RESUMO
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).
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Síndrome Mão-Pé , Terapia com Luz de Baixa Intensidade , Ensaios Clínicos Controlados Aleatórios como Assunto , Humanos , Método Duplo-Cego , Síndrome Mão-Pé/etiologia , Terapia com Luz de Baixa Intensidade/métodos , Fluoruracila/efeitos adversos , Qualidade de Vida , Capecitabina/uso terapêutico , Capecitabina/efeitos adversos , Estudos Multicêntricos como AssuntoRESUMO
Hand-foot syndrome (HFS) is a common adverse effect of anticancer therapy. It is known to cause dermatological symptoms including acral erythema and dysesthesia of the palms and soles of the feet, swelling, pain, itching, and scaling. Some drugs, like capecitabine, are known to trigger this condition. However, pigmentation of the oral mucosa is a rare adverse effect. This study aims to report a case of oral mucosa hyperpigmentation caused by capecitabine therapy before the clinical diagnosis of HFS. A 58-year-old female, diagnosed with invasive breast duct carcinoma, had the central nervous system, liver, skin, and lung metastasis, using capecitabine every day for 14 cycles. Oral examination revealed multifocal black macules on the hard palate, bilateral buccal mucosa, gingival mucosa, and dorsum of the tongue. The clinical hypothesis was oral mucosa hyperpigmentation by capecitabine use and only periodic follow-up was necessary. Hyperpigmentation of oral mucosa by capecitabine is a rare consequence of neoplastic therapy and your association with HFS is unclear, and poorly reported. The report of these events is important to alert oncology health teams about the individual tolerance to capecitabine therapy.
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Síndrome Mão-Pé , Hiperpigmentação , Antimetabólitos Antineoplásicos/efeitos adversos , Capecitabina/efeitos adversos , Desoxicitidina/efeitos adversos , Feminino , Fluoruracila/efeitos adversos , Síndrome Mão-Pé/etiologia , Humanos , Hiperpigmentação/induzido quimicamente , Hiperpigmentação/complicações , Pessoa de Meia-IdadeRESUMO
BACKGROUND: Hand-foot syndrome (HFS) is a specific adverse effect of certain chemotherapy that may lead to dosage reduction or chemotherapy discontinuation in patients with cancer. Topical urea cream may reduce symptom severity in patients with HFS. However, these studies have not provided consonant results. OBJECTIVE: To determine the effectiveness of urea cream, we conducted a meta-analysis of clinical trials to evaluate the prevention and treatment of HFS. METHODS: PubMed, EMBASE, and Cochrane Library databases were searched for studies published before September 2020. The study registered at PROSPERO (CRD 42020203164). Incidence of HFS reported in studies at any grade and at second grade or greater was assessed within 3 to 12 weeks. Secondary outcomes were time to HFS, incidence of skin-related adverse events, chemotherapy dose reduction, and quality of life. RESULTS: Seven trials involving 1387 patients were reviewed. In the prophylactic subgroup, patients with urea cream intervention showed a significantly lower incidence of HFS at second grade or greater (risk ratio, 0.72; 95% confidence interval, 0.58-0.90) and a nonsignificant lower incidence of any-grade HFS (risk ratio, 0.79; 95% confidence interval, 0.58-1.08) than those not receiving urea cream intervention. CONCLUSIONS: Urea cream has advantages to reduce the incidence of severe HFS. IMPLICATIONS FOR PRACTICE: Urea cream is a safe and viable topical prevention strategy that can reduce the incidence of high-grade HFS in patients undergoing chemotherapy. We recommend a routine treatment option before chemotherapy for the patients.
