Table 2.
Distribution of demographic and clinical characteristics.
| Control Arm (Placebo) N = 60 (%) |
Intervention Arm (PMA-Zeolite) N = 60 (%) |
p-Value * | |
|---|---|---|---|
| Sex | 0.46 | ||
| Male | 35 (58.3) | 31 (51.7) | |
| Female | 25 (41.7) | 29 (48.3) | |
| Age | 0.054 | ||
| <60 | 19 (31.7) | 30 (50.0) | |
| 61–65 | 13 (21.7) | 4 (6.7) | |
| 66–70 | 14 (23.3) | 15 (25.0) | |
| >70 | 14 (23.3) | 11 (18.3) | |
| BMI | 0.44 | ||
| <24.9 | 38 (63.3) | 34 (56.7) | |
| 25.0–29.9 | 17 (28.3) | 23 (38.3) | |
| ≥30.0 | 5 (8.3) | 3 (5.0) | |
| Type of cancer | 0.46 | ||
| Colorectal | 55 (91.7) | 57 (95.0) | |
| Other | 5 (8.3) | 3 (5.0) | |
| Chemotherapy scheme | 0.47 | ||
| Folfox | 51 (85.0) | 55 (91.7) | |
| Xelox | 8 (13.3) | 4 (6.7) | |
| Altro | 1 (1.7) | 1 (1.7) | |
| Chemotherapy line | (n = 60) | (n = 59) | 0.36 |
| Adjuvant | 24 (40.0) | 25 (42.4) | |
| First line | 30 (50.0) | 30 (50.8) | |
| Second Line | 3 (5.0) | 4 (6.8) | |
| Third Line | 3 (5.0) | 0 | |
| N. chemotherapy cycles received | 0.03 | ||
| ≤6 cycles | 17 (28.3) | 6 (10.0) | |
| 7–8 cycles | 9 (15.0) | 11 (18.3) | |
| >8 cycles | 34 (56.7) | 43 (71.7) | |
| Comorbidity | 0.017 | ||
| No | 21 (35.0) | 34 (56.7) | |
| Yes | 39 (65.0) | 26 (43.3) | |
| Suspension Chemotherapy | (n = 57) | (n = 59) | 0.96 |
| No | 54 (94.7) | 56 (94.9) | |
| Yes | 3 (5.3) | 3 (5.1) | |
| Reduction Oxaliplatin dose | (n = 57) | (n = 59) | 0.19 |
| No | 31 (54.4) | 25 (42.4) | |
| Yes | 26 (45.6) | 34 (57.6) | |
| Neurography 1 | (n = 56) | (n = 57) | 0.60 |
| (94.2% Response rate) | |||
| Normal | 42 (75.0) | 42 (73.7) | |
| Mild + Moderate | 14 (25.0) | 14 (24.6) | |
| Severe | 0 | 1 (1.8) | |
| Neurography 3 | (n = 34) | (n = 42) | 0.47 |
| (64% Response rate) | |||
| Normal | 10 (29.4) | 15 (35.7) | |
| Mild + Moderate | 23 (67.6) | 27 (64.3) | |
| Severe | 1 (2.9) | 0 | |
| Neurography 1 | (n = 56) | (n = 57) | 0.87 |
| No “Neurotox” | 42 (75.0) | 42 (73.7) | |
| Yes “Neurotox” | 14 (25.0) | 15 (26.3) | |
| Neurography 3 | (n = 34) | (n = 42) | 0.56 |
| No “Neurotox” | 10 (29.4) | 15 (35.7) | |
| Yes “Neurotox” | 24 (70.6) | 27 (64.3) |
* Chi-square test.