Photobiomodulation in the treatment of palmar-plantar erythrodysesthesia: a randomised controlled clinical study protocol.

INTRODUCTION: Hand-foot syndrome, also known as palmar-plantar 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. METHODS AND ANALYSIS: This will be a randomised controlled, double-blind, double-centre clinical trial (Centro Asistencial del Sindicato Médico del Uruguay and Instituto Nacional del Cáncer 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 nm two times per week in palmoplantar areas of the hands and feet (4 J/cm2), 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 α<0.05 will be considered statistically significant. ETHICS AND DISSEMINATION: The protocol was approved by the Research Ethics Committee of Universidad Católica del Uruguay (220316b), of Centro Asistencial del Sindicato Médico del Uruguay (221989) and of Instituto Nacional del Cáncer (2023-04). The recruitment has already started (March 2023). PROTOCOL VERSION: V.2, 27 October 2023. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT05337423).

Tratamiento del cáncer de canal anal. Descripción de técnica y resultados de tratamiento radiante con o sin quimioterapia. Estudio retrospectivo en una población no seleccionada (1988 - 2016) / Treatment of cancer of the anal canal. Description of technique and results of radiation therapy with or without chemotherapy. Retrospective study in a non-selected population (1988 - 2016) / Tratamento do câncer de canal anal. Descrição de técnica e resultados de tratamento radiante comou sem quimioterapia. Estudo retrospectivo em uma população não selecionada (1988 - 2016)

Introducción: el cáncer de canal anal representa aproximadamente un 2% a 3% de todas las neoplasias digestivas. Nigro describió el tratamiento conservador del cáncer de canal anal utilizando radioterapia y quimioterapia con 5-fluorouracilo (5-FU) y mitomicina C (MMC), desde entonces este tratamiento es estándar. Objetivo: describir la técnica utilizada en nuestro servicio y los resultados en el control locorregional del cáncer de canal anal. Método: descriptivo, longitudinal, retrospectivo. Se analizaron historias de 72 pacientes consecutivos sin exclusiones, portadores de cáncer de canal anal, entre 1988 y 2016. El 67% recibió radioquimioterapia y el 33% de los pacientes radioterapia exclusiva por presentar contraindicaciones médicas específicas y fueron analizados en su conjunto. No se planificaron interrupciones en los tratamientos. Las interrupciones obligatorias fueron de 1 a 17 días con una media de 3 días. Las reacciones agudas fueron moderadas y no se comprobaron complicaciones tardías. Todos recibieron radioterapia locorregional. Resultados: el control local en N0 fue de 86% en T1 y T2 versus 42% en T3 y T4 a seis años, p=0,01 significativo. Conclusiones: la radioterapia con la técnica utilizada en nuestro servicio es efectiva en el tratamiento del cáncer de canal anal. La recidiva local ha sido la causa principal de persistencia lesional o recidiva. La curabilidad de la enfermedad está en relación directa con la extensión clínica/imagenológica de la lesión local.

Introduction: cancer of the anal canal accounts for approximately 2 to 3% of all digestive neoplasms. Nigro described the conservative treatment of cancer of the anal canal using radiation and chemotherapy of 5-fluorouracil (5-FU) and mitomycin-C (MMC). Since then, this is the standard therapy. Objective: to describe the technique used in our service and its results in the locoregional follow up of cancer of the anal canal. Method: descriptive, longitudinal, retrospective. The medical history of 72 consecutive patients with no exclusions, who were carriers of cancer of the anal canal were analysed between 1988 and 2016. 67% underwent radiation and chemotherapy and 33% only radiation therapy due to specific medical contraindications. All cases were comprehensively studied and no interruption of treatments were planned. Mandatory interruptions were from 1 to 17 days long and average length was 3 days. Severe reactions were moderate and no late complications were seen. All patients underwent locoregional radiation therapy. Results: local control in N0 was 86% in T1 and T2 versus 42% in T3 and T4 after 6 years p=0,01 meaningful. Conclusions: radiation therapy with the technique used in our service is effective to treat cancer of the anal canal. Local relapse has been the main cause of lesions or relapse. Curability of the disease is directly linked to the clinical/imaging extent of the local lesion.

Introdução: o câncer de canal anal representa aproximadamente 2 a 3% das neoplasias digestivas. Nigro descreveu o tratamento conservador do câncer de canal anal utilizando radioterapia e quimioterapia com 5-Fluorouracilo (5-FU) e Mitomicina C (MMC) que tem sido o tratamento padrão. Objetivo: descrever a técnica utilizada no nosso serviço e os resultados do controle locorregional do câncer de canal anal. Método: descritivo, longitudinal, retrospectivo. Foram analisados os prontuários de 72 pacientes consecutivos sem exclusões, portadores de câncer de canal anal, do período 1988-2016. 67% receberam radio quimioterapia e 33% radioterapia exclusivamente devido a contraindicações médicas específicas; os resultados foram analisados conjuntamente. Não se planejou interrupções nos tratamentos. As interrupções obrigatórias foram de 1 a 17 dias com uma média de 3 dias. As reações agudas foram moderadas e não se comprovaram complicações tardias. Todos receberam radioterapia locorregional. Resultados: o controle local em N0 foi de 86% em T1 e T2 versus 42% em T3 e T4 a 6 anos p=0,01 significativo. Conclusões: a radioterapia com a técnica utilizada no nosso Serviço é efetiva no tratamento do câncer de canal anal. A recidiva local foi a causa principal de persistência lesional ou recidiva. A curabilidade da enfermidade está diretamente relacionada com a extensão clínica e das imagens da lesão local.