Randomized phase II trial of selenomethionine as a modulator of efficacy and toxicity of chemoradiation in squamous cell carcinoma of the head and neck

Table 1 Baseline characteristics

Characteristic		Placebo(n = 8)	Selenium(n = 10)	P value
Median age		55.5	59.5	0.700
Male sex		7	10	0.165
Race	White	4	8	0.180
	Other	4	2
Best response	CR	7	6	0.196
	Not evaluable	1	4
T stage	1	3	0	0.063
	2	2	5
	3	0	3
	4	3	1
	X	0	1
N stage	1	0	1	0.103
	2	6	8
	3	1	1
	X	1	0
M stage	0	5	10	0.105
	X	3	0
Stage group	IVA	7	8	0.108
	IVB	1	1
	Unkn	0	1

Unkn: Unknown; CR: Complete response.

Table 2 Mucositis scores

Mucositis grade	Placebo(n = 8)	SLM(n = 10)
0	1	2
1	1	3
2	3	3
3	3	2

SLM: Selenomethionine.

Table 3 Other adverse events

Toxicity ≥ grade 2	Placebo	SLM
Dermatitis	0	2
Dry mouth	2	0
Dysgeusia	1	2
Anemia	1	0
Leukopenia	2	3
Thrombocytopenia	0	0
Odyno-/dysphagia	2	1
Oral/throat pain	2	0
Phlegm	1	3
Elevated creatinine	1	0
Hearing dysfunction	1	1

SLM: Selenomethionine.