Table 2.
Clinical Oral Mucositis Scores
Oral Mucositis Assessment Scale (OMAS) | ||||||
---|---|---|---|---|---|---|
Intention to Treat Analysis | Per Protocol Analysis (period of study medication use only) | |||||
Celecoxib n=20 |
Placebo n=20 |
P value | Celecoxib n=20 |
Placebo n=20 |
P value | |
Mean OMAS Score (range 0–5) (SD) | .98 (.77) |
.97 (.86) |
.8402 | .86 (.72) |
.93 (.86) |
.6742 |
Mean OMAS Ulceration (range 0–3), (SD) | .52 (.53) |
.50 (.53) |
.6682 | .45 (.49) |
.47 (.52) |
.7632 |
Mean OMAS Erythema (range 0–2) (SD) | .46 (.28) |
.47 (.38) |
.8402 | .42 (.27) |
.46 (.38) |
.5802 |
Mean OMAS Score (0–5) immediately after 5000 centigray radiation (SD) | 1.42 (.67) n=19 |
1.36 (.88) |
.8311 | 1.31 (.68) n=16 |
1.41 (.87) n=19 |
.7211 |
Mean Peak OMAS Score (range 0–5) (SD) | 1.71 (.59) |
1.70 (.95) |
.9821 | 1.65 (.58) |
1.69 (.95) |
.8771 |
World Health Organization (WHO) Oral Mucositis Scale | ||||||
---|---|---|---|---|---|---|
Intention to Treat Analysis | Per Protocol Analysis (period of study medication use only) | |||||
Celecoxib n=20 |
Placebo n=20 |
P value | Celecoxib n=20 |
Placebo n=20 |
P value | |
Mean WHO Score (range 0–4) (SD) | 1.94 (1.40) |
1.85 (1.43) |
.6542 | 1.74 (1.35) |
1.80 (1.43) |
.8882 |
WHO Score immediately after 5000 cGy radiation (SD) | 2.47 (1.17) n=19 |
2.55 (1.00) |
.8281 | 2.31 (1.20) n=16 |
2.58 (1.02) n=19 |
.4812 |
Peak WHO Score (SD) | 3.40 (.68) |
2.95 (1.15) |
.1391 | 3.05 (.76) |
2.95 (1.15) |
.7471 |
Number of Days with WHO Grade 3 or 4 Mucositis (SD) | 15.85 (13.48) |
17.05 (15.16) |
.7931 | 10.05 (10.79) |
13.85 (12.76) |
.3161 |
National Cancer Institute Common Toxicity Criteria (NCI-CTC) Oral Mucositis Scale | ||||||
---|---|---|---|---|---|---|
Intention to Treat Analysis | Per Protocol Analysis (period of study medication use only) | |||||
Celecoxib n=20 | Placebo n=20 | P value | Celecoxib n=20 | Placebo n=20 | P value | |
Mean NCI-CTC Score (Range 0–4) (SD) | 2.00 (1.07) |
1.85 (1.12) |
.3242 | 1.86 (1.07) |
1.81 (1.13) |
.6542 |
NCI-CTC immediately after 5000 cGy Radiation (SD) | 2.63 (.60) n=19 |
2.50 (.83) |
.5741 | 2.56 (.63) n=16 |
2.53 (.84) n=19 |
.8881 |
Peak NCI-CTC (SD) | 2.85 (.37) |
2.55 (.37) |
.0931 | 2.84 (.38) |
2.55 (.69) |
.1101 |
Number of Days with NCI- | 19.60 | 18.20 | .7671 | 14.35 | 16.15 | .6671 |
CTC Grade 3 or higher (SD) | (14.12) | (15.50) | (12.27) | (13.96) |
Two-sample t-test,
linear mixed models