Glove Compression for Chemotherapy-Induced Neuropathy

NCT ID: NCT07105553

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-07-11

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.

Detailed Description

Chemotherapy-induced peripheral neuropathy (CIPN) is a common, dose-limiting, and often persistent adverse effect of taxane-based chemotherapy, particularly in women with gynecologic malignancies. CIPN significantly impairs quality of life and may necessitate chemotherapy dose reductions or discontinuation. Despite its clinical relevance, no pharmacologic agent has been proven to prevent CIPN. Accordingly, non-pharmacologic strategies such as physical compression have gained attention as potential neuroprotective interventions.

This prospective, non-randomized, self-controlled observational study is being conducted at Etlik City Hospital, Ankara, Türkiye. A total of seventy-six female patients aged 18 years or older with histologically confirmed gynecologic cancers (endometrial and ovarian) scheduled to receive six cycles of carboplatin-paclitaxel chemotherapy was enrolled. The intervention involves applying two tight-fitting surgical gloves (one size smaller than standard) to the non-dominant hand starting 30 minutes before each paclitaxel infusion, worn throughout the infusion, and removed 30 minutes afterward. The dominant hand, without compression, serves as an internal control.

Peripheral neuropathy symptoms are assessed using the EORTC QLQ-CIPN20 questionnaire, a validated tool developed by the European Organisation for Research and Treatment of Cancer. The Turkish version has been previously validated. The CIPN20 includes twenty items scored on a 1 (not at all) to 4 (very much) Likert scale, yielding a total score range from 20 to 80. CIPN20 assessments are conducted at baseline (prior to treatment), after cycle three, and after cycle six. Neurological consultation and electromyography (EMG) are performed only in patients reporting significant neuropathic symptoms and if clinically indicated.

All data collection occurs during routine clinical visits. The study remains entirely non-interventional and is integrated into standard oncology care without additional diagnostic or procedural burdens to participants. The primary objective is to evaluate the feasibility and potential role of glove compression in mitigating CIPN development in the intervention hand compared to the control hand, using validated patient-reported outcome measures.

Conditions

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

Study Design

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

Study Groups

Single Cohort - Self-Controlled

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.

Group Type: EXPERIMENTAL

Surgical Glove Compression

Intervention Type: 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.

Interventions

Surgical Glove Compression

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.

Intervention Type: DEVICE

Other Intervention Names

Physical Compression Using Tight-Fitting Gloves

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

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

Sponsors

Ankara Etlik City Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Galip Can Uyar

Medical Oncologist, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Etlik City Hospital

Ankara, Yenimahalle, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AEŞH-EK1-2023-828

Identifier Type: REGISTRY

Identifier Source: secondary_id

AEŞH-EK1-2023-828

Identifier Type: -

Identifier Source: org_study_id