Table 1.

Baseline Characteristics, and Stratification Factors

	Treatment (n*=17)	Placebo (n*=16)	p-value
Age (years) [mean, (SEM**)]	59.3 (3.0)	57.0 (1.9)	0.54
Male Gender (n, %)	12 (70.6)	14 (87.5)	0.4
Primary site of cancer (n, %)
Lung	8 (47.0)	5 (31.2)	0.48
Head and neck	2 (11.8)	4 (25)	0.40
Other gastroenterology	2 (11.8)	6 (37.5)	0.12
Colorectal	1 (5.9)	0	1.00
Breast	1(5.9)	1(6.2)	1.00
Other	3 (17.6)	0	0.23
Stage of disease (n, %)
Stage 3	5 (29.4)	3 (18.7)	0.69
Stage 4	11 (64.7)	13 (81.2)	0.44
Other (T1S1I1)	1 (5.9)	0	1.00
ECOG Performance Status (n, %)
1	13 (76.47)	8 (50)	0.11
2	4 (23.53)	8 (50)	0.11
Route of nutrition support (n, %)
Oral	13 (76.5)	8 (50)	0.16
Nasogastric tube	3 (17.6)	4 (25)	0.69
Other tube feeding	1 (5.9)	4 (25)	0.17
Enteral nutrition (n, %)
No	11 (64.7)	9 (56.2)	0.73
Add	6 (35.3)	7 (43.7)	0.73
Palliative surgery (n, %)
No	17 (100)	13 (81.2)	0.10
Yes	0	3 (18.7)	0.10
Systemic treatment (n, %)
Yes	15 (88.2)	15 (93.7)	1.00
No	2 (11.8)	1 (6.2)	1.00
Line of chemotherapy
First line	6 (35.3)	9 (56.2)	0.30
Second line	3 (17.6)	0	0.23
Third line	0	0	NA
Other	1(5.9)	1 (7.2)	1.00
Concurrent chemo radiotherapy	6 (35.3)	5 (31.2)	1.00
No	1 (5.9)	1 (6.2)	1.00
Radiotherapy (n, %)
Concurrent chemotherapy	5 (29.4)	5 (31.2)	1.00
Palliative	2 (11.8)	2 (12.5)	1.00
Definitive	0	0	NA
No	10 (58.8)	9 (56.2)	1.00

*n, number of patients; **SEM, Standard Error of means; **ECOG, Eastern Cooperative Oncology Group