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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Surgical Glove-Compression Therapy
DeviceIn 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
DeviceIn 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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
FACT/GOG-NTX scores
FACT/GOG-NTX scores in both the intervention and the control group.
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.
Monofilament test results
Monofilament test results in both the intervention and the control group.
Sponsors and contacts
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