Study | study design | Type of malignancy | Chemotherapy regimen | Participants | GM1 regimen | Controls | Mean cumulative dose of chemotherapy (GM1 vs. control) | Endpoints | Study Duration | |||
---|---|---|---|---|---|---|---|---|---|---|---|---|
age, yr (mean/median) | age range | GM1 | Control | |||||||||
Chen et al., 2012 | Retrospective | colorectal cancer | mFOLFOX6, FOLFOX4, XELOX | 53.5 (median) | 36–75 | 114 | 164 | 40 mg*4/cycle | None | oxaliplatin, 1120 vs. 960 mg/m2 | CIPN (CTCAE); RECIST; CD | 24.6 months follow-up |
Zhu et al., 2013 | RCT | gastrointestinal cancer | FOLFOX4, XELOX | 54.96 (mean) | 21–74 | 60 | 60 | 100 mg*3/cycle | None | oxaliplatin, 692.08 vs. 740.83 mg/m2 | CIPN (CTCAE); RECIST | over 3 months after chemotherapy |
Cao et al., 2014 | RCT | gastrointestinal cancer | FOLFOX6, XELOX | 56 (median) | 31–72 | 38 | 30 | 40 mg*3/cycle | Vitamin B12 | NR | CIPN (DEB-NTC); RECIST; AEs | >12w |
Su et al., 2020 (NCT02468739) | RCT (multicenter) | breast cancer | EC-P, EC-D, DC | 44.5 (median) | 23–74 | 103 | 103 | 80 mg*3/cycle | Placebo | paclitaxel, 942.67 vs. 954.29 mg/m2; Docetaxel, 525.31 vs. 501.81 mg/m2 | CIPN (CTCAE); AEs | 12 months after completion of chemotherapy |
Wang et al., 2020 (NCT02251977) | RCT (multicenter) | colorectal cancer | mFOLFOX6, XELOX | 52.6 (mean) | >  18 | 98 | 98 | 80 mg*5/cycle | Placebo | NR | CIPN (CTCAE, DEB-NTC); AEs; CD | 48 months after chemotherapy |