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Síndrome Mão-Pé , Neoplasias , Síndrome Mão-Pé/tratamento farmacológico , Síndrome Mão-Pé/etiologia , Síndrome Mão-Pé/prevenção & controle , Humanos , Incidência , Neoplasias/complicações , Neoplasias/tratamento farmacológico , Qualidade de Vida , Ureia/uso terapêuticoRESUMO
INTRODUCTION: This study aimed to evaluate the frequency of nail disorders and the presence of fungi on the nails of the hands and feet of patients with hand-foot syndrome secondary to treatment with paclitaxel. METHODS: Prospective study, carried out from October 2018 to December 2019, which included 81 patients undergoing treatment for breast cancer using paclitaxel and had signs and or symptoms of hand-foot syndrome with or without nail disorders. The data were collected through interviews guided by a structured questionnaire, information from medical records and reports of mycological exams. RESULTS: The average age of women was 54.7 ± 7.4 years. Nail disorders occurred in 69 patients (85.2%), and of these, 43 (62.3%) were positive for fungi. The fungi were yeasts (n = 38; 69%), dermatophytes (n = 15; 27.2%) and non-dermatophyte filamentous fungi (n = 8; 14.5%). CONCLUSIONS: Nail disorders were the most frequent manifestations in patients with hand-foot syndrome treated with paclitaxel and occurred in 85.2% of them. It was evidenced that fungi are present on the nails of these patients and can occur in up to 65.28%. The most prevalent fungi were Candida and Trichophyton. The nail lesion was associated with the type of treatment protocol used by the patient. The results of the study point to the need to select safe management alternatives for patients, so they can prevent nail lesions and prevent the proliferation of fungi, consequently reducing negative life impact during treatment.
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Síndrome Mão-Pé , Doenças da Unha , Onicomicose , Humanos , Feminino , Pessoa de Meia-Idade , Onicomicose/tratamento farmacológico , Onicomicose/diagnóstico , Onicomicose/microbiologia , Síndrome Mão-Pé/epidemiologia , Síndrome Mão-Pé/etiologia , Paclitaxel/efeitos adversos , Estudos Prospectivos , Trichophyton , Doenças da Unha/induzido quimicamente , Doenças da Unha/epidemiologiaRESUMO
INTRODUCTION: Adermatoglyphia is defined as the medical condition clinically diagnosed to those who have a congenital or acquired loss of the epidermal ridges on the fingertips, commonly known as fingerprints. Capecitabine, a fluoropyrimidine, is the treatment of choice in a myriad of tumors and has occasionally been reported to cause adermatoglyphia as a secondary effect upon its use. CASE REPORT: A 52-year-old female patient, diagnosed with stage IV metastatic left breast cancer with extension to bone in late 2011 reported upon biopsy a hormone receptor positive Her2 negative ductal carcinoma. After initial treatment with a combined radiotherapy and chemotherapy palliative treatment, hepatic and lung metastasis progression obliged capecitabine oral intake. In 2018, after two years on the fluoropyrimidine (capecitabine), the patient reported adermatoglyphia. MANAGEMENT & OUTCOME: The patient opted to continue taking the medication, since such treatment was working with no other meaningful side effects. Her last work-up studies continue to show complete lung and liver response with stable bone disease. DISCUSSION: Capecitabine is a common drug in the therapy against metastatic breast cancer due to its manageable safety profile. Hand-foot syndrome is a frequent side effect caused by this drug, with dosage adjustment recommended with progression of symptoms. Recent publications have reported adermatoglyphia as a rare side effect of capecitabine use. Upon further examination through dermatoscopy and biopsy, the patient was evidenced to have lost the epidermal ridges that form fingerprints. A score of 9 on the Naranjo scale confirmed to be a consequence of the administration of capecitabine.
