Table 2 Population characteristics
Overall | Arm A (active LLLT/PBMT) (N = 42) | ArmB (placebo LLLT/PBMT) (N = 41) | p-value | ||
|---|---|---|---|---|---|
Gender | Female | 8 (9.6%) | 5 (11.9%) | 3 (7.3%) | 0.74 |
Male | 75 (90.4%) | 37 (88.1%) | 38 (92.7%) | ||
Age (years) | Mean ± SD | 58 (53–65) | 58 (53–62) | 58 (53–68) | 0.25 |
Tumour Location | Oral cavity | 17 (20.5%) | 9 (21.4%) | 8 (19.5%) | 0.70 |
Hypopharynx | 19 (22.9%) | 11 (26.2%) | 8 (19.5%) | ||
Oropharynx | 47 (56.6%) | 22 (52.4%) | 25 (61.0%) | ||
TNM classification | T1 | 7 | 3 (7.1%) | 4 (9.8%) | 0.09 |
T2 | 24 | 16 (38.1%) | 8 (19.5%) | ||
T3 | 34 | 16 (38.1%) | 18 (43.9%) | ||
T4a | 13 | 7 (16.7%) | 6 (14.6%) | ||
T4b | 5 | 0 (0%) | 5 (12.2%) | ||
N0 | 15 | 5 (11.9%) | 10 (24.4%) | 0.36 | |
N1 | 6 | 2 (4.8%) | 4 (9.8%) | ||
N2 | 56 | 31 (73.8%) | 25 (61.0%) | ||
N3 | 5 | 3 (7.1%) | 2 (4.9%) | ||
Nx | 1 | 1 (2.4%) | 0 (0%) | ||
M0 | 83 (100%) | 42 (100%) | 41 (100%) | ||
Histologic differentiation | Well-differentiated | 36 (43.4%) | 17 (40.5%) | 19 (46.3%) | 0.25 |
Unknown | 6 (7.2%) | 4 (9.5%) | 2 (4.9%) | ||
Moderately differentiated | 31 (37.3%) | 18 (42.9%) | 13 (31.7%) | ||
Poorly differentiated | 10 (12.0%) | 3 (7.1%) | 7 (17.1%) | ||
Smoking status | Never-smokers | 12 (14.5%) | 3 (7.1%) | 9 (22%) | 0.11 |
Smokers | 71 (85.5%) | 39 (92.9%) | 32 (78%) | ||
During CRT | Smoking cessation | 8 (11.3%) | 4 (10.3%) | 4 (12.5%) | 0.95 |
Active smokers | 23 (32.4%) | 13 (33.3%) | 10 (31.3%) | ||
Unspecified | 40 (56.3%) | 22 (56.4%) | 18 (56.3%) | ||
Alcohol consumption | No | 22 (26.5%) | 11 (26.2%) | 11 (26.8%) | 0.92 |
Unknown | 3 (3.6%) | 1 (2.4%) | 2 (4.9%) | ||
Yes | 58 (69.9%) | 30 (71.4%) | 28 (68.3%) | ||
During CRT | Alcohol withdrawal | 8 (13.8%) | 3 (10.0%) | 5 (17.9%) | 0.72 |
Active alcohol use | 21 (36.2%) | 11 (36.7%) | 10 (35.7%) | ||
Unspecified | 29 (50.0%) | 16 (53.3%) | 13 (46.4%) | ||
Feeding | Enteral feeding | 9 (10.8%) | 3 (7.1%) | 6 (14.6%) | 0.39 |
Liquid diet | 1 (1.2%) | 1 (2.4%) | 0 (0%) | (0.64 with binary data) | |
Minced food | 23 (27.7%) | 13 (31%) | 10 (24.4%) | ||
Unspecified | 2 (2.4%) | 0 (0%) | 2 (4.9%) | ||
Solid diet | 48 (57.8%) | 25 (59.5%) | 23 (56.1%) |