RecruitingNot ApplicableNCT06763575

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


Sponsor

Department of Medical Services Ministry of Public Health of Thailand

Enrollment

36 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria9

  • 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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Interventions

DEVICESurgical 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.

DEVICEnon-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.


Locations(1)

Rajavithi Hospital, Medical Oncology Unit

Bangkok, Bangkok, Thailand

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NCT06763575