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Neoplasias da Mama , Síndrome Mão-Pé , Protocolos de Quimioterapia Combinada Antineoplásica , Neoplasias da Mama/tratamento farmacológico , Capecitabina/efeitos adversos , Feminino , Fluoruracila/efeitos adversos , Síndrome Mão-Pé/etiologia , Humanos , Pessoa de Meia-Idade , Receptor ErbB-2RESUMO
BACKGROUND: Sarcopenia is related to poor prognosis and drug toxicities in solid tumors. The aim of our study is to investigate the predisposition of patients with metastatic colorectal carcinoma who started regorafenib treatment to sarcopenia and prolonged survival. METHODS: Patients with metastatic colorectal carcinoma who receives regorafenib were search retrospectively. Dose-limiting toxicity was defined as dose reduction or toxicity requiring drug withdrawal. Sarcopenia evaluation was made with computed tomography performed within a month before treatment. Progression-free survival and overall survival were estimated. RESULTS: Thirty-six patients were found as suitable for the study. 63.9% of patients were found as basally sarcopenic. Dose-limiting toxicity occured 13 of 23 patients (56.5%) with basal sarcopenia, whereas only 1 of 13 patients (7.6%) with no sarcopenia exhibited dose-limiting toxicity (p = 0.005). Three patients suffered from grade 3-4 toxicity. Hand-foot syndrome, hypertension, and mucosal rash were the most seen side effects. Mean regorafenib treatment duration was 3.36 months. There was no significant difference in the progression-free survival (PFS) and the overall survival (OS) between sarcopenic patients and patients with no sarcopenia. Durations were as OS 24.2 weeks in patients with sarcopenia (95% CI 16.7-31.7), 28.1 weeks in patients with no sarcopenia (95% CI 20.5-35.7) (p = 0.36), and as PFS 14.2 weeks in patients with sarcopenia (95% CI 12.1-16.4), 14.8 weeks in patients with no sarcopenia (95% CI 9.7-20.1) (p = 0.65). CONCLUSION: Dose-limiting toxicity was significantly higher in basally sarcopenic patients who were started regorafenib as treatment of metastatic colorectal carcinoma. There was no significant relationship between overall survival and progression-free survival with sarcopenia.
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Neoplasias Colorretais/tratamento farmacológico , Compostos de Fenilureia/efeitos adversos , Piridinas/efeitos adversos , Sarcopenia/induzido quimicamente , Idoso , Neoplasias Colorretais/mortalidade , Neoplasias Colorretais/patologia , Suscetibilidade a Doenças , Exantema/induzido quimicamente , Feminino , Síndrome Mão-Pé/etiologia , Humanos , Hipertensão/induzido quimicamente , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Mucosa , Compostos de Fenilureia/administração & dosagem , Intervalo Livre de Progressão , Piridinas/administração & dosagem , Estudos Retrospectivos , Sarcopenia/diagnóstico por imagem , Sarcopenia/mortalidade , Tomografia Computadorizada por Raios XAssuntos
Foliculite/induzido quimicamente , Compostos de Fenilureia/efeitos adversos , Inibidores de Proteínas Quinases/efeitos adversos , Quinolinas/efeitos adversos , Dermatopatias/induzido quimicamente , Sorafenibe/efeitos adversos , Abdome , Idoso , Carcinoma/tratamento farmacológico , Carcinoma/secundário , Carcinoma Hepatocelular/tratamento farmacológico , Foliculite/patologia , Síndrome Mão-Pé/etiologia , Humanos , Neoplasias Hepáticas/tratamento farmacológico , Masculino , Pessoa de Meia-Idade , Dermatopatias/patologia , Coxa da Perna , Neoplasias da Glândula Tireoide/tratamento farmacológico , Neoplasias da Glândula Tireoide/patologiaRESUMO
INTRODUCTION: Direct-acting antivirals are new drugs for chronic hepatitis C treatment. They are usually safe and well tolerated, but can sometimes cause serious adverse effects and there is no consensus on how to treat or prevent them. We described a case of hand-foot syndrome due to hepatitis C virus interferon-free therapy. METHODS: We report the case of a 49-year-old man with compensated liver cirrhosis due to chronic hepatitis C genotype 1, treatment-naïve, who started viral treatment with sofosbuvir, simeprevir and ribavirin for 12 weeks. RESULTS: At the sixth week of treatment he had anemia, requiring a lower dose of ribavirin. At the tenth week, he had erythematous, pruritic, scaly and flaky lesions on hands and feet, which showed a partial response to oral antihistamines and topical corticosteroids. It was not necessary to discontinue antiviral treatment, but in the first week after the end of treatment, there was worsening of injuries, including signs of secondary infection, that required hospitalization, antibiotics and oral corticosteroid, with progressive improvement. Biopsy of the lesions was consistent with pharmacodermia. The patient had sustained a virological response, despite the side effect. He had a history of pharmacodermia one year ago attributed to the use of topiramate, responsive to oral corticosteroid. CONCLUSION: Interferon-free therapies can rarely lead to severe adverse reactions, such as skin lesions. Patients receiving ribavirin combinations and those who had a history of pharmacodermia or skin disease may be more susceptible. There is no consensus on how to prevent skin reactions in these patients.