Table 1.
Baseline characteristics in the mITT population.
| ASCs (n = 15) | Placebo (n = 15) | Total (n = 30) | |
|---|---|---|---|
| Characteristica | |||
| Age (years) | 58.3 (±7.1) | 60.3 (±7.9) | 59.3 (±7.4) |
| Males, n (%) | 9 (60) | 10 (67) | 19 (63) |
| Ethnicity, Caucasian, n (%) | 15 (100) | 15 (100) | 30 (100) |
| Smoking status, n (%) | |||
| Current | 0 (0) | 1 (7) | 1 (3) |
| Prior | 6 (40) | 4 (27) | 10 (33) |
| Never | 9 (60) | 10 (67) | 19 (63) |
| Primary tumor site, n (%) | |||
| Tonsil | 13 (87) | 13 (87) | 26 (87) |
| Base of tongue | 2 (13) | 2 (13) | 4 (13) |
| T stage, n (%) | |||
| T1 | 7 (47) | 5 (33) | 12 (40) |
| T2 | 6 (40) | 10 (67) | 16 (53) |
| T3 | 2 (13) | 0 (0) | 2 (7) |
| N stage, n (%) | |||
| N0 | 2 (13) | 1 (7) | 3 (10) |
| N1 | 4 (27) | 2 (13) | 6 (20) |
| N2a | 2 (13) | 2 (13) | 4 (13) |
| N2b | 7 (47) | 9 (60) | 16 (53) |
| N2c | 0 (0) | 1 (7) | 1 (3) |
| Treatment, n (%) | |||
| Radiotherapy only | 2 (13) | 1 (7) | 3 (10) |
| Radiotherapy with cisplatin | 13 (87) | 14 (93) | 27 (90) |
| Duration from radiotherapy to intervention, years | 4.0 (±1.2) | 3.5 (±1.2) | 3.7 (±1.2) |
| Radiation of SMG (Gy): | |||
| Mean RT dose ipsilateral SMG | 65.7 (±3.9) | 65.4 (±2.8) | 65.5 (±3.2) |
| Mean RT dose contralateral SMG | 41.0 (±19.3) | 37.8 (±13.9) | 39.4 (±16.8) |
| Mean RT dose SMG, base of tongue | 59.9 (±6.6) | 63.5 (±3.9) | 61.7 (±5.7) |
| Whole saliva production (mL/minute)b | |||
| Unstimulated whole saliva flow rate | 0.12 (0.06–0.15) | 0.13 (0.09–0.21) | 0.12 (0.09–0.21) |
| Stimulated whole saliva flow rate | 0.74 (0.63–1.33) | 0.90 (0.79–1.18) | 0.85 (0.72–1.18) |
| Patient-reported complaints of xerostomiab | |||
| XQ, summary score (scale: 0–100) | 51 (39–65) | 49 (31–71) | 51 (33–71) |
| VAS, VAS score (scale: 0–100) | |||
| Difficulty speaking (#1) | 20 (7–41) | 22 (8–28) | 21 (8–28) |
| Difficulty swallowing (#2) | 45 (29–74) | 36 (23–60) | 44 (25–70) |
| Amount of saliva (#3) | 45 (20–77) | 48 (26–71) | 47 (26–75) |
| Dry mouth (#4) | 44 (19–86) | 47 (35–66) | 46 (26–77) |
| Dry throat (#5) | 46 (20–87) | 48 (40–67) | 48 (35–73) |
| Dry lips (#6) | 42 (23–74) | 47 (4–74) | 46 (9–74) |
| Dry tongue (#7) | 36 (17–47) | 39 (12–58) | 38 (17–51) |
| Level of thirst (#8) | 52 (22–92) | 41 (6–67) | 43 (16–67) |
| MRI-evaluated volume of SMG (cm3)b | |||
| MRI volume of left SMG | 5.3 (3.8–6.0) | 5.7 (4.6–7.9) | 5.5 (4.2–6.9) |
| MRI volume of right SMG | 5.5 (3.8–6.3) | 6.2 (4.0–6.5) | 5.8 (4.0–6.5) |
Abbreviations: Gy, gray; mITT, modified intention-to-treat; MRI, magnetic resonance imaging; RT, radiation therapy; SMG, submandibular gland; VAS, visual analog scale; XQ, Xerostomia Questionnaire.
aValues are reported as means (SD) unless otherwise stated.
bValues are reported as medians with IQRs.