Effect of Melatonin on Cognitive Function and Sleep in relation to Breast Cancer Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial
Table 1
Baseline, perioperative, and demographic characteristics.
Patient characteristics
MELATONIN ()
PLACEBO ()
Age (years)
51 (46–66)
60 (49–68)
BMI (kg/m2)
24.3 (21.2–27.1)
24.2 (21.3–26.3)
Menopausal status (pre/post)
14/14
10/16
ASA physical status class I/II/III
19/8/1
17/7/0
Level of education
Finished grade 8
1
1
Finished grade 9/10
5
5
Graduate from high school
3
3
Some college
7
10
Bachelor’s degree
8
6
Master’s degree
4
1
Job status
Student
0
0
Employed
19
14
Unemployed
1
0
Sick-leave
1
0
Disability pension
0
1
Retired
7
11
Relationship status
Married or living as married
21
22
Divorced
3
4
Widowed
1
0
Single
3
0
Household income
Not given
0
1
<300.000 kr.
6
5
300.000–600.000 kr.
11
10
600.000–900.000 kr.
5
8
>900.000 kr
6
3
Smoker (YES/NO/EX-SMOKER)
5/16/7
5/14/7
Type of surgery
Mastectomy + axillary dissection +/− SN
1
3
Mastectomy + SN
4
3
Lumpectomy + axillary dissection +/− SN
6
6
Lumpectomy + SN
16
12
Lumpectomy → mastectomy + SN
1
0
Bilateral lumpectomy + SN + axillary dissection
0
2
Surgery duration (min)
92 (74.5–125)
125 (104.5–156.5)
Anaesthesia duration (min)
155 (130–187)
190 (155–225)
Oncological treatment‡
None
3
3
Radiation
5
6
Chemotherapy
16
7
Chemotherapy + radiation
0
0
Radiation × 1 only
3
1
Antihormone‡ (no/yes (femar/letrozol/tamoxifen))
20/7
10/7
MDI baseline
6.5 (4–12.5)
7 (4.5–10)
Values are frequencies or median (25–75% IQR). ASA: American society of anesthesiologists BMI: body mass index SN: sentinel node. ‡Only registered as which oncological treatment and antihormone therapy (if any at all) the patients received during their participation in the MELODY trial.
