The Effect of Melatonin Supplementation on Cancer-Related Fatigue during Chemotherapy Treatment of Breast Cancer Patients: A Double-Blind, Randomized Controlled Study.

Simple Summary: Cancer-related fatigue is a common distressing complaint of breast cancer patients treated with chemotherapy. Nutritional quality plays a pivotal role in cancer-related fatigue, while increased interest towards new pharmacological agents has been observed. Melatonin, an endogenous hormone that regulates the human sleep–wake cycle, could alleviate cancer-related fatigue. In the present human trial, we investigated the effects of melatonin intake (i.e., 1 mg/day) vs. placebo on fatigue in women with active breast cancer over a period of 3 months. In both groups, nutritional advice regarding the Mediterranean diet was implemented. At the trial endpoint, the results showed that only patients receiving melatonin improved cancer-related fatigue compared to baseline. This implies that the oral supplementation of melatonin could ameliorate fatigue in breast cancer patients who undergo chemotherapy treatment. Cancer-related fatigue (CRF) is a common distressing complaint of breast cancer (BC) patients treated with chemotherapy. Nutritional quality plays a pivotal role in CRF, while increased interest towards new pharmacological agents has been observed. Melatonin, an endogenous hormone that regulates the human sleep–wake cycle, could alleviate CRF. In the present randomized, placebo-controlled 3-month trial, we investigated the effects of melatonin intake (i.e., 1 mg/day) vs. placebo in BC patients on CRF. In both arms, the Mediterranean diet (MD) was implemented. Medical history, anthropometry and blood withdrawal were performed. CRF was evaluated by the Functional Assessment of Chronic Illness Therapy—Fatigue questionnaire and MD adherence by the MedDietScore. In total, 49 BC women (median age 52 years) were recruited, namely N = 23 in the intervention arm and N = 26 in the placebo arm. At baseline, CRF was positively associated with body mass index (BMI), even when adjusted for age, waist circumference and blood indices related to disease prognosis (beta = −0.882, p = 0.003). At 3 months, both groups showed a BMI decrease (p < 0.05), but only the intervention group improved CRF compared to baseline (p = 0.003). No differences in CRF were observed between the groups. In conclusion, melatonin oral supplementation could ameliorate CRF in BC patients. [ABSTRACT FROM AUTHOR]