E. Villegas-Becerril , C. Jimenez-Garcia , L.A. Perula-de Torres , M. Espinosa-Calvo , C.M. Bueno-Serrano , F. Romero-Ruperto , F. Gines-Santiago , M.C. Moreno-Manzanaro , J.J. Muñoz-Gavilan , G. Montes-Redondo , M.A. Quesada-Roman , M.C. Linares-Ramirez , J.M. Parras-Rejano , N. Muñoz-Alcaraz , M.D. Maestre-Serrano , E.M. Romero-Rodriguez
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The objective was to evaluate the efficacy of a NPs-based cream (Alantel®) to reduce the incidence of RD in women with breast cancer undergoing RT treatment.</p></div><div><h3>Design</h3><p>We conducted a controlled, randomized, double-blind clinical trial.</p></div><div><h3>Setting</h3><p>Radiation Oncology Unit of the Reina Sofía Hospital and 5 Primary Care centers of the Cordoba and Guadalquivir Health District (Spain).</p></div><div><h3>Interventions</h3><p>Patients assigned to the experimental group (GTA) were treated with Alantel, while those in the control group (GTE) were treated with a moisturizer and emollient cream.</p></div><div><h3>Main outcome measures</h3><p>The primary outcome variable was the incidence of RD. RD-free time, duration of RD, quality of life, and product safety were also assessed.</p></div><div><h3>Results</h3><p>Seventy patients were included in the study, 35 in the GTA and 35 in the GTE. The incidence of RD was lower in the GTA (71.4%) than in the GTE (91.4%) after 4 weeks of follow-up (RR = 0.78; NNT = 5; p < 0.031). The Skindex-29 questionnaire showed differences in the statement: “My skin condition makes it hard to work or do hobbies” (17.1% in the GTE vs. 2.9% in GTA; p = 0.024).</p></div><div><h3>Conclusions</h3><p>The higher efficacy of Alantel® compared to the control cream in reducing the incidence of RD in women with breast cancer has been demonstrated.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"39 ","pages":"Article 101288"},"PeriodicalIF":1.4000,"publicationDate":"2024-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000358/pdfft?md5=c8d41cabdf9462fe99d98e949a888f2e&pid=1-s2.0-S2451865424000358-main.pdf","citationCount":"0","resultStr":"{\"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 (the Alantel study)\",\"authors\":\"E. 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The objective was to evaluate the efficacy of a NPs-based cream (Alantel®) to reduce the incidence of RD in women with breast cancer undergoing RT treatment.</p></div><div><h3>Design</h3><p>We conducted a controlled, randomized, double-blind clinical trial.</p></div><div><h3>Setting</h3><p>Radiation Oncology Unit of the Reina Sofía Hospital and 5 Primary Care centers of the Cordoba and Guadalquivir Health District (Spain).</p></div><div><h3>Interventions</h3><p>Patients assigned to the experimental group (GTA) were treated with Alantel, while those in the control group (GTE) were treated with a moisturizer and emollient cream.</p></div><div><h3>Main outcome measures</h3><p>The primary outcome variable was the incidence of RD. RD-free time, duration of RD, quality of life, and product safety were also assessed.</p></div><div><h3>Results</h3><p>Seventy patients were included in the study, 35 in the GTA and 35 in the GTE. 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The Skindex-29 questionnaire showed differences in the statement: “My skin condition makes it hard to work or do hobbies” (17.1% in the GTE vs. 2.9% in GTA; p = 0.024).</p></div><div><h3>Conclusions</h3><p>The higher efficacy of Alantel® compared to the control cream in reducing the incidence of RD in women with breast cancer has been demonstrated.</p></div>\",\"PeriodicalId\":37937,\"journal\":{\"name\":\"Contemporary Clinical Trials Communications\",\"volume\":\"39 \",\"pages\":\"Article 101288\"},\"PeriodicalIF\":1.4000,\"publicationDate\":\"2024-04-02\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S2451865424000358/pdfft?md5=c8d41cabdf9462fe99d98e949a888f2e&pid=1-s2.0-S2451865424000358-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Contemporary Clinical Trials Communications\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2451865424000358\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary Clinical Trials Communications","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2451865424000358","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
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 (the Alantel study)
Objectives
Radiation-induced dermatitis (RD) is one of the most common toxicities in radiation therapy (RT) patients. Corticosteroids, immunosuppressants, and natural products (NPs) have been used as treatment. The objective was to evaluate the efficacy of a NPs-based cream (Alantel®) to reduce the incidence of RD in women with breast cancer undergoing RT treatment.
Design
We conducted a controlled, randomized, double-blind clinical trial.
Setting
Radiation Oncology Unit of the Reina Sofía Hospital and 5 Primary Care centers of the Cordoba and Guadalquivir Health District (Spain).
Interventions
Patients assigned to the experimental group (GTA) were treated with Alantel, while those in the control group (GTE) were treated with a moisturizer and emollient cream.
Main outcome measures
The primary outcome variable was the incidence of RD. RD-free time, duration of RD, quality of life, and product safety were also assessed.
Results
Seventy patients were included in the study, 35 in the GTA and 35 in the GTE. The incidence of RD was lower in the GTA (71.4%) than in the GTE (91.4%) after 4 weeks of follow-up (RR = 0.78; NNT = 5; p < 0.031). The Skindex-29 questionnaire showed differences in the statement: “My skin condition makes it hard to work or do hobbies” (17.1% in the GTE vs. 2.9% in GTA; p = 0.024).
Conclusions
The higher efficacy of Alantel® compared to the control cream in reducing the incidence of RD in women with breast cancer has been demonstrated.
期刊介绍：
Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.
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