Effect of oral melatonin on sleep quality, fatigue, and caregiver sleep perception in patients with head and neck cancer: A randomized double-blind placebo-controlled trial.

BACKGROUND: Sleep disturbances and fatigue are common in patients with head and neck cancer and adversely affect quality of life. Melatonin may improve sleep quality with minimal adverse effects. This study evaluated the effect of oral melatonin on sleep quality, fatigue, and caregiver sleep perception in patients with head and neck cancer. METHODS: In this prospective, randomised, placebo-controlled trial, 70 patients aged 18-65 years with head and neck cancer and sleep disturbances for >1 month were randomised to oral melatonin 3 mg (Group M, n = 35) or multivitamin (placebo) (Group P, n = 35) once daily for 14 days. Pittsburgh sleep quality index (PSQI), fatigue assessment scale (FAS), and satisfaction, alertness, timing, efficiency, and duration scores were assessed at baseline and day 14. RESULTS: Day-14 PSQI scores were lower in Group M than Group P (8.11 ± 1.55 versus 9.66 ± 1.83; P = 0.0003), with significant improvement only in Group M ( P < 0.001). FAS scores were also lower in Group M (12.66 ± 2.44 versus 14.69 ± 1.94; P = 0.0003). Caregiver sleep perception improved significantly with melatonin ( P < 0.0001). CONCLUSION: Oral melatonin improved sleep quality and reduced fatigue in patients with head and neck cancer and was associated with better caregiver sleep perception.