{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T15:39:59Z","timestamp":1790177999437,"version":"4.1.0"},"reference-count":20,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2024,1,25]],"date-time":"2024-01-25T00:00:00Z","timestamp":1706140800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,1,25]],"date-time":"2024-01-25T00:00:00Z","timestamp":1706140800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100015757","name":"Fundaci\u00f3n P\u00fablica Andaluza Progreso y Salud","doi-asserted-by":"publisher","award":["AP-0235-2019"],"award-info":[{"award-number":["AP-0235-2019"]}],"id":[{"id":"10.13039\/501100015757","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Dermatitis is a skin condition caused by multiple causes, including radiotherapy treatment. Pharmacological treatments can become chronic and are not exempt from side effects. The latest recommendations of the American Academy of Dermatology establish the use of natural, nourishing, and moisturizing cosmetic products as prevention and the first therapeutic step for dermatitis. Alantel\u00ae is a cream developed to reduce redness and irritation, promote the local immune system, combat immunosenescence, and promote the healing of epidermal lesions. The objective was to evaluate the effect of a cream (Alantel) based on natural products at high concentrations for the preventive and curative treatment (at early stages) of radiation-induced dermatitis in patients with breast cancer.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Our protocol is an experimental, prospective, triple-blind, multicenter, controlled clinical trial with two parallel arms. The experimental group will be treated with Alantel, while the control group will receive another moisturizing cream. Radiotherapy oncology professionals will recruit a total of 88 patients (44 per comparison group) with breast cancer who will receive radiotherapy oncology treatment for 15\u00a0days, and they will be randomly allocated to the experimental or control group. Selected patients will be followed up for four visits by primary care physicians for up to 1\u00a0week after completion of radiotherapy. The main study variable will be the incidence rate of mild post-radiation dermatitis. An intention-to-treat analysis will be performed, applying a comparison test for independent means and proportions. A bivariate and multivariate analysis will also be developed to check the treatment effect, adjusting for predictive sociodemographic and clinical variables.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>By carrying out this clinical trial, it is expected to verify that Alantel cream, based on natural products at high concentrations, has advantages over a moisturizing cream for the preventive and curative treatment of RD in patients with breast cancer. The COVID-19 pandemic has been influenced by delaying the start of the study. One of the main limitations of this study will be the time required to recruit the patients from the planned sample, given that the selection criteria are restrictive and, although the study is multicenter, recruitment will be coordinated through a single service on radiotherapy oncology.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      ClinicalTrials.gov\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04116151\">NCT04116151<\/jats:ext-link>\n                      . Registered on 4 October 2019.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13063-024-07901-8","type":"journal-article","created":{"date-parts":[[2024,1,25]],"date-time":"2024-01-25T04:02:07Z","timestamp":1706155327000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Efficacy of an aloe vera, chamomile, and thyme cosmetic cream for the prophylaxis and treatment of mild dermatitis induced by radiation therapy in breast cancer patients: a controlled clinical trial (Alantel Trials)"],"prefix":"10.1186","volume":"25","author":[{"given":"Celia","family":"Jimenez-Garcia","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8784-4905","authenticated-orcid":false,"given":"Luis Angel","family":"Perula-de Torres","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Enrique","family":"Villegas-Becerril","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan