Table 1.
Baseline Patient Characteristics
| Characteristic | CaMg Before and After Chemotherapy (n = 118) |
CaMg Before and Placebo After Chemotherapy (n = 116) |
Placebo (n = 119) |
Total (n = 353) |
P | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No. | % | Mean | SD | Median | No. | % | Mean | SD | Median | No. | % | Mean | SD | Median | No. | % | Mean | SD | Median | ||
| Age, years | 57.0 | 57.0 | 56.0 | 56.0 | .9058* | ||||||||||||||||
| Age group < 65 years | 88 | 75 | 87 | 75 | 90 | 76 | 265 | 75 | .9823† | ||||||||||||
| Male sex | 56 | 48 | 56 | 48 | 57 | 48 | 169 | 48 | .9922† | ||||||||||||
| Race/ethnicity | .4543‡ | ||||||||||||||||||||
| White | 96 | 81 | 99 | 85 | 105 | 88 | 300 | 85 | |||||||||||||
| Black or African American | 16 | 14 | 15 | 13 | 10 | 8 | 41 | 12 | |||||||||||||
| Asian | 4 | 3 | 1 | 1 | 2 | 2 | 7 | 2 | |||||||||||||
| American Indian or Alaska Native | 2 | 2 | 0 | 0 | 1 | 1 | 3 | 1 | |||||||||||||
| Not reported (patient refused or not available) | 0 | 0 | 1 | 1 | 1 | 1 | 2 | 1 | |||||||||||||
| Stage | .9627† | ||||||||||||||||||||
| II | 22 | 19 | 22 | 19 | 22 | 19 | 66 | 19 | |||||||||||||
| III | 89 | 75 | 88 | 76 | 88 | 74 | 265 | 75 | |||||||||||||
| IV | 7 | 6 | 6 | 5 | 9 | 8 | 22 | 6 | |||||||||||||
| Regimen | .9394† | ||||||||||||||||||||
| FOLFOX4 | 7 | 6 | 8 | 7 | 9 | 8 | 24 | 7 | |||||||||||||
| mFOLFOX6 | 111 | 94 | 108 | 93 | 110 | 92 | 329 | 93 | |||||||||||||
| Oral CaMg supplement | .9709† | ||||||||||||||||||||
| Missing | 2 | 0 | 3 | 5 | |||||||||||||||||
| Yes | 12 | 10 | 13 | 11 | 13 | 11 | 38 | 11 | |||||||||||||
| No | 104 | 90 | 103 | 89 | 103 | 89 | 310 | 89 | |||||||||||||
| Total EORTC QLQ-CIPN20 score | |||||||||||||||||||||
| Sensory neuropathy | 98.4 | 4.0 | 100.0 | 97.6 | 5.9 | 100.0 | 97.8 | 6.4 | 100.0 | 97.9 | 5.5 | 100.0 | .2654* | ||||||||
| Autonomic neuropathy | 95.0 | 10.1 | 100.0 | 92.3 | 12.6 | 100.0 | 91.8 | 13.0 | 100.0 | 93.0 | 12.0 | 100.0 | .1155* | ||||||||
| Motor neuropathy | 97.9 | 3.9 | 100.0 | 97.0 | 7.7 | 100.0 | 98.0 | 3.9 | 100.0 | 97.6 | 5.5 | 100.0 | .9789* | ||||||||
| Sensitivity to touching cold items | 95.9 | 14.2 | 100.0 | 94.4 | 17.0 | 100.0 | 96.0 | 14.5 | 100.0 | 95.4 | 15.3 | 100.0 | .3876* | ||||||||
| Discomfort swallowing cold liquids | 96.2 | 13.4 | 100.0 | 92.6 | 18.9 | 100.0 | 94.2 | 17.7 | 100.0 | 94.4 | 16.8 | 100.0 | .1173* | ||||||||
| Throat discomfort | 97.1 | 11.1 | 100.0 | 93.7 | 17.5 | 100.0 | 96.0 | 13.4 | 100.0 | 95.6 | 14.3 | 100.0 | .2685* | ||||||||
| Muscle cramps | 97.9 | 8.6 | 100.0 | 97.5 | 8.9 | 100.0 | 96.8 | 11.4 | 100.0 | 97.4 | 9.7 | 100.0 | .5322* | ||||||||
| Difficulties buttoning/tying | 99.7 | 2.1 | 100.0 | 98.8 | 5.9 | 100.0 | 99.8 | 1.3 | 100.0 | 99.5 | 3.7 | 100.0 | .0930* | ||||||||
Abbreviations: CaMg, calcium and magnesium; EORTC QLQ-CIPN20, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20; FOLFOX4, fluorouracil, leucovorin, and oxaliplatin; mFOLFOX6, modified fluorouracil, leucovorin, and oxaliplatin; SD, standard deviation.
Kruskal-Wallis test.
χ2 test.
Fisher's exact test.