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

Not Applicable

Recruiting

• Conditions: Paclitaxel-induced Peripheral Neuropathy

• Registration Number: NCT06763575
• Lead Sponsor: Rajavithi Hospital

Brief 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.

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-01
• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-02
• Last Update Submitted: 2025-01-02
• Study First Posted: 2025-01-08
• Last Update Posted: 2025-01-08
• Primary Completion: 2026-01-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Signed Informed Consent Form
• Age 18 years or older at the time of signing Informed Consent Form
• Patients with any pathological diagnosis of solid tumor, such as breast cancer or lung cancer
• Patients scheduled to be receiving intravenous paclitaxel or paclitaxel-based regimen every 3 weeks

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Exclusion Criteria

• Patients whose received chemotherapeutic agents that could cause neuropathy, e.g. taxane-based or platinum-based chemotherapy and anti-microtubule
• History of neuropathy
• History of carpal tunnel syndrome
• History of allergic reactions to latex or gloves
• Patients receiving treatments that may treat neuropathy, e.g. amitriptyline, gabapentin, Acetyl L-Carnitine and Ganglioside-monosialic acid, acupuncture, cryotherapy or exercise therapy
• History of Raynaud phenomenon
• History of wounds or large scars on hands
• Pregnancy or breastfeeding
• History of poorly controlled diabetes; HbA1c>6.5

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of grade 2 or higher paclitaxel-induced sensory peripheral neuropathy using CTCAE version 5.0.	9 weeks	The incidence of grade 2 or higher paclitaxel-induced sensory peripheral neuropathy was evaluated using the CTCAE version 5.0 for both the intervention and control groups.

Secondary Outcome Measures

Name	Time	Method
Incidence of grade 2 or higher paclitaxel-induced motor peripheral neuropathy using CTCAE versions 5.0	9 weeks	The incidence of grade 2 or higher paclitaxel-induced motor peripheral neuropathy was evaluated using the CTCAE version 5.0 in both the intervention and the control groups.
FACT/GOG-NTX scores	9 weeks	FACT/GOG-NTX scores in both the intervention and the control group.
Incidence of grade D or higher paclitaxel-induced sensory and motor peripheral neuropathy using the PNQ	9 weeks	The incidence of grade D or higher paclitaxel-induced sensory and motor peripheral neuropathy using the PNQ in both the intervention and the control group.
Monofilament test results	9 weeks	Monofilament test results in both the intervention and the control group.

Trial Locations

Locations (1)

Rajavithi Hospital, Medical Oncology Unit; 🇹🇭 Bangkok, Thailand