261P The long-term melatonin administration and cancer fatigue in breast cancer patients: A randomized, controlled, parallel-group, clinical trial

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. 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. 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: 261PBefore intervention1 month after intervention2 years after interventiona)GroupMean ±SDMeanMeanPlacebo5.56±1.594.80±1.022.93±1.04Intervention5.72±1.683.97±1.291.99±1.02P-value0.6710.0070.001b)Source of variationFP-valueGroup3.020.087Time204.15<0.001Group by time9.1570.001c)GroupCount (%)Count (%)Count (%)Placebo20 (55.6)29 (80.6)13 (43.3)Intervention29 (76.3)16 (42.1)6 (18.2)P-value0.0590.0010.030d)GroupCochran’s Q Test statisticsP-valuePlacebo10.9410.004Intervention27.30<0.001a) 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 Open table in a new tab . 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.