Compression; Supportive Care in Oncology; EORTC QLQ-CIPN20; Gynecologic Malignancy

Outcome Measures

Primary Outcomes (1)

• Incidence of Grade ≥2 Chemotherapy-Induced Peripheral Neuropathy (CIPN) in the Intervention vs. Control Hand

  Peripheral neuropathy severity will be assessed using the validated EORTC QLQ-CIPN20 questionnaire. The sensory subscale score ranges from 0 to 100, with higher scores indicating worse symptoms. A total score of ≥25 will be defined as grade 2 or higher neuropathy. Each patient will serve as their own control: the non-dominant hand will receive the surgical glove compression intervention, while the dominant hand will not. The difference in incidence of grade ≥2 neuropathy between the two hands will be evaluated. Unit of Measure: Percentage of patients with grade ≥2 neuropathy, defined as a sensory score ≥25 on the EORTC QLQ-CIPN20 (range 0-100; higher scores indicate worse symptoms).

  At Day 1 (baseline, prior to chemotherapy), Day 64 (after Cycle 3), and Day 127 (after Cycle 6); each chemotherapy cycle is 21 days.

Secondary Outcomes (4)

• Incidence of Grade ≥2 Chemotherapy-Induced Peripheral Neuropathy by Baseline Weight Loss Status

  From baseline (Day 1) to end of treatment (Day 127, after Cycle 6); each cycle is 21 days.

• Incidence of Grade ≥2 Chemotherapy-Induced Peripheral Neuropathy by ECOG Performance Status

  From baseline (Day 1) to end of treatment (Day 127, after Cycle 6); each cycle is 21 days.

• Change in EORTC QLQ-CIPN20 Sensory Score Over Time

  At Day 1 (baseline, prior to chemotherapy), Day 64 (after Cycle 3), and Day 127 (after Cycle 6); each chemotherapy cycle is 21 days.

• Change in Quality of Life Based on EORTC QLQ-C30 Global Health Status

  From baseline (Day 1) to end of treatment (Day 127, after Cycle 6); each cycle is 21 days.

Study Arms (1)

Single Cohort - Self-Controlled

EXPERIMENTAL

This arm includes female patients with gynecologic malignancies receiving paclitaxel-based chemotherapy. Each participant's non-dominant hand received the intervention of two tight-fitting surgical gloves (one size smaller than standard), while the dominant hand remained ungloved and served as an internal control. The gloves were worn during each paclitaxel infusion, starting 30 minutes before the infusion and removed 30 minutes after completion. Neuropathy was assessed using the EORTC QLQ-CIPN20 questionnaire at baseline, after cycle 3, and at the end of treatment. No additional clinical visits were scheduled outside of routine oncology care.

Device: Surgical Glove Compression

Interventions

Surgical Glove Compression DEVICE

Participants wore two tight-fitting surgical gloves (one size smaller than standard) on the non-dominant hand. The gloves were applied 30 minutes prior to each paclitaxel infusion, remained in place during the infusion, and were removed 30 minutes afterward. The dominant hand remained ungloved and served as an internal control. This intervention was entirely non-pharmacologic and was integrated into routine chemotherapy sessions.

Also known as: Physical Compression Using Tight-Fitting Gloves

Single Cohort - Self-Controlled

Eligibility Criteria

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

You may qualify if:

• Female patients aged ≥18 years
• Histologically confirmed gynecologic malignancy (e.g., ovarian, or endometrial cancer)
• Scheduled to receive carboplatin-paclitaxel chemotherapy administered every 21 days
• Planned for a total of six chemotherapy cycles
• ECOG performance status 0-2
• Ability to provide written informed consent

You may not qualify if:

• Patients receiving neoadjuvant chemotherapy with planned surgery
• Patients receiving weekly (dose-dense) paclitaxel regimens
• Prior exposure to neurotoxic chemotherapy agents (e.g., taxanes, platinum compounds, proteasome inhibitors, anti-tubulin agents)
• History of pre-existing peripheral neuropathy
• Known allergy to latex or surgical gloves
• Diagnosed peripheral vascular disease
• Concurrent use of medications that may mask or modulate neuropathy symptoms (e.g., gabapentinoids, SNRIs, vitamin B complex, alpha-lipoic acid)
• Clinical diagnosis of diabetic neuropathy or history of alcohol-related neuropathy
• Raynaud's phenomenon or other cold-sensitive vascular conditions
• Other neurological disorders that may interfere with neuropathy assessment
• Refusal or inability to provide informed consent

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Etlik City Hospital

Ankara, Yenimahalle, 06170, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Endometrial Neoplasms; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label study; no parties are masked.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncologist, Principal Investigator

Model Details: All participants receive the same intervention, consisting of tight-fitting surgical gloves worn on the non-dominant hand during paclitaxel infusion. The dominant hand serves as an internal control for each participant. This single-group, self-controlled design allows intra-individual comparison of neuropathy outcomes.

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: August 6, 2025
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: July 11, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)