Intention-to-treat | Per-protocol | |||||
---|---|---|---|---|---|---|
All N = 41 | IG vs. CG P | IG N = 18 | CG N = 19 | All N = 37 | IG vs. CG P | |
Age | ||||||
median (range) | 62 (44 – 82) | 0.025 | 70 (44 – 82) | 60 (46 – 75) | 63 (44 – 82) | 0.026 |
Sex | ||||||
m:f N (%) | 11 (27): 30 (73) | 4 (22): 14 (78) | 7 (37): 12 (63) | 11 (30): 26 (70) | ||
BMI | ||||||
median (range) | 25 (19 – 42) | 0.375 | 25 (19 – 42) | 24 (21 – 31) | 24 (19 – 42) | 0.425 |
Diagnosis N (%) | ||||||
Breast cancer | 14 (34) | 8 (44) | 4 (21) | 12 (32) | ||
Colorectal cancer | 14 (34) | 3 (17) | 10 (53) | 13 (35) | ||
Gynecological cancer other than breast | 4 (10) | 2 (11) | 1 (5) | 3 (8) | ||
Upper gastrointestinal cancer | 2 (5) | 1 (6) | 1 (5) | 2 (5) | ||
Non-small cell lung cancer | 1 (2) | 0 (0) | 1 (5) | 1 (3) | ||
Non-Hodgkin’s lymphoma | 5 (12) | 4 (22) | 1 (5) | 5 (14) | ||
Multiple myeloma | 1 (2) | 0 (0) | 1 (5) | 1 (3) | ||
Therapies N (%) | ||||||
Surgery | 38 (93) | 16 (89) | 18 (95) | 34 (92) | ||
Radiation | 15 (37) | 8 (44) | 5 (26) | 13 (35) | ||
Hematopoietic cell transplantation | 2 (5) | 1 (6) | 1 (5) | 2 (5) | ||
Chemotherapy | 41 (100) | 18 (100) | 19 (100) | 37 (100) | ||
N cycles, median (range) | 6 (1 – 18) | 0.681 | 6 (2 – 6) | 6 (2 – 16) | 6 (2 – 16) | 0.775 |
N neurotoxic agents, median (range) | 2 (1 – 4) | 0.115 | 2 (1 – 4) | 1 (1 – 4) | 2 (1 – 4) | 0.061 |
Therapy-free weeks, median (range) | 11 (1 – 167) | 0.754 | 10 (1 – 167) | 18 (3 – 98) | 13 (1 – 167) | 0.775 |
CIPN symptoms N (%) | ||||||
Reduced vibration sense* | 28 (70) | 13 (77) | 13 (68) | 26 (72) | ||
Reduced joint position sense# | 11 (28) | 5 (29) | 6 (32) | 11 (31) | ||
Reduced temperature sensation† | 23 (58) | 12 (71) | 10 (53) | 20 (56) | ||
Reduced pain sensation† | 4 (10) | 2 (12) | 2 (11) | 4 (11) | ||
Loss of reflexes ASR / PSR | 28 (68) / 8 (20) | 12 (67) / 3 (17) | 13 (68) / 3 (16) | 25 (68) / 6 (16) | ||
Compliance %, median (range) | 92 (25 – 100) | 0.175 | 92 (71 – 100) | 100 (71 – 100) | 96 (71 – 100) | 0.118 |