Jose","family":"Mu\u00f1oz-Gavilan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Espinosa-Calvo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gertrudis","family":"Montes-Redondo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Esperanza","family":"Romero-Rodriguez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"Alantel Trial Collaborative Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Carmen Moreno","family":"Manzanaro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fatima Gin\u00e9s","family":"Santiago","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carmen Bueno","family":"Serrano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabiola Romero","family":"Ruperto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Cruz Linares","family":"Ramirez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Angeles Quesada","family":"Rom\u00e1n","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nieves Mu\u00f1oz","family":"Alcaraz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan Manuel Parras","family":"Rejano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Isabel Lopez","family":"Estepa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Dolores","family":"Maestre-Serrano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jaime Monserrat","family":"Villatoro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,1,25]]},"reference":[{"issue":"4","key":"7901_CR1","doi-asserted-by":"publisher","first-page":"S28, S30","DOI":"10.12968\/bjon.2014.23.Sup2.S28","volume":"23","author":"D Glover","year":"2014","unstructured":"Glover D, Harmer V. Radiotherapy-induced skin reactions: assessment and management. Br J Nurs. 2014;23(4):S28, S30\u20135. https:\/\/doi.org\/10.12968\/bjon.2014.23.Sup2.S28.","journal-title":"Br J Nurs"},{"key":"7901_CR2","unstructured":"The society and college of radiographers. Practice guidelines. Radiation dermatitis guidelines for radiotherapy healthcare professionals. Second revised edition. 2020. https:\/\/www.sor.org\/learning-advice\/professional-body-guidance-and-publications\/documents-and-publications\/policy-guidance-document-library\/radiation-dermatitis-guidelines-for-radiotherapy-h.\u00a0Review date: 2025. ISBN: 978\u20131\u2013909802\u201349\u20130."},{"issue":"12","key":"7901_CR3","doi-asserted-by":"publisher","first-page":"1556","DOI":"10.1001\/archderm.141.12.1556","volume":"141","author":"AB Gutman","year":"2005","unstructured":"Gutman AB, Kligman AM, Sciacca J, James WD. Soak and smear: a standard technique revisited. Arch Dermatol. 2005;141(12):1556\u20139. https:\/\/doi.org\/10.1001\/archderm.141.12.1556.","journal-title":"Arch Dermatol"},{"key":"7901_CR4","doi-asserted-by":"publisher","first-page":"273","DOI":"10.1111\/j.1525-1470.2009.00911.x","volume":"26","author":"C Chiang","year":"2009","unstructured":"Chiang C, Eichenfield LF. Quantitative assessment of combination bathing and moisturizing regimens on skin hydration in atopic dermatitis. Pediatr Dermatol. 2009;26:273\u20138. https:\/\/doi.org\/10.1111\/j.1525-1470.2009.00911.x.","journal-title":"Pediatr Dermatol"},{"key":"7901_CR5","doi-asserted-by":"publisher","first-page":"590","DOI":"10.1111\/j.1525-1470.2012.01809.x","volume":"29","author":"E Simpson","year":"2012","unstructured":"Simpson E, Trookman NS, Rizer RL, Preston N, Colon LE, Johnson LA, et al. Safety and tolerability of a body wash and moisturizer when applied to infants and toddlers with a history of atopic dermatitis: results from an open-label study. Pediatr Dermatol. 2012;29:590\u20137. https:\/\/doi.org\/10.1111\/j.1525-1470.2012.01809.x.","journal-title":"Pediatr Dermatol"},{"key":"7901_CR6","doi-asserted-by":"publisher","first-page":"395","DOI":"10.3109\/02841869109092392","volume":"30","author":"AG Maiche","year":"1991","unstructured":"Maiche AG, Gr\u00f6hn P, M\u00e4ki-Hokkonen H. Effect of chamomile cream and almond ointment on acute radiation skin reaction. Acta Oncol. 1991;30:395\u20136. https:\/\/doi.org\/10.3109\/02841869109092392.","journal-title":"Acta Oncol"},{"key":"7901_CR7","doi-asserted-by":"publisher","first-page":"237","DOI":"10.1188\/04.ONF.237-247","volume":"31","author":"MM Wickline","year":"2004","unstructured":"Wickline MM. Prevention and treatment of acute radiation dermatitis: a literature review. Oncol Nurs Forum. 