Taxane-induced peripheral neuropathy (TIPN) caused by albumin-bound paclitaxel is a dose-limiting toxicity. The main symptoms of discomfort are numbness, tingling, and burning sensations in the glove-sock-like distribution of the limbs. At present, there are few effective methods for clinical treatment of TIPN, and there is no widely agreed consensus on effective treatment in the world. Therefore, it is of great clinical significance and practical value to carry out clinical research to explore drugs to relieve TIPN.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
The experimental group received 80 mg of monosialic gangliosides (GM1) on days -1, 1, and 2 of albumin-bound paclitaxel(GM1 is a single infusion).
The control group received placebo on days -1, 1, and 2 of albumin-bound paclitaxel (placebo as a single infusion)
Henan Cancer Hospital
Zhengzhou, Henan, China
FACT-Ntx score
The FACT-Ntx subscale includes 11 items, each of which is divided into 5 scoring levels: 0, 1, 2, 3, 4, and a total score of 44. Higher scores indicate lower side effects
Time frame: 2 weeks after chemotherapy
CTCAE Version 4.0 score
Peripheral sensory neuropathy, peripheral motor neuropathy, paresthesia, myalgia, arthralgia, and neuralgia were evaluated by the CTCAE 4.0 rating scale. Each item was divided into 5 levels: 1, 2, 3, 4, 5, Higher indicates higher neurotoxicity
Time frame: During chemotherapy, and 2 weeks, 3 months, 6 months, and 12 months after chemotherapy
FACT-Taxane score
The FACT-Taxane scale contains 16 items, each item is divided into 5 grades: 0, 1, 2, 3, 4, with a total score of 64. The higher the score, the lower the side effects.
Time frame: During chemotherapy, and 2 weeks, 3 months, 6 months, and 12 months after chemotherapy
FACT-G score
The FACT-G Scale contains 27 items, each item is divided into 5 grades: 0, 1, 2, 3, 4, with a total score of 108
Time frame: During chemotherapy, and 2 weeks, 3 months, 6 months, and 12 months after chemotherapy
FACT-Ntx score
The FACT-Ntx subscale includes 11 items, each of which is divided into 5 scoring levels: 0, 1, 2, 3, 4, and a total score of 44. Higher scores indicate lower side effects
Time frame: 3 months, 6 months, and 12 months after chemotherapy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.