{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T21:44:31Z","timestamp":1790286271778,"version":"4.1.0"},"reference-count":22,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2023,4,26]],"date-time":"2023-04-26T00:00:00Z","timestamp":1682467200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Pineal Research"],"published-print":{"date-parts":[[2023,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aim<\/jats:title><jats:p>This was a double\u2010blind, placebo\u2010controlled randomized study investigating whether melatonin can protect against radiation dermatitis in women receiving radiation therapy for primary breast cancer.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients were included before radiation therapy and followed once weekly throughout treatment with a 3\u2010week follow\u2010up. Patients applied 1\u2009g of cream to the irradiated skin twice daily, consisting of either 25\u2009mg\/g melatonin and 150\u2009mg\/g dimethyl sulfoxide, or placebo. Our outcomes were the Radiation Therapy Oncology Group's (RTOG) acute radiation morbidity scoring criteria for skin, a pixel analysis of erythema in clinical photographs, and patients\u2019 use of corticosteroid cream. Outcomes were evaluated once weekly throughout the trial. The primary outcomes were RTOG\u2010score and pixel analysis at 2 weeks follow\u2010up. Secondary outcomes were the use of corticosteroid cream and analyses of RTOG\u2010scores and pixel analyses throughout the trial.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Sixty\u2010five patients were included, 17 dropped out, totaling 26 and 22 patients randomized to melatonin and placebo, respectively. RTOG\u2010scores and pixel analyses at 2 weeks follow\u2010up showed no difference <jats:italic>p<\/jats:italic>\u2009=\u2009.441 and <jats:italic>p<\/jats:italic>\u2009=\u2009.890, respectively). There was no difference in the use of corticosteroid cream (<jats:italic>p<\/jats:italic>\u2009=\u2009.055). Using logistic regression, the melatonin group had a higher likelihood of having a low RTOG\u2010score (<jats:italic>p<\/jats:italic>\u2009=\u2009.0016). The logistic regression showed no difference between the groups for the pixel analyses.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Our primary outcome showed no difference in RTOG\u2010scores at 2 weeks follow\u2010up, however, the RTOG\u2010score over the entire duration of the study demonstrated a protective effect of melatonin. Further studies are warranted investigating higher doses of melatonin, and whether corticosteroids may influence the effect of melatonin cream against radiation dermatitis.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jpi.12873","type":"journal-article","created":{"date-parts":[[2023,4,14]],"date-time":"2023-04-14T04:49:05Z","timestamp":1681447745000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Effect of melatonin cream on acute radiation dermatitis in patients with primary breast cancer: A double\u2010blind, randomized, placebo\u2010controlled trial"],"prefix":"10.1111","volume":"75","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8533-8777","authenticated-orcid":false,"given":"Dennis","family":"Zetner","sequence":"first","affiliation":[{"name":"Department of Surgery, Herlev Hospital University of Copenhagen Herlev Denmark"},{"name":"Department of Radiology, Rigshospitalet University of Copenhagen Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claus","family":"Kamby","sequence":"additional","affiliation":[{"name":"Department of Oncology, Rigshospitalet University of Copenhagen Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Camilla","family":"Christophersen","sequence":"additional","affiliation":[{"name":"Department of Surgery, Herlev Hospital University of Copenhagen Herlev Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seng\u00fcl","family":"G\u00fclen","sequence":"additional","affiliation":[{"name":"Department of Surgery, Herlev Hospital University of Copenhagen Herlev Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cecilie B.","family":"Paulsen","sequence":"additional","affiliation":[{"name":"Department of Surgery, Herlev Hospital University of Copenhagen Herlev Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emily","family":"Piga","sequence":"additional","affiliation":[{"name":"Department of Surgery, Herlev Hospital University of Copenhagen Herlev Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bodil","family":"Hoffmeyer","sequence":"additional","affiliation":[{"name":"Department of Surgery, Herlev Hospital University of Copenhagen Herlev Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Faisal","family":"Mahmood","sequence":"additional","affiliation":[{"name":"Department of Oncology, Odense University Hospital University of Southern Denmark Odense Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacob","family":"Rosenberg","sequence":"additional","affiliation":[{"name":"Department of Surgery, Herlev Hospital University of Copenhagen Herlev Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,4,26]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2005.08.054"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ctarc.2021.100403"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13555-016-0120-y"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvs.2010.06.175"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0035-1569358"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1159\/000510252"},{"key":"e_1_2_8_8_1","first-page":"188","article-title":"Melatonin for prevention of breast radiation dermatitis: a phase II, prospective, double\u2010blind randomized trial","volume":"18","author":"Ben\u2010David MA","year":"2016","journal-title":"Israel Med Assoc J"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/0360-3016(95)00060-C"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/jocn.13430"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/odi.13265"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1089\/acm.2017.0081"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12094-021-02586-w"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.32794\/mr11250010"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.c332"},{"key":"e_1_2_8_16_1","unstructured":"Danish Breast Cancer Group. 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