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Background <p>Cancer-related fatigue (CRF) is a prevalent and debilitating symptom among patients undergoing cancer treatment, yet its management remains a clinical challenge. Previous studies evaluating the role of melatonin in CRF have yielded inconsistent findings. This meta-analysis aimed to assess the overall effect of melatonin supplementation on fatigue and to explore potential dose–response relationships.</p> Methods <p>A systematic literature search was performed in PubMed, Scopus, Web of Science, and Google Scholar up to 24 August 2025. Randomized controlled trials comparing melatonin with a placebo in adult cancer patients were included. SMDs with 95% CIs were calculated using a random-effects model. Nonlinear and linear dose–response analyses were conducted, and certainty of evidence was evaluated with the GRADE approach.</p> Results <p>Twelve trials (18 effect sizes, <i>n</i> = 1,977) met the inclusion criteria. Pooled analysis showed a significant reduction in fatigue scores with melatonin supplementation (SMD: −0.45; 95% CI: −0.69, − 0.20; <i>P</i> &lt; 0.001). Dose–response analysis revealed a significant inverse association for melatonin doses between 5 and 15&#xa0;mg/day (P-nonlinearity = 0.03). Short-term interventions (≤ 4 weeks) demonstrated greater benefit, whereas longer durations showed no consistent effects. However, substantial heterogeneity (I² = 78%) and very low certainty of evidence limit the robustness of these findings.</p> Conclusions <p>Melatonin supplementation may reduce fatigue in cancer patients, particularly at doses of 5–15&#xa0;mg/day and with short-term use. Nonetheless, the certainty of evidence remains very low, highlighting the need for high-quality, large-scale RCTs with standardized methodologies to validate these results.</p>

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Exploring the impact of melatonin on cancer-related fatigue: a dose-response meta-analysis with GRADE evidence evaluation

  • 期刊论文

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  • 发表日期：

    2026年5月26日

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  • Sajjad Etesamnia,
  • Mahdiyar Nasiraie-Moghadam,
  • Pariya Mostafazadeh,
  • Mohammad-Reza Jowshan,
  • Kamran Roudini,
  • Seyed Rohollah Miri,
  • Alireza Jahan-Mihan,
  • Alireza Haghighi,
  • Soraiya Ebrahimpour-Koujan

摘要

Background

Cancer-related fatigue (CRF) is a prevalent and debilitating symptom among patients undergoing cancer treatment, yet its management remains a clinical challenge. Previous studies evaluating the role of melatonin in CRF have yielded inconsistent findings. This meta-analysis aimed to assess the overall effect of melatonin supplementation on fatigue and to explore potential dose–response relationships.

Methods

A systematic literature search was performed in PubMed, Scopus, Web of Science, and Google Scholar up to 24 August 2025. Randomized controlled trials comparing melatonin with a placebo in adult cancer patients were included. SMDs with 95% CIs were calculated using a random-effects model. Nonlinear and linear dose–response analyses were conducted, and certainty of evidence was evaluated with the GRADE approach.

Results

Twelve trials (18 effect sizes, n = 1,977) met the inclusion criteria. Pooled analysis showed a significant reduction in fatigue scores with melatonin supplementation (SMD: −0.45; 95% CI: −0.69, − 0.20; P < 0.001). Dose–response analysis revealed a significant inverse association for melatonin doses between 5 and 15 mg/day (P-nonlinearity = 0.03). Short-term interventions (≤ 4 weeks) demonstrated greater benefit, whereas longer durations showed no consistent effects. However, substantial heterogeneity (I² = 78%) and very low certainty of evidence limit the robustness of these findings.

Conclusions

Melatonin supplementation may reduce fatigue in cancer patients, particularly at doses of 5–15 mg/day and with short-term use. Nonetheless, the certainty of evidence remains very low, highlighting the need for high-quality, large-scale RCTs with standardized methodologies to validate these results.