Table 1.
Patient Demographic and Clinical Characteristics
| Characteristic | ALC (n = 208) |
Placebo (n = 201) |
||
|---|---|---|---|---|
| No. | % | No. | % | |
| Age, years | ||||
| Median | 52 | 50 | ||
| Range | 27-80 | 26-77 | ||
| < 60 | 149 | 72 | 143 | 71 |
| ≥ 60 | 59 | 28 | 58 | 29 |
| Hispanic | ||||
| Yes | 21 | 10 | 15 | 7 |
| No | 181 | 87 | 177 | 88 |
| Unknown | 6 | 3 | 9 | 4 |
| Race | ||||
| White | 160 | 77 | 165 | 82 |
| Black | 17 | 8 | 20 | 10 |
| Asian | 12 | 6 | 8 | 4 |
| Pacific Islander | 4 | 2 | 2 | 1 |
| Native American | 1 | 0 | 0 | 0 |
| Multiracial | 2 | 1 | 1 | 0 |
| Unknown | 12 | 6 | 5 | 2 |
| Treatment | ||||
| Paclitaxel once per week, 12 cycles | 73 | 35 | 68 | 34 |
| Paclitaxel every 2 weeks for four cycles | 48 | 23 | 51 | 25 |
| Paclitaxel every 2 weeks for six cycles | 3 | 1 | 5 | 2 |
| Docetaxel every 3 weeks for four cycles | 51 | 25 | 48 | 24 |
| Docetaxel every 3 weeks for six cycles | 33 | 16 | 29 | 14 |
| Performance status | ||||
| 0 | 156 | 75 | 146 | 73 |
| 1 | 51 | 25 | 54 | 27 |
| 2 | 1 | < 1 | 1 | < 1 |
| Breast cancer stage | ||||
| I | 57 | 27 | 50 | 25 |
| II | 110 | 53 | 107 | 54 |
| III | 41 | 20 | 43 | 21 |
| Serum carnitine level, ng/mL* | ||||
| Baseline† | ||||
| Mean | 5,562 | 5,447 | ||
| SD | 2,525 | 2,005 | ||
| 12 weeks‡ | ||||
| Mean | 7,176 | 5,493 | ||
| SD | 2,104 | 2,224 | ||
Abbreviations: ALC, acetyl-L-carnitine; SD, standard deviation.
*
Sample size (n = 206) with both baseline and week-12 carnitine scores (ALC, n = 108; placebo, n = 98).
†
Difference between baseline and 12-week carnitine level in ALC group (P < .001).
‡
Difference between 12-week carnitine level in ALC and placebo groups (P < .001).