Clinical trial · Interventional
Glove Compression for Chemotherapy-Induced Neuropathy
Neuro Glove: A Prospective Self-Controlled Study of Glove Compression as a Protective Strategy Against Chemotherapy-Induced Peripheral Neuropathy in Women With Gynecologic Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-induced Peripheral Neuropathy (CIPN) | — | UNRESOLVED | — |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Gynecologic Cancers | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer (OvCa) | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surgical Glove Compression | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Cohort - Self-Controlled
- description
- 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.
- interventionNames
- Device: Surgical Glove Compression
Primary outcomes (1)
- measure
- Incidence of Grade ≥2 Chemotherapy-Induced Peripheral Neuropathy (CIPN) in the Intervention vs. Control Hand
- timeFrame
- At Day 1 (baseline, prior to chemotherapy), Day 64 (after Cycle 3), and Day 127 (after Cycle 6); each chemotherapy cycle is 21 days.
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBaskurt K, Uyar GC, Yesilbas E, Altunc FZ, Cevik DE, Melek IM, Eren Y, Oksuzoglu OBC, Yucel KB, Di Meglio A, Ray-Coquard I, Sutcuoglu O. Limb Compression Therapy and Chemotherapy-Induced Peripheral Neuropathy in Women With Gynecologic Cancers: A Prospective Self-Controlled Study(NEURO-GLOVE Trial). Int J Cancer. 2026 Jun 18. doi: 10.1002/ijc.70601. Online ahead of print. PMID 42311202