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

NCT06763575 | Recruiting DMC

• 1 other identifier: 67171
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Paclitaxel-induced Peripheral Neuropathy

Keywords

Paclitaxel; Surgical Glove-Compression Therapy; Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Incidence of grade 2 or higher paclitaxel-induced motor peripheral neuropathy using CTCAE versions 5.0

  9 weeks

• FACT/GOG-NTX scores

  9 weeks

• Incidence of grade D or higher paclitaxel-induced sensory and motor peripheral neuropathy using the PNQ

  9 weeks

• Monofilament test results

  9 weeks

Study Arms (2)

Surgical Glove-Compression Therapy

EXPERIMENTAL

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

non-compressive plastic gloves

PLACEBO COMPARATOR

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

Interventions

Surgical Glove-Compression Therapy DEVICE

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.

Surgical Glove-Compression Therapy

non-compressive plastic gloves DEVICE

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.

non-compressive plastic gloves

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (1)

Rajavithi Hospital, Medical Oncology Unit

Bangkok, Bangkok, 10400, Thailand

RECRUITING

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Sunatee Sa-nguansai, M.D.

  Department of Medical Services Ministry of Public Health of Thailand

  STUDY DIRECTOR

• Saowani Thantaviraya, M.D.

  Department of Medical Services Ministry of Public Health of Thailand

  PRINCIPAL INVESTIGATOR

• Kunlatida Maneenil, M.D.

  Department of Medical Services Ministry of Public Health of Thailand

  PRINCIPAL INVESTIGATOR

• Piyawan Tienchaiananda, M.D.

  Department of Medical Services Ministry of Public Health of Thailand

  PRINCIPAL INVESTIGATOR

• Songwit Payapwattanawong, M.D.

  Department of Medical Services Ministry of Public Health of Thailand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saowani Thantaviraya, M.D.

CONTACT

+66805564241; saowani.mook@gmail.com

Sunatee Sa-nguansai, M.D.

CONTACT

+66896949358; sunatee@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 8, 2025
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: December 2024 - December 2025

Locations

TH (1)