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Melatonin (MEL), an indoleamine with pleiotropic biological activities, has emerged as a promising adjuvant in oncology due to its antiproliferative, proapoptotic, and antioxidant properties. This review synthesizes current evidence on MEL's molecular mechanisms in GI carcinogenesis, including modulation of NF\u2010\u03baB, PI3K\/AKT, and Wnt\/\u03b2\u2010catenin pathways, suppression of reactive oxygen species (ROS), and regulation of circadian rhythm\u2010related genes (e.g., CLOCK, BMAL1). Preclinical studies demonstrate that MEL enhances chemoradiotherapy efficacy\u2010reducing tumor volume by 70% in murine colorectal models and decreasing 5\u2010fluorouracil (5\u2010FU) resistance via miR\u2010532\u20103p\/\u03b2\u2010catenin axis modulation. Clinical trials report a 23%\u201341% risk reduction in colorectal cancer among shift workers with MEL supplementation and a 53% decrease in radiotherapy\u2010induced oral mucositis. Despite promising data, limitations persist: fewer than 15% of clinical trials focus on GI cancers, dosing remains unstandardized (10\u201340\u2009mg\/day), and molecular heterogeneity (e.g., KRAS mutations in pancreatic cancer) may limit therapeutic responses. Future research must prioritize phase III trials, chronotherapy optimization, and biomarker\u2010driven approaches, including MT1\/MT2 receptor expression and microbiome profiling. Given its low toxicity and putative synergy with immunotherapies, MEL should be regarded as an adjunct under investigation rather than an established option; to date, no GI\u2010specific phase III randomized trials exist, and clinical signals come primarily from small, heterogeneous cohorts. Dosing is unstandardized and limited by low oral bioavailability (first\u2010pass) and possible pharmacogenomic variability.<\/jats:p>","DOI":"10.1111\/jpi.70101","type":"journal-article","created":{"date-parts":[[2025,12,4]],"date-time":"2025-12-04T12:47:50Z","timestamp":1764852470000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Therapeutic Potential of Melatonin in Gastrointestinal Cancers: Molecular Mechanisms, Preclinical Evidence and Clinical Implications"],"prefix":"10.1111","volume":"78","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1322-2457","authenticated-orcid":false,"given":"Maciej","family":"Gonciarz","sequence":"first","affiliation":[{"name":"Department of Gastroenterology and Internal Medicine Military Institute of Medicine \u2013 National Research Institute Warsaw Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1404-2274","authenticated-orcid":false,"given":"Benita","family":"Wiatrak","sequence":"additional","affiliation":[{"name":"Department of Pharmacology Wroclaw Medical University Wroclaw Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iga","family":"Lombard","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Internal Medicine Military Institute of Medicine \u2013 National Research Institute Warsaw Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"\u0141ukasz","family":"Konecki","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Internal Medicine Military Institute of Medicine \u2013 National Research Institute Warsaw Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2783-2280","authenticated-orcid":false,"given":"Joanna","family":"Sarbinowska","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Internal Medicine Military Institute of Medicine \u2013 National Research Institute Warsaw Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,12,4]]},"reference":[{"key":"e_1_2_10_2_1","unstructured":"National Center for Biotechnology Information. 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