2004;31:237\u201347. https:\/\/doi.org\/10.1188\/04.ONF.237-247.","journal-title":"Oncol Nurs Forum"},{"key":"7901_CR8","doi-asserted-by":"publisher","first-page":"e345","DOI":"10.3747\/co.20.1356","volume":"20","author":"P Haddad","year":"2013","unstructured":"Haddad P, Amouzgar-Hashemi F, Samsami S, Chinichian S, Oghabian MA. Aloe vera for prevention of radiation-induced dermatitis: a self-controlled clinical trial. Curr Oncol. 2013;20:e345\u20138. https:\/\/doi.org\/10.3747\/co.20.1356.","journal-title":"Curr Oncol"},{"key":"7901_CR9","doi-asserted-by":"publisher","first-page":"1926","DOI":"10.1111\/jan.12955","volume":"72","author":"EB Ferreira","year":"2016","unstructured":"Ferreira EB, Ciol MA, Vasques CI, Bontempo PDS, Vieira NN, Silva LF, Avelino SR, Dos Santos MA, Dos Reis PE. Gel of chamomile vs. urea cream to prevent acute radiation dermatitis in patients with head and neck cancer: a randomized controlled trial. J Adv Nurs. 2016;72:1926\u201334. https:\/\/doi.org\/10.1111\/jan.12955.","journal-title":"J Adv Nurs."},{"key":"7901_CR10","doi-asserted-by":"publisher","first-page":"329","DOI":"10.12968\/bjon.2019.28.6.329","volume":"28","author":"S Woodward","year":"2019","unstructured":"Woodward S. Moisture-associated skin damage: use of a skin protectant containing manuka honey. Br J Nurs. 2019;28:329\u201335. https:\/\/doi.org\/10.12968\/bjon.2019.28.6.329.","journal-title":"Br J Nurs"},{"key":"7901_CR11","doi-asserted-by":"publisher","first-page":"608","DOI":"10.1055\/a-0835-6806","volume":"85","author":"J Seiwerth","year":"2019","unstructured":"Seiwerth J, Tasiopoulou G, Hoffmann J, W\u00f6lfle U, Schwabe K, Quirin KW, Schempp CM. Anti-inflammatory effect of a novel topical herbal composition (VEL-091604) consisting of gentian root, licorice root and willow bark extract. Planta Med. 2019;85:608\u201314. https:\/\/doi.org\/10.1055\/a-0835-6806.","journal-title":"Planta Med"},{"key":"7901_CR12","doi-asserted-by":"publisher","first-page":"345","DOI":"10.1016\/s0360-3016(96)00320-3","volume":"36","author":"MS Williams","year":"1996","unstructured":"Williams MS, Burk M, Loprinzi CL, et al. Phase III double-blind evaluation of an aloe vera gel as a prophylactic agent for radiationinduced skin toxicity. Int J Radiat Oncol Biol Phys. 1996;36:345\u20139. https:\/\/doi.org\/10.1016\/s0360-3016(96)00320-3.","journal-title":"Int J Radiat Oncol Biol Phys"},{"key":"7901_CR13","doi-asserted-by":"publisher","first-page":"45","DOI":"10.1186\/1748-717X-2-45","volume":"2","author":"TE Merchant","year":"2007","unstructured":"Merchant TE, Bosley C, Smith J, et al. A phase III trial comparing an anionic phospholipid-based cream and aloe vera-based gel in the prevention of radiation dermatitis in pediatric patients. Radiat Oncol. 2007;2:45. https:\/\/doi.org\/10.1186\/1748-717X-2-45.","journal-title":"Radiat Oncol"},{"key":"7901_CR14","doi-asserted-by":"publisher","first-page":"1307","DOI":"10.1016\/s0360-3016(00)00782-3","volume":"48","author":"J Fisher","year":"2000","unstructured":"Fisher J, Scott C, Stevens R, et al. Randomized phase III study comparing best supportive care to biafine as a prophylactic agent for radiationinduced skin toxicity for women undergoing breast irradiation: radiation therapy oncology group (RTOG) 97\u201313. Int J Radiat Oncol Biol Phys. 2000;48:1307\u201310. https:\/\/doi.org\/10.1016\/s0360-3016(00)00782-3.","journal-title":"Int J Radiat Oncol Biol Phys"},{"key":"7901_CR15","doi-asserted-by":"publisher","first-page":"641","DOI":"10.1586\/17512433.2013.841079","volume":"6","author":"CF Meghrajani","year":"2013","unstructured":"Meghrajani CF, Co HCS, Ang-Tiu CMU, et al. Topical corticosteroid therapy for the prevention of acute radiation dermatitis: a systematic review of randomized controlled trials. Expert Rev Clin Pharmacol. 