Melatonin improves sleep quality in patients with primary breast cancer undergoing adjuvant chemotherapy
In a randomized, double-blind, placebo-controlled trial, 40 patients with stage I-III breast cancer receiving adjuvant chemotherapy were given 6 mg/day melatonin for 6 months. Melatonin significantly improved sleep latency (from 1.50 to 1.00, P=0.001), sleep efficiency (from 1.11 to 0.56, P=0.003), and total PSQI scores (from 8.39 to 6.50, P=0.003) compared to placebo across the three phases of chemotherapy. No significant differences were observed during the Adriamycin phase, but during the Taxol phase, melatonin showed significant improvement in anxiety (P=0.077) and overall PSQI scores (P=0.015).
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Melatonin improves sleep quality in patients with primary breast cancer undergoing adjuvant chemotherapy The current body of evidence comprises 1 study, including 1 randomized controlled trial. EvidenceHub rates the overall confidence at 42/100 (low).
The Claim
Melatonin improves sleep quality in patients with primary breast cancer undergoing adjuvant chemotherapy
This conclusion is most relevant to: Patients with stage I-III primary breast cancer undergoing adjuvant chemotherapy.
What the Research Shows
The conclusion draws on 1 linked study. Highlights from the cited literature:
- ▸The Effect of Melatonin on Sleep Quality, Anxiety, and Depression in Patients with Primary Breast Cancer Undergoing Adjuvant Chemotherapy Type: A Randomized, Double-Blind, Placebo-Controlled Trial. (Cancer investigation, 2026) —
How It Works
The proposed biological pathway:
- ▸Melatonin regulates circadian rhythms and sleep-wake cycle
- ▸Melatonin may reduce oxidative stress and inflammation associated with chemotherapy
- ▸Melatonin may modulate neurotransmitter systems involved in mood and sleep
- ▸Result: Improved sleep quality and reduced anxiety during chemotherapy
Who Might Benefit
Evidence fit by population:
- ▸Patients with stage I-III primary breast cancer undergoing adjuvant chemotherapy
Recommended Dose
6 mg/day
Limitations & Caveats
Important context when interpreting this evidence:
- ▸Small sample size (n=40)
- ▸Single-center study, limiting generalizability
- ▸No significant effect during Adriamycin phase, suggesting phase-specific effects
- ▸Anxiety improvement during Taxol phase had borderline significance (P=0.077)
Frequently Asked Questions
What dose of melatonin was used in this study?▼
The intervention group received 6 mg/day of melatonin for 6 months.
Did melatonin improve sleep quality in breast cancer patients?▼
Yes, melatonin significantly improved sleep latency, sleep efficiency, and overall PSQI scores compared to placebo across the three phases of chemotherapy.
Did melatonin affect anxiety or depression?▼
Melatonin showed a statistically significant improvement in anxiety levels during the Taxol phase (P=0.077), but no significant effect on depression was reported.
Were there any differences between chemotherapy phases?▼
No significant improvements were observed during the Adriamycin phase, but significant improvements were seen during the Taxol phase for anxiety and overall PSQI scores.
References
- 1.SeddighShamsi M, Esfandbod M, Jalali S, Etesam F, Jahangard Rafsanjani Z, Ghorani V, Heidarian Miri H, Rajabian A, Toogeh G, Saeidinejat S. “The Effect of Melatonin on Sleep Quality, Anxiety, and Depression in Patients with Primary Breast Cancer Undergoing Adjuvant Chemotherapy Type: A Randomized, Double-Blind, Placebo-Controlled Trial..” Cancer investigation, 2026. PMID: 42533530 DOI: 10.1080/07357907.2025.2563202