Table 1.
Baseline demographic and clinical characteristics according to treatment group. Data are presented as mean standard deviation (SD) (n = 36).
| Variables | Melatonin (n = 18) | Placebo (n = 18) | P-value |
|---|---|---|---|
| Age (years) | 54.24 (10.59) | 54.11 (9.15) | 0.97 |
| Formal education (years) | 9.29 (4.04) | 6.94 (2.57) | 0.08† |
| Body mass index (kg/m2) | 28.0 (6.14) | 29.94 (5.70) | 0.25† |
| Visual analog scale (0–100) | 50 (20.00) | 50 (16.48) | 0.80 |
| Brain-derived neurotrophic factor (ng/mL) | 42.92 (17.54) | 42.24 (23.95) | 0.92 |
| Tropomyosin receptor kinase B (ng/mL) | 0.48 (0.25) | 0.47 (0.50) | 0.49 |
| Protein S100B (pg/mL) | 38.16 (12.42) | 32.37 (8.93) | 0.21 |
| Pittsburgh Sleep Quality Index | 8.24 (3.97) | 8.44 (2.83) | 0.86 |
| Beck Depression Inventory II | 11.41 (7.73) | 10.83 (5.11) | 0.79 |
| Chronic disease | |||
| Hypertension | 7 (38.9%)/11 (61.1%) | 8 (44.4%)/10 (55.6%) | |
| Hypothyroidism | 3 (16.7%)/15 (83.3%) | 1 (5.6%)/17 (94.4%) | |
| Diabetes mellitus | 1 (5.6%)/17 (94.4%) | 1 (5.6%)/17 (94.4%) | |
| Asthma | 1 (5.6%)/17 (94.4%) | 1 (5.6%)/17 (94.4%) | |
| Psychotropic medication (yes/no)* | |||
| Number of psychotropic medications | 8/18 (44.44%) | 9/18 (50%) | |
| Selective serotonin reuptake inhibitors | 3 (16.7%)/15 (83.3%) | 3 (16.7%)/15 (83.3%) | |
| Tricyclics | 1 (5.6%)/17 (94.4%) | 2 (11.1%)/16 (88.9%) | |
| Benzodiazepines | 3 (16.7%)/15 (83.3%) | 4 (22.2%)/14 (77.8%) | |
| Antipsychotics | 1 (5.6%)/17 (94.4%) | :::: | |
| Chemotherapy regimens (yes/no) | |||
| ACT (doxorubicin plus cyclophosphamide followed by weekly paclitaxel)1 | 9 (50%)/9 (50%) | 9 (50%)/9 (50%) | |
| AC (doxorubicin plus cyclophosphamide)1 | 5 (27.8%)/13 (72.2%) | 2 (11.1%)/16 (88.9%) | |
| ACTH (doxorubicin plus cyclophosphamide followed by paclitaxel plus trastuzumab)1 | 2 (11.1%)/16 (88.9%) | 3 (16.7%)/(83.3%) | |
| TAC (docetaxel, doxorubicin, and cyclophosphamide)2 | 1 (5.6%)/17 (94.4%) | 2 (11.1%)/16 (88.9%) | |
| TC (docetaxel plus cyclophosphamide)2 | 1 (5.6%)/17 (94.4%) | 2 (11.1%)/16 (88.9%) | |
†Mann-Whitney non-parametric test was used. Independent t-tests were applied to all other measures.
*Three patients use more than one psychotropic medication.
Prophylaxis for infusion reactions:
1Dexamethasone 20 mg IV 30 min before drug administration.
2Dexamethasone 8 mg orally every 12 h starting one day prior to docetaxel administration.