Nanoparticle albumin-bound paclitaxel has greater efficacy and favorable safety profile than standard paclitaxel. However, rate of neuropathy caused by nanoparticle albumin-bound paclitaxel is higher than standard paclitaxel, and is one of its dose-limited toxicities. Previously, compression therapy by surgical gloves has shown effectiveness in preventing chemotherapy-induced neuropathy. We designed this multi-center prospective self-control phase III study to investigate the efficacy of compression gloves to reduce albumin-binding paclitaxel induced sensory and motor neurotoxicity of upper extremities.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
70
Patients wear small-size compression gloves (one or two size smaller than suitable size) for dominant hands and suitable-size compression gloves for non-dominant hands for 90 minutes during the administration of albumin-binding paclitaxel (start from 30 minutes before albumin-binding paclitaxel infusion).
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGDifferences in severe peripheral sensory neurotoxicity rates
Differences in peripheral sensory neurotoxicity (NCI-CTCAE Grade 2-5) rates between dominant hands and non-dominant hands after 4 cycles of albumin-binding paclitaxel monotherapy.
Time frame: 3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days).
Differences in total peripheral sensory neurotoxicity rates
Differences in total peripheral sensory neurotoxicity (NCI-CTCAE Grade 1-5) rates between dominant hands and non-dominant hands after 4 cycles of albumin-binding paclitaxel monotherapy.
Time frame: 3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days).
Differences in severe peripheral motor neurotoxicity rates
Differences in severe peripheral motor neurotoxicity (NCI-CTCAE Grade 2-5) rates between dominant hands and non-dominant hands after 4 cycles of albumin-binding paclitaxel monotherapy.
Time frame: 3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days).
Differences in total peripheral motor neurotoxicity rates
Differences in total peripheral motor neurotoxicity (NCI-CTCAE Grade 1-5) rates between dominant hands and non-dominant hands after 4 cycles of albumin-binding paclitaxel monotherapy.
Time frame: 3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days).
Differences in peripheral neurotoxicity questionaire scores
Differences in peripheral neurotoxicity questionaire scores between dominant hands and non-dominant hands after 4 cycles of albumin-binding paclitaxel monotherapy.
Time frame: 3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days).
Safety of compression gloves in preventing albumin-binding paclitaxel induced neurotoxicity.
Adverse events related to compression gloves intervention are collected.
Time frame: From date of consent to one months after Cycle 4 administration of albumin-binding paclitaxel (each cycle is 21 days).
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