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

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.

Study Overview

• Status: Recruiting
• Conditions: Paclitaxel-induced Peripheral Neuropathy
• Intervention / Treatment: Device: Surgical Glove-Compression Therapy; Device: 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 Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Saowani Thantaviraya, M.D.; Phone Number: +66805564241; Email: saowani.mook@gmail.com
• Study Contact Backup: Name: Sunatee Sa-nguansai, M.D.; Phone Number: +66896949358; Email: sunatee@hotmail.com

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Recruiting
    • Rajavithi Hospital, Medical Oncology Unit
    • Contact: Sunatee Sa-nguansai, M.D.; Phone Number: +66896949358; Email: sunatee@hotmail.com
    • Contact: Saowani Thantaviraya, M.D.; Phone Number: +668-05564241; Email: saowani.mook@gmail.com
    • Contact: Kunlatida Maneenil, M.D.
    • Contact: Piyawan Tienchaiananda, M.D.
    • Contact: Songwit Payapwattanawong, M.D.
    • Contact: Saowani Thantaviraya, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surgical Glove-Compression Therapy; 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: 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.
Placebo Comparator: non-compressive plastic gloves; Patients wore non-compressive plastic gloves, 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of grade 2 or higher paclitaxel-induced sensory peripheral neuropathy using CTCAE version 5.0.	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.	9 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of grade 2 or higher paclitaxel-induced motor peripheral neuropathy using CTCAE versions 5.0	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.	9 weeks
FACT/GOG-NTX scores	FACT/GOG-NTX scores in both the intervention and the control group.	9 weeks
Incidence of grade D or higher paclitaxel-induced sensory and motor peripheral neuropathy using the PNQ	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.	9 weeks
Monofilament test results	Monofilament test results in both the intervention and the control group.	9 weeks

Collaborators and Investigators

• Sponsor: Rajavithi Hospital
• Investigators: Study Director: Sunatee Sa-nguansai, M.D., Rajavithi Hospital; Principal Investigator: Saowani Thantaviraya, M.D., Rajavithi Hospital; Principal Investigator: Kunlatida Maneenil, M.D., Rajavithi Hospital; Principal Investigator: Piyawan Tienchaiananda, M.D., Rajavithi Hospital; Principal Investigator: Songwit Payapwattanawong, M.D., Rajavithi Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 2, 2025
• First Submitted That Met QC Criteria: January 2, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 2, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Paclitaxel; Peripheral Neuropathy; Surgical Glove-Compression Therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: 67171

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: December 2024 - December 2025
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No