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
Abstract
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.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 70 participants or records.
Read the paper
Related studies
- Tryptophan Metabolism and Gut-Brain Homeostasis
- Rationale for a Multi-Factorial Approach for the Reversal of Cognitive Decline in Alzheimer’s Disease and MCI: A Review
- Prioritized Research for the Prevention, Treatment, and Reversal of Chronic Disease: Recommendations From the Lifestyle Medicine Research Summit
- Relationship between sleep disorders and gut dysbiosis: what affects what?
- The role of CLOCK gene in psychiatric disorders: Evidence from human and animal research
- Genetic, Transcriptome, Proteomic, and Epidemiological Evidence for Blood-Brain Barrier Disruption and Polymicrobial Brain Invasion as Determinant Factors in Alzheimer’s Disease
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.