Table 1.
Baseline characteristics in the intention-to-treat population.
| Characteristics | ASC (n = 60) | Placebo (n = 60) |
|---|---|---|
| Age (years) | 61.0 (7.4) | 61.8 (6.8) |
| Female, n (%) | 19 (32%) | 13 (22%) |
| Performance score (0–1), n (%) | 60 (100%) | 60 (100%) |
| Previous smoking history, n (%) | ||
| 0 pack years | 29 (48%) | 24 (40%) |
| 1–10 pack years | 7 (12%) | 6 (10%) |
| >10 pack years | 24 (40%) | 30 (50%) |
| Cancer location, n (%) | ||
| Oropharynx | 53 (88%) | 55 (92%) |
| Cavum Oris | 2 (3%) | 0 (0) |
| Hypopharynx | 2 (3%) | 0 (0) |
| Larynx | 1 (2%) | 1 (2%) |
| Sinonasal | 0 (0%) | 0 (0) |
| Cancer of unknown primary | 0 (0%) | 1 (2%) |
| Nasopharyx | 2 (3%) | 3 (5.0) |
| p16 positive in patients with oropharyngeal cancer, n (%) | 51 (96%) | 52 (95%) |
| UICC8 stage, n (%): | ||
| I | 17 (28%) | 18 (30%) |
| II | 28 (47%) | 26 (43%) |
| III | 10 (17%) | 11 (18%) |
| IV | 4 (7%) | 3 (5%) |
| Duration since radiotherapy to intervention (years) | 5.8 (3.9) | 5.6 (4.5) |
| Mean radiation dose to the right SMG, Gy | 53.6 (14.6) | 53.0 (15.5) |
| Mean radiation dose to the left SMG, Gy | 51.8 (16.3) | 52.5 (18.2) |
| Mean radiation dose to the four large salivary glands, Gy | 39.9 (7.1) | 40.5 (8.9) |
| Mean radiation dose to the oral cavity, Gy | 39.5 (11.4) | 39.7 (10.5) |
| Bilateral radiotherapy, n (%) | 42 (70) | 47 (78) |
| Received concurrent chemotherapy, n (%)a | 52 (88) | 50 (83) |
| Saliva flow rate (mL/min) | ||
| Unstimulated whole saliva flow rate | 0.13 (0.05) | 0.13 (0.06) |
| Stimulated whole saliva flow rate | 1.14 (0.59) | 0.99 (0.60) |
| EORTC QLQ-H&N-35 (0–100) | ||
| HNDR | 81.9 (23.4) | 76.3 (23.2) |
| HNSS | 55.6 (38.2) | 57.1 (37.7) |
| HNSW | 33.9 (22.8) | 31.8 (19.9) |
| XQ (0–100) | 51.0 (20.5) | 47.9 (19.9) |
Note: Unless otherwise indicated, estimates are reported as means and SDs.
Abbreviations: Gy, gray; HNDR, domains for dry mouth; HNSS, domains for sticky saliva; HNSW, domains for swallowing; SMG, submandibular gland.
aNinety-five patients received cisplatin, 4 patients received paclitaxel, and 3 patients received carboplatin.