Table 1 Summary of patients enrolled in the trial and comparison of baseline characteristics between standard care and intervention groups

From: Randomised controlled trial of early prophylactic feeding vs standard care in patients with head and neck cancer

Variable

Total ( n =131)

Standard care ( n =70)

Intervention ( n =61)

P -value

Age

Years (mean±s.d.)

60.5±10.1

60.0±10.9

61.1±9.1

0.558

Sex

Male

115 (88)

59 (84)

56 (92)

0.19

Female

16 (12)

11 (16)

5 (8)

 

Smoking history

Non smoker

26 (20)

14 (20)

12 (20)

0.147

Former

81 (62)

39 (56)

42 (69)

 

Current

24 (18)

17 (24)

7 (11)

 

Tumour site

Oral cavity

14 (11)

7 (10)

7 (11)

0.885

Oropharynx

101 (77)

56 (80)

45 (74)

 

Nasopharynx

4 (3)

2 (3)

2 (3)

 

Hypopharynx

8 (6)

3 (4)

5 (8)

 

Larynx

2 (1)

1 (1)

1 (2)

 

UKP

1 (1)

0 (0)

1 (2)

 

Other

1 (1)

1 (1)

0 (0)

 

T stage

T0

1 (1)

0 (0)

1 (2)

0.111

T1

8 (6)

4 (5)

4 (7)

 

T2

44 (34)

20 (29)

24 (39)

 

T3

37 (28)

26 (37)

11 (18)

 

T4

41 (31)

20 (29)

21 (34)

 

N stage

N0

12 (9)

7 (10)

5 (8)

0.629

N1

13 (10)

8 (11)

5 (8)

 

N2a

4 (3)

1 (1)

3 (5)

 

N2b

55 (42)

30 (43)

25 (41)

 

N2c

42 (32)

20 (29)

22 (36)

 

N3

5 (4)

4 (6)

1 (2)

 

P16 status

Positive

85 (69)

43 (65)

42 (72)

0.385

Negative

39 (31)

23 (35)

16 (28)

 

Treatment

ChemoRT

123 (94)

67 (96)

56 (92)

0.472

Other

8 (6)

3 (4)

5 (8)

 

Chemotherapy

HD cisplatin

68 (58)

36 (56)

32 (60)

0.382

Weekly cisplatin

25 (21)

12 (19)

13 (25)

 

Cetuximab

24 (21)

16 (25)

8 (15)

 

Weight loss 6 months

Nil

51 (39)

22 (31)

29 (48)

0.266

<5%

43 (33)

27 (39)

16 (26)

 

5–10%

22 (17)

12 (17)

10 (16)

 

10%

15 (11)

9 (13)

6 (10)

 

Nutritional status

PGSGA A

99 (76)

50 (71)

49 (80)

0.237

PGSGA B

32 (24)

20 (29)

12 (20)

 

PGSGA C

0 (0)

0 (0)

0 (0)

 

Diet

Full

87 (66)

47 (67)

40 (66)

0.579

Soft

35 (27)

20 (29)

15 (25)

 

Minced

8 (6)

3 (4)

5 (8)

 

Puree

1 (1)

0 (0)

1 (1)

 

Anthropometry

Weight (kg)

82.6±18.7

79.7±18.7

85.8±18.4

0.063

Fat-free mass (kg)

59.2±10.4

57.6±10.5

60.9±10.1

0.073

BMI (kg m−2)

27.2±5.5

26.4±5.7

28.1±5.2

0.078

Nutrition risk

PGSGA score (median, range)

6 (1–21)

6 (1–21)

5 (1–20)

0.052

  1. Abbreviations: BMI=body mass index; ChemoRT=chemoradiotherapy; HD=high dose; PGSGA=Patient-Generated Subjective Global Assessment; UKP=unknown primary.