{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T01:08:02Z","timestamp":1790816882367,"version":"4.1.0"},"reference-count":48,"publisher":"BMJ","issue":"4","license":[{"start":{"date-parts":[[2024,4,23]],"date-time":"2024-04-23T00:00:00Z","timestamp":1713830400000},"content-version":"unspecified","delay-in-days":22,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2024,4,3]]},"published-print":{"date-parts":[[2024,4]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Hand\u2013foot syndrome, also known as palmar\u2013plantar erythrodysesthesia (PPE), is a complication caused by chemotherapy. Clinically, it manifests as erythema and oedema on the palms of the hands and feet, dry and scaly skin, accompanied by a sensation of tightness and pain. Extreme cases have blisters and ulcerations that may require hospitalisation and\/or pause in cancer treatment. It can also be accompanied by paraesthesia. Considering the characteristics, photobiomodulation (PBM) may reduce the PPE effects. The objective of this protocol will be to evaluate the efficacy of PBM in reducing PPE induced by capecitabine and 5-fluorouracil chemotherapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>\n                      This will be a randomised controlled, double-blind, double-centre clinical trial (Centro Asistencial del Sindicato M\u00e9dico del Uruguay and Instituto Nacional del C\u00e1ncer from Uruguay). The sample population (40 individuals) will be divided into two groups: group 1 will receive moisturising cream plus PBM treatment and group 2 moisturising cream plus PBM sham treatment, at the ratio of 1:1. PBM will be performed at 630\u2009nm two times per week in palmoplantar areas of the hands and feet (4 J\/cm\n                      <jats:sup>2<\/jats:sup>\n                      ), for 4 weeks. The PPE degree and the data referring to the chemotherapy treatment plan will be measured, prior to the start of treatment in the middle and at the end of it. Quality of life questionnaires will be applied at the beginning of the trial and at the end of treatment. The data will be analysed based on the intention-to-treat analysis and \u03b1&lt;0.05\u2009will be considered statistically significant.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The protocol was approved by the Research Ethics Committee of Universidad Cat\u00f3lica del Uruguay (220316b), of Centro Asistencial del Sindicato M\u00e9dico del Uruguay (221989) and of Instituto Nacional del C\u00e1ncer (2023-04). The recruitment has already started (March 2023). Protocol version: V.2, 27 October 2023.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      ClinicalTrials.gov Registry (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial results\" xlink:href=\"NCT05337423\">NCT05337423<\/jats:ext-link>\n                      ).\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-081459","type":"journal-article","created":{"date-parts":[[2024,4,24]],"date-time":"2024-04-24T03:36:00Z","timestamp":1713929760000},"page":"e081459","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["Photobiomodulation in the treatment of palmar\u2013plantar erythrodysesthesia: a randomised controlled clinical study protocol"],"prefix":"10.1136","volume":"14","clinical-trial-number":[{"clinical-trial-number":"nct05337423","registry":"10.18810\/clinical-trials-gov","type":"results"},{"clinical-trial-number":"nct05337423","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8687-2234","authenticated-orcid":false,"given":"Valentina","family":"Lestido","sequence":"first","affiliation":[{"name":"Uninove, Sao Paulo, Brazil"},{"name":"Universidad Catolica del Uruguay, Montevideo, Uruguay"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3602-5915","authenticated-orcid":false,"given":"Florencia","family":"Rodr\u00edguez","sequence":"additional","affiliation":[{"name":"CASMU, Montevideo, Uruguay"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-7277-2691","authenticated-orcid":false,"given":"Agust\u00edn","family":"Rodr\u00edguez","sequence":"additional","affiliation":[{"name":"CASMU, Montevideo, Uruguay"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-8499-0183","authenticated-orcid":false,"given":"Valeria","family":"Pombo","sequence":"additional","affiliation":[{"name":"Instituto Nacional del Cancer, Montevideo, Uruguay"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-1731-7774","authenticated-orcid":false,"given":"Romina","family":"Barrios","sequence":"additional","affiliation":[{"name":"Instituto Nacional del Cancer, Montevideo, Uruguay"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8275-7370","authenticated-orcid":false,"given":"Christiane","family":"Pavani","sequence":"additional","affiliation":[{"name":"Uninove, Sao Paulo, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2024,4,23]]},"reference":[{"key":"2025121409132618000_14.4.e081459.1","doi-asserted-by":"crossref","first-page":"712","DOI":"10.1016\/j.clindermatol.2020.06.007","article-title":"Adverse cutaneous reactions to chemotherapeutic drugs","volume":"38","author":"Haynes","year":"2020","journal-title":"Clin Dermatol"},{"key":"2025121409132618000_14.4.e081459.2","article-title":"Pegylated liposomal doxorubicin for Relapsed epithelial ovarian cancer","volume":"7","author":"Newhouse","year":"2023","journal-title":"Cochrane Database Syst Rev"},{"key":"2025121409132618000_14.4.e081459.3","doi-asserted-by":"crossref","first-page":"208","DOI":"10.4103\/ijp.ijp_175_21","article-title":"Hand\u2013foot syndrome induced by chemotherapy drug: case series study and literature review","volume":"54","author":"Zaiem","year":"2022","journal-title":"Indian J Pharmacol"},{"key":"2025121409132618000_14.4.e081459.4","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2014.03.019"},{"key":"2025121409132618000_14.4.e081459.5","doi-asserted-by":"publisher","DOI":"10.1080\/14740338.2016.1238067"},{"key":"2025121409132618000_14.4.e081459.6","doi-asserted-by":"publisher","DOI":"10.4081\/oncol.2020.442"},{"key":"2025121409132618000_14.4.e081459.7","doi-asserted-by":"publisher","DOI":"10.1634\/theoncologist.2008-0131"},{"key":"2025121409132618000_14.4.e081459.8","doi-asserted-by":"crossref","first-page":"539","DOI":"10.1188\/20.ONF.539-556","article-title":"ONS guidelinesTM for CAnCer treatment-related skin toxicity","volume":"47","author":"Williams","year":"2020","journal-title":"Oncol Nurs Forum"},{"key":"2025121409132618000_14.4.e081459.9","doi-asserted-by":"crossref","unstructured":"Ramasubbu MK , Maji S , Padhan M , et al . 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