2013;6:641\u20139. https:\/\/doi.org\/10.1586\/17512433.2013.841079.","journal-title":"Expert Rev Clin Pharmacol"},{"key":"7901_CR16","doi-asserted-by":"publisher","first-page":"165","DOI":"10.1080\/15569520600860009","volume":"25","author":"G Primavera","year":"2006","unstructured":"Primavera G, Carrera M, Berardesca E, et al. A double-blind, vehiclecontrolled clinical study to evaluate the efficacy of MAS065D (XClair), a hyaluronic acid-based formulation, in the management of radiationinduced dermatitis. Cutan Ocul Toxicol. 2006;25:165\u201371. https:\/\/doi.org\/10.1080\/15569520600860009.","journal-title":"Cutan Ocul Toxicol"},{"key":"7901_CR17","doi-asserted-by":"publisher","first-page":"333","DOI":"10.1016\/s0167-8140(00)00322-4","volume":"58","author":"I Roy","year":"2001","unstructured":"Roy I, Fortin A, Larochelle M. The impact of skin washing with water and soap during breast irradiation: a randomized study. Radiother Oncol. 2001;58:333\u20139. https:\/\/doi.org\/10.1016\/s0167-8140(00)00322-4.","journal-title":"Radiother Oncol"},{"key":"7901_CR18","unstructured":"RTOG\/EORTC late radiation morbidity scoring schema.\u00a0Clinical trials. https:\/\/www.rtog.org\/Clinical-Trials."},{"issue":"118","key":"7901_CR19","doi-asserted-by":"publisher","first-page":"5","DOI":"10.1016\/S0025-7753(02)72266-5","volume":"19","author":"M Jones-Caballero","year":"2002","unstructured":"Jones-Caballero M, Pe\u00f1as PF, Garc\u00eda-D\u00edez A, Chren MM, Bad\u00eda X. La versi\u00f3n espa\u00f1ola de Skindex-29. Un instrumento de medida de la calidad de vida en pacientes con enfermedades cut\u00e1neas. Med Clin (Barc). 2002;19(118):5\u20139. https:\/\/doi.org\/10.1016\/S0025-7753(02)72266-5.","journal-title":"Med Clin (Barc)"},{"key":"7901_CR20","doi-asserted-by":"publisher","first-page":"e15174","DOI":"10.1097\/MD.0000000000015174","volume":"98","author":"S Shin","year":"2019","unstructured":"Shin S, Jang BH, Suh HS, Park SH, Lee JW, Yoon SW, Kong M, Lim YJ, Hwang DS. Effectiveness, safety, and economic evaluation of topical application of a herbal ointment, Jaungo, for radiation dermatitis after breast conserving surgery in patients with breast cancer (GREEN study): Study protocol for a randomized controlled trial. Medicine (Baltimore). 2019;98:e15174. https:\/\/doi.org\/10.1097\/MD.0000000000015174.","journal-title":"Medicine (Baltimore)"}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-024-07901-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13063-024-07901-8\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-024-07901-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,1,25]],"date-time":"2024-01-25T04:06:13Z","timestamp":1706155573000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-024-07901-8"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,1,25]]},"references-count":20,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2024,12]]}},"alternative-id":["7901"],"URL":"https:\/\/doi.org\/10.1186\/s13063-024-07901-8","relation":{"has-preprint":[{"id-type":"doi","id":"10.21203\/rs.3.rs-2631518\/v1","asserted-by":"object"}]},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,1,25]]},"assertion":[{"value":"28 March 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"1 January 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"25 January 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The Clinical Research and Ethics Committee of the Reina Sofia Hospital in Cordoba (Spain) approved the protocol for this clinical trial (reference number 4430, dated 03\/12\/2019). Signed written informed consent from each participant was obtained following the general recommendations of the Helsinki Declaration. All participants were informed about the purpose of the study and the risks and benefits. Confidentiality of the participants\u2019 data will be guaranteed at all times under the provisions of Organic Law 3\/2018, on the Protection of Personal Data and the Guarantee of Digital Rights, Law 14\/2007r, on Biomedical Research, and Regulation 2016\/679 of the European Parliament and of the Council on the General Protection of Personal Data about the processing of personal data and the free movement of such data.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Enrique Villegas Becerril claims to be one of the inventors of the Alantel\u00a9 cream. The remaining authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"84"}}