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NCT Number: NCT06763575

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rajavithi Hospital, Medical Oncology Unit

Bangkok, 10400, Thailand

Location status: Recruiting

Location contact

Kunlatida Maneenil, M.D.

CONTACT

Piyawan Tienchaiananda, M.D.

CONTACT

Saowani Thantaviraya, M.D.

CONTACT

[email protected]

+668-05564241

Saowani Thantaviraya, M.D.

CONTACT

Songwit Payapwattanawong, M.D.

CONTACT

Sunatee Sa-nguansai, M.D.

CONTACT

[email protected]

+66896949358

About this study

  • The study aims to test the hypothesis that SGCT is effective in preventing paclitaxel-induced peripheral neuropathy.
  • 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.
  • Sample size formula based on Bernard R. Fundamentals of biostatistics. 5th ed. Duxbery: Thomson learning; 2000. Enrollment of 36 patients.
  • 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.
  • 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.
  • Data assessment will be conducted on weeks 0, 3, 6, and 9 during the chemotherapy treatment.
  • Data analyzed by descriptive and inferential statistics.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Incidence of grade 2 or higher paclitaxel-induced sensory peripheral neuropathy using CTCAE version 5.0.

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. FACT/GOG-NTX scores

    Time frame: 9 weeks

    FACT/GOG-NTX scores in both the intervention and the control group.

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

    Time frame: 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.

  4. Monofilament test results

    Time frame: 9 weeks

    Monofilament test results in both the intervention and the control group.

Study contacts

Contact information is provided by the study sponsor or research team.

Saowani Thantaviraya, M.D.

CONTACT

[email protected]

+66805564241

Sunatee Sa-nguansai, M.D.

CONTACT

[email protected]

+66896949358

Sponsors and collaborators

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 8, 2025
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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