Table 1.
Demographics and baseline characteristics.
| TTX Dosage | |||||
|---|---|---|---|---|---|
| Variable | 7.5 µg BID (N = 25) |
15 µg BID (N = 24) |
30 µg QD (N = 25) |
30 µg BID (N = 26) |
Placebo (N = 25) |
| Age, mean (±SD), y | 59.1 (±10.3) | 61.4 (±10.0) | 60.4 (±10.3) | 60.6 (±11.1) | 59.0 (±10.3) |
| Female, n (%) | 16 (64.0) | 15 (62.5) | 15 (60.0) | 16 (61.5) | 15 (60.0) |
| BMI, mean (±SD), kg m−2 | 30.6 (±6.4) | 28.6 (±6.5) | 30.1 (±7.8) | 30.1 (±7.9) | 32.6 (±10.0) |
| Baseline NPRS, mean ±SD | 6.3 (±1.3) | 7.0 (±1.4) | 6.2 (±1.2) | 6.3 (±1.4) | 6.7 (±1.5) |
| CINP Duration, Mean (±SD), y | |||||
| Lower extremities | 3.4 (±5.4) | 2.1 (±2.3) | 1.7 (±2.1) | 2.4 (±1.9) | 3.1 (±3.1) |
| Upper extremities | 3.5 (±5.6) | 1.8 (±1.8) | 1.9 (±2.2) | 2.4 (±2.0) | 2.7 (±2.9) |
| Prior Medications | |||||
| Opiates, n (%) a | 7 (28.0) | 7 (29.2) | 8 (32.0) | 6 (23.1) | 9 (29.6) |
| SNRI, n (%) | 2 (8.0) | 2 (8.3) | 5 (20.0) | 4 (15.4) | 4 (16.0) |
| Anticonvulsants, n (%) b | 9 (36.0) | 8 (33.3) | 4 (16.0) | 10 (38.5) | 4 (16.0) |
| NSAIDs, n (%) c | 5 (20.0) | 7 (29.2) | 2 (8.0) | 3 (11.5) | 5 (20.0) |
| Prior radiation, n (%) | 13 (52.0) | 10 (41.7) | 13 (52.0) | 14 (53.8) | 11 (44.0) |
| Primary Cancer, n (%) | |||||
| Colon | 10 (40.0) | 7 (29.2) | 7 (28.0) | 8 (30.8) | 12 (48.0) |
| Breast | 9 (36.0) | 6 (25.0) | 9 (36.0) | 10 (38.5) | 5 (20.0) |
| Other | 6 (24.0) | 11 (45.8) | 9 (36.0) | 8 (30.8) | 8 (32.0) |
| Chemotherapy Considered to Cause Pain, n d | |||||
| Taxane | 7 | 10 | 12 | 11 | 6 |
| Platinum | 19 | 16 | 15 | 16 | 19 |
BMI: body mass index; CINP: chemotherapy induced neuropathic pain; NPRS: Numerical Pain Rating Scale; NSAIDs: non-steroidal anti-inflammatory drugs; SNRI: selective norepinephrine reuptake inhibitor; TTX: tetrodotoxin; BID: twice daily; QD: once daily; n: number of subjects. a Natural opium alkaloids. b Gabapentin, pregabalin, topiramate. c Propionic acid derivatives. d Taxane and platinum were both counted in some patients.