Abstract 261P
Background
Cancer related fatigue is a distressing condition and correlated with decrease in quality of life of patients with malignant conditions. In continuation of our previous research, we assessed long term anti-fatigue effects of melatonin in patients with the breast cancer.
Methods
The study was a randomized, controlled, parallel-group, trial. Patients with non metastatic breast cancer were randomly assigned to receive melatonin (The intervention group) or placebo. Ninty-two patients were randomly enrolled in each group. The intervention group received oral melatonin (18 mg/day) from 1 week before until 2 years after the adjuvant treatments (adjuvant chemotherapy and radiotherapy). The levels of fatigue were assessed before and after intervention using Brief Fatigue Inventory (BFI) in both groups. To analyze data, the Student's t-test and the Chi-square test were used at a significance level of P ≤ .05.
Results
The BFI score was similar prior to the intervention in both groups. After the intervention, not only both the mean fatigue score and severity of fatigue were significantly lower in melatonin group (P≤ .05) (Table), a greater decrease in fatigue score in intervention group is evident overtime. (P≤0.001). Table: 261P
| Before intervention | 1 month after intervention | 2 years after intervention | |
| a) | |||
| Group | Mean ±SD | Mean | Mean |
| Placebo | 5.56±1.59 | 4.80±1.02 | 2.93±1.04 |
| Intervention | 5.72±1.68 | 3.97±1.29 | 1.99±1.02 |
| P-value | 0.671 | 0.007 | 0.001 |
| b) | |||
| Source of variation | F | P-value | |
| Group | 3.02 | 0.087 | |
| Time | 204.15 | <0.001 | |
| Group by time | 9.157 | 0.001 | |
| c) | |||
| Group | Count (%) | Count (%) | Count (%) |
| Placebo | 20 (55.6) | 29 (80.6) | 13 (43.3) |
| Intervention | 29 (76.3) | 16 (42.1) | 6 (18.2) |
| P-value | 0.059 | 0.001 | 0.030 |
| d) | |||
| Group | Cochran’s Q Test statistics | P-value | |
| Placebo | 10.941 | 0.004 | |
| Intervention | 27.30 | <0.001 | |
| a) Mean BFI score over time by groups; b) Results of repeated measurement analysis of variance; c) The number of patients with severe fatigue over time by groups; d) Results of generalized estimating equation |
Conclusions
Our findings support using melatonin as a safe and effective therapeutic medicine for decreasing the levels of fatigue and improving the quality of life of patients with breast cancer. Considering the improved survival of patients with breast cancer and given the long-term adverse effects of suffering from breast cancer and its treatments on various aspects of patients life, a more extended psychological and medical supports might be essential.
Both Drs. Keshpour Amlashi and Seyed Alireza Javadinia have equally contributed to the study.
Clinical trial identification
IRCT20180426039421N3.
Legal entity responsible for the study
The authors.
Funding
Hamadan University of Medical Sciences, Hamadan, Iran.
Disclosure
All authors have declared no conflicts of interest.