Table 3.
Patient Demographics at Baseline
| Characteristic | Overall (N=168) |
NMES (N=116) |
Sham (N=52) |
p-value |
|---|---|---|---|---|
| Site | ||||
| 1 | 28 (16.7%) | 19 (16.4%) | 9 (17.3%) | |
| 3 | 17 (10.1%) | 12 (10.3%) | 5 (9.6%) | |
| 4 | 16 (9.5%) | 11 (9.5%) | 5 (9.6%) | |
| 7 | 11 (6.5%) | 7 (6%) | 4 (7.7%) | |
| 8 | 2 (1.2%) | 1 (0.9%) | 1 (1.9%) | |
| 9 | 9 (5.4%) | 6 (5.2%) | 3 (5.8%) | |
| 11 | 9 (5.4%) | 7 (6%) | 2 (3.8%) | |
| 14 | 29 (17.3%) | 19 (16.4%) | 10 (19.2%) | |
| 15 | 7 (4.2%) | 5 (4.3%) | 2 (3.8%) | |
| 18 | 10 (6%) | 7 (6%) | 3 (5.8%) | |
| 19 | 4 (2.4%) | 3 (2.6%) | 1 (1.9%) | |
| 20 | 4 (2.4%) | 4 (3.4%) | 0 (0.0%) | |
| 21 | 3 (1.8%) | 2 (1.7%) | 1 (1.9%) | |
| 22 | 4 (2.4%) | 3 (2.6%) | 1 (1.9%) | |
| 24 | 1 (0.6%) | 1 (0.9%) | 0 (0.0%) | |
| 91 | 14 (8.3%) | 9 (7.8%) | 5 (9.6%) | |
| Gender | ||||
| Male | 144 (85.7%) | 100 (86.2%) | 44 (84.6%) | 0.814 |
| Female | 24 (14.3%) | 16 (13.8%) | 8 (15.4%) | |
| Age | ||||
| Mean ± SD | 61.9±9.6 | 62.1±9.2 | 61.5±10.6 | 0.722 |
| Median and Range | 62 (33–87) | 62 (33–83) | 62 (33–87) | |
| Ethnicity | ||||
| Hispanic or Latino | 13 (7.9%) | 10 (8.8%) | 3 (5.9%) | 0.756 |
| Not Hispanic or Latino | 152 (92.1%) | 104 (91.2%) | 48 (94.1%) | |
| Race | ||||
| White | 121 (72%) | 82 (70.7%) | 39 (75%) | 0.911 |
| Black | 19 (11.3%) | 14 (12.1%) | 5 (9.6%) | |
| Hispanic | 13 (7.7%) | 10 (8.6%) | 3 (5.8%) | |
| Asian | 14 (8.3%) | 9 (7.8%) | 5 (9.6%) | |
| Multiple | 1 (0.6%) | 1 (0.9%) | 0 (0.0%) | |
| Stage | ||||
| 1 | 7 (5%) | 7 (7.4%) | 0 (0.0%) | 0.082 |
| 2 | 14 (9.9%) | 7 (7.4%) | 7 (15.2%) | |
| 3 | 26 (18.4%) | 20 (21.1%) | 6 (13%) | |
| 4 | 94 (66.7%) | 61 (64.2%) | 33 (71.7%) | |
| Time since completion of radiation therapy | ||||
| Mean ± SD | 53.7±60.9 | 56.5±65.1 | 47.4±50 | 0.395 |
| Median and Range | 24.5 (3–267) | 29 (3–267) | 23 (3–186) | |
| Prior Radiation Therapy | ||||
| Yes | 8 (4.9%) | 5 (4.5%) | 3 (5.9%) | 0.706 |
| No | 155 (95.1%) | 107 (95.5%) | 48 (94.1%) | |
| Chemotherapy | ||||
| Yes | 121 (75.6%) | 83 (74.1%) | 38 (79.2%) | 0.552 |
| No | 39 (24.4%) | 29 (25.9%) | 10 (20.8%) | |
| RT: Intensity Modulated Radiation Therapy (IMRT) | ||||
| Yes | 86 (51.5%) | 56 (48.3%) | 30 (58.8%) | 0.241 |
| No | 81 (48.5%) | 60 (51.7%) | 21 (41.2%) | |
| RT: Brachytherapy | ||||
| Yes | 4 (2.4%) | 3 (2.6%) | 1 (2%) | 0.999 |
| No | 163 (97.6%) | 113 (97.4%) | 50 (98%) | |
| RT: Conventional | ||||
| Yes | 70 (41.9%) | 51 (44%) | 19 (37.3%) | 0.497 |
| No | 97 (58.1%) | 65 (56%) | 32 (62.7%) | |
| RT: Stereotactic | ||||
| Yes | 2 (1.2%) | 0 (0.0%) | 2 (3.9%) | 0.092 |
| No | 165 (98.8%) | 116 (100%) | 49 (96.1%) | |
| RT site: Oral | ||||
| Yes | 14 (8.4%) | 11 (9.5%) | 3 (5.9%) | 0.555 |
| No | 153 (91.6%) | 105 (90.5%) | 48 (94.1%) | |
| RT site: Nasopharynx | ||||
| Yes | 17 (10.2%) | 10 (8.6%) | 7 (13.7%) | 0.404 |
| No | 150 (89.8%) | 106 (91.4%) | 44 (86.3%) | |
| RT site: Oropharynx | ||||
| Yes | 78 (46.7%) | 55 (47.4%) | 23 (45.1%) | 0.867 |
| No | 89 (53.3%) | 61 (52.6%) | 28 (54.9%) | |
| RT site: Hypopharynx | ||||
| Yes | 23 (13.8%) | 14 (12.1%) | 9 (17.6%) | 0.339 |
| No | 144 (86.2%) | 102 (87.9%) | 42 (82.4%) | |
| RT site: Larynx | ||||
| Yes | 22 (13.2%) | 13 (11.2%) | 9 (17.6%) | 0.320 |
| No | 145 (86.8%) | 103 (88.8%) | 42 (82.4%) | |
| RT site: Other | ||||
| Yes | 18 (10.8%) | 14 (12.1%) | 4 (7.8%) | 0.589 |
| No | 149 (89.2%) | 102 (87.9%) | 47 (92.2%) | |
| Surgery | ||||
| Yes | 82 (49.4%) | 58 (50%) | 24 (48%) | 0.866 |
| No | 84 (50.6%) | 58 (50%) | 26 (52%) | |
| RT Modality | ||||
| Intensity Modulated Radiation Therapy (IMRT) | 84 (50.3%) | 55 (47.4%) | 29 (56.9%) | 0.423 |
| Brachytherapy | 1 (0.6%) | 1 (0.9%) | 0 (0.0%) | |
| Conventional | 68 (40.7%) | 50 (43.1%) | 18 (35.3%) | |
| Stereotactic | 1 (0.6%) | 0 (0.0%) | 1 (2%) | |
| Multiple | 13 (7.8%) | 10 (8.6%) | 3 (5.9%) | |
| RT site | ||||
| Oral | 8 (4.8%) | 7 (6%) | 1 (2%) | 0.316 |
| Nasopharynx | 16 (9.6%) | 9 (7.8%) | 7 (13.7%) | |
| Oropharynx | 70 (41.9%) | 51 (44%) | 19 (37.3%) |