Skip to main content

Table 1 Demographic, baseline oncologic and comorbidity characteristics in randomized study groups

From: Melatonin to prevent delirium in patients with advanced cancer: a double blind, parallel, randomized, controlled, feasibility trial

Characteristic

Study Group

All patients

P value

Placebo n = 30 (%)

Melatonin n = 30 (%)

Total

n = 60 (%)

Age, yrsa

67 (60–76)

67 (59–75)

67 (60–75)

0.531

Sex: female

13 (43.3)

14 (46.7)

27 (45.0)

0.795

Primary cancer

 Lung

12 (40.0)

8 (26.7)

20 (33.3)

0.531

 Gastrointestinal

7 (23.3)

9 (30.0)

16 (26.7)

 Genitourinary

4 (13.3)

4 (13.3)

8 (13.3)

 Breast

4 (13.3)

2 (6.7)

6 (10.0)

 Hematologic

1 (3.3)

1 (3.3)

2 (3.3)

 Head & Neck

1 (3.3)

0 (0.0)

1 (1.67)

 Primary Brain

0 (0.0)

2 (6.7)

2 (3.3)

 Other

1 (3.3)

4 (13.3)

5 (8.3)

Metastatic sites of cancer

 Lung

8 (26.7)

12 (40.0)

20 (33.3)

0.273

 Liver

12 (40.0)

14 (46.7)

26 (43.3)

0.602

 Brain

12 (40.0)

8 (26.7)

20 (33.3)

0.273

 Leptomeningeal

5 (16.7)

1 (3.3)

6 (10.0)

0.195

 Bone

17 (56.7)

14 (46.7)

31 (51.7)

0.438

Palliative Performance Scale (PPS)a

40 (30–50)

40 (30–50)

40 (30–50)

0.613

Charlson Comorbidity Index (CCI)a

10 (9–11)

10 (9–13)

10 (9–12)

0.270

Baseline Goals of Care

 Comfort only

6 (20.0)

7 (23.3)

13 (21.7)

0.750

 Medical

19 (63.3)

18 (60.0)

37 (61.7)

 Medical & Transfer

5 (16.7)

4 (13.3)

9 (15.0)

 Full Resuscitation

0 (0.0)

1 (3.3)

1 (1.67)

ECS-CPb Pain mechanism

 No pain syndrome

4 (13.3)

8 (26.7)

12 (20.0)

0.076

 Nociceptive

18 (60.0)

9 (30.0)

27 (45.0)

 Neuropathic

8 (26.7)

12 (40.0)

20 (33.3)

 Unknown or missing

0 (0)

1 (3.3)

1 (1.67)

ECS-CPb Incident pain

 Present

15 (50.0)

13 (43.3)

28 (46.7)

0.606

 Absent

14 (46.7)

17 (56.7)

31 (51.7)

 Unknown or missing

1 (3.3)

0 (0)

1 (1.67)

ESAS-r symptom intensity,c

 Paina

3 (2–3)

2 (0–5)

2.5 (1–4)

0.786

 Tirednessa

5 (3–6)

4.5 (2–6.5)

5 (3–6)

0.525

 Drowsinessa

3 (1–6)

4.5 (2–6.5)

4 (1–6)

0.413

 Nauseaa

0 (0–2)

0 (0–0.5)

0 (0–1)

0.486

 Lack of appetitea

3.5 (0–7)

3.5 (0–7)

3.5 (0–7)

0.923

 Short of breatha

2 (0–4)

0 (0–2)

1 (0–3)

0.072

 Depressiona

1 (0–3)

0 (0–3)

0.5 (0–3)

0.584

 Anxietya

1 (0–4)

2 (0–5)

2 (0–4)

0.787

 Well beinga

4.5 (2–6)

3.5 (2–5.5)

4 (2–6)

0.644

 Sleepa

4 (0–6)

3.5 (0–6)

4 (0–6)

0.847

  1. aContinuous variables expressed as median (Q1-Q3)
  2. bECS-CP: Edmonton Classification System for Cancer Pain
  3. cESAS-r: Edmonton Symptom Assessment System Revised; number of missing ratings (placebo, melatonin) for each symptom: pain (4, 2); tired (4, 2); drowsiness (5, 2); nausea (4, 2); lack of appetite (4, 2); short of breath (4, 2); depression (4, 2) anxiety (5, 2); well being (4, 2); sleep (7, 2)
Back to article page

BMC Palliative Care

ISSN: 1472-684X

Contact us