NCT06763575

Efficacy of Surgical Glove-Compression Therapy As a Prevention of Paclitaxel-Induced Peripheral Neuropathy

Efficacy of Surgical Glove-Compression Therapy As a Prevention of Paclitaxel-Induced Peripheral Neuropathy: Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Department of Medical Services Ministry of Public Health of Thailand · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this randomized controlled trial (RCT) is to compare the incidence of paclitaxel-induced grade 2 or higher sensory peripheral neuropathy, evaluated using the CTCAE version 5.0, between patients receiving surgical glove-compression therapy (SGCT) and those in the control group. The main question is whether SGCT is effective in preventing paclitaxel-induced sensory peripheral neuropathy. * Intervention group: receive SGCT. * Control group: receive non-compressive plastic gloves.

Detailed description

1. The study aims to test the hypothesis that SGCT is effective in preventing paclitaxel-induced peripheral neuropathy. 2. The primary objective is to determine the incidence of grade 2 or higher paclitaxel-induced sensory peripheral neuropathy, assessed using the CTCAE version 5.0. Secondary objectives include evaluating the incidence of grade 2 or higher paclitaxel-induced motor peripheral neuropathy using CTCAE version 5.0, the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) score, the incidence of grade D or higher paclitaxel-induced sensory and motor peripheral neuropathy as measured by the Patient Neurotoxicity Questionnaire (PNQ), and the outcomes from the monofilament test. 3. Sample size formula based on Bernard R. Fundamentals of biostatistics. 5th ed. Duxbery: Thomson learning; 2000. Enrollment of 36 patients. 4. Randomization into two groups. The intervention arm will receive SGCT, while the control arm will receive non-compressive plastic gloves. The duration of treatment is 9 weeks. 5. Enrollment and data monitoring are assessed by staff at the Oncology Unit, Rajavithi Hospital, and the data will be recorded in a computer-based information system. 6. Data assessment will be conducted on weeks 0, 3, 6, and 9 during the chemotherapy treatment. 7. Data analyzed by descriptive and inferential statistics.

Conditions

• Paclitaxel-induced Peripheral Neuropathy

Interventions

Type	Name	Description
DEVICE	Surgical Glove-Compression Therapy	In the intervention group, patients wore double-layered surgical gloves, one size smaller than measured, covered by large cotton gloves on both hands, for 30 minutes before, during, and after chemotherapy.
DEVICE	non-compressive plastic gloves	In the control group, patients wore non-compressive plastic gloves, covered by large cotton gloves on both hands, for 30 minutes before, during, and after chemotherapy.

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-01-01
• Completion: 2026-06-01
• First posted: 2025-01-08
• Last updated: 2025-01-08

Locations

1 site across 1 country: Thailand