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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDepartment of Medical Services Ministry of Public Health of Thailand

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Surgical Glove-Compression TherapyExperimental treatment 1 intervention
Group B: non-compressive plastic glovesPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
9 weeks

Secondary outcomes

1

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.

Time frame
9 weeks
2

FACT/GOG-NTX scores

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

Time frame
9 weeks
3

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.

Time frame
9 weeks
4

Monofilament test results

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

Time frame
9 weeks

Other outcomes

Sponsors and contacts

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