Guarana (Paullinia cupana) Improves Anorexia in Patients with Advanced Cancer.

PURPOSE: Anorexia is prevalent in cancer patients with advanced disease. In this pilot phase II, open label, nonrandomized trial, we evaluated the efficacy and safety of guarana (Paullinia cupana) in patients with cancer and weight loss. METHODS: We included advanced cancer patients with decreased appetite and weight loss of more than 5% from their baseline. All of the patients received 50 mg of the crude dry extract of guarana twice a day for 4 weeks. The trial was designed in two phases (Simon model). We considered a positive response in the first phase to be at least 5% weight gain or a three-point improvement in the appetite scale in at least three of the first 18 evaluable patients. RESULTS: Of the 34 eligible patients, 30 were included and 18 completed the protocol. Only one patient abandoned the protocol due to toxicity (grade II arthralgia). No grade 3 or 4 toxicities and no significant differences in nausea, weight loss, or quality of life (FACT-G) occurred. Only two of the 18 patients who completed the study had weight gain above 5% from their baseline, whereas six patients had at least a 3-point improvement in the visual appetite scale. The M.D. Anderson Symptom Inventory (MDASI) was used to evaluate several symptoms, and we observed a significant decrease in the lack of appetite (p = 0.02) and in somnolence (p = 0.0142). CONCLUSION: We concluded that the weight stabilization and increased appetite that we observed in this study justify further studies of guarana in this patient population.

Vitamin E for prevention of oxaliplatin-induced peripheral neuropathy: a pilot randomized clinical trial.

CONTEXT AND OBJECTIVE Oxaliplatin is one of the chemotherapy regimens most used for treating colorectal cancer. One of the main limitations to its use is induction of peripheral neuropathy. Previous studies have shown that vitamin E can reduce the incidence of peripheral neuropathy by 50%. This study aimed to assess the effectiveness of vitamin E for prevention of oxaliplatin-induced peripheral neuropathy. DESIGN AND SETTING Prospective, phase II, randomized pilot study developed at a university hospital in the Greater ABC region. METHODS Patients were randomized five days before starting oxaliplatin treatment, to receive either vitamin E or placebo until the end of the chemotherapy regimen. The outcome was evaluated using the Common Terminology Criteria for Adverse Events (CTCAE), version 3, and specific gradation scales for oxaliplatin-induced peripheral neuropathy. Patients with colorectal and gastric cancer who had been scheduled to receive oxaliplatin-based chemotherapy were included. Both groups received calcium and magnesium supplementation before and after oxaliplatin infusions. RESULTS Eighteen patients were randomized to the vitamin E group and 16 to the placebo group. Cumulative incidence of 83% with peripheral neuropathy grades 1/2 was observed in the vitamin E group, versus 68% in the placebo group (P = 0.45). A trend towards more diarrhea was observed among patients who received vitamin E (55.6% vs. 18.8%; P = 0.06). There were no other significant differences in toxicity between the groups. CONCLUSIONS No significant decrease in the incidence of acute oxaliplatin-induced peripheral neuropathy was demonstrated through vitamin E use.

Vitamin E for prevention of oxaliplatin-induced peripheral neuropathy: a pilot randomized clinical trial / Vitamina E na prevenção de neuropatia periférica induzida pela oxaliplatina: estudo clínico piloto randomizado

Oxaliplatin is one of the chemotherapy regimens most used for treating colorectal cancer. One of the main limitations to its use is induction of peripheral neuropathy. Previous studies have shown that vitamin E can reduce the incidence of peripheral neuropathy by 50%. This study aimed to assess the effectiveness of vitamin E for prevention of oxaliplatin-induced peripheral neuropathy.

Prospective, phase II, randomized pilot study developed at a university hospital in the Greater ABC region.

Patients were randomized five days before starting oxaliplatin treatment, to receive either vitamin E or placebo until the end of the chemotherapy regimen. The outcome was evaluated using the Common Terminology Criteria for Adverse Events (CTCAE), version 3, and specific gradation scales for oxaliplatin-induced peripheral neuropathy. Patients with colorectal and gastric cancer who had been scheduled to receive oxaliplatin-based chemotherapy were included. Both groups received calcium and magnesium supplementation before and after oxaliplatin infusions.

Eighteen patients were randomized to the vitamin E group and 16 to the placebo group. Cumulative incidence of 83% with peripheral neuropathy grades 1/2 was observed in the vitamin E group, versus 68% in the placebo group (P = 0.45). A trend towards more diarrhea was observed among patients who received vitamin E (55.6% vs. 18.8%; P = 0.06). There were no other significant differences in toxicity between the groups.

No significant decrease in the incidence of acute oxaliplatin-induced peripheral neuropathy was demonstrated through vitamin E use.

A oxaliplatina é um dos quimioterápicos mais utilizados no tratamento do câncer colorretal, sendo a indução da neuropatia periférica (NP) uma das principais limitações para o seu uso. Trabalhos anteriores demonstraram que a vitamina E poderia reduzir a incidência dessa neuropatia em 50%. Este estudo teve como objetivo avaliar a efetividade da vitamina E na prevenção da NP induzida pela oxaliplatina.

Estudo piloto prospectivo e randomizado de fase II desenvolvido em hospital universitário do Grande ABC.

Os pacientes foram randomizados para receber vitamina E ou placebo por cinco dias antes do início do tratamento com oxaliplatina e até o término do regime quimioterápico. O desfecho foi avaliado através dos Critérios Comuns de Toxicidade do Câncer versão 3 (CTCAE) e escalas específicas de gradação da NP induzida por oxaliplatina. Foram incluídos pacientes com câncer colorretal e gástrico programado para receber quimioterapia baseada em oxaliplatina. Ambos os grupos receberam suplementação de cálcio e magnésio antes e depois das infusões de oxaliplatina.

Dezoito pacientes foram randomizados para grupo da vitamina E e 16 para o grupo placebo. Observou-se incidência cumulativa de 83% das classes I/II de neuropatia periférica no grupo da vitamina E, contra 68% no grupo placebo (P = 0,45). Observou-se maior tendência à diarreia em pacientes que receberam vitamina E (55,6% versus 18,8%, P = 0,06). Não houve outras diferenças significativas quanto às toxicidades entre os grupos. ...

Complicated urinary infection and extrapulmonary tuberculosis.

Approximately 30% of the world population presents with tuberculosis. In developed countries, genitourinary manifestation is responsible for over 40% of extrapulmonary cases. Genitourinary tuberculosis is often diagnosed in the later stage due to the fact that the symptoms are non-specific and technical difficulties to isolate the tubercle bacillus through bacilloscopy or culture in specific medium are many. We present a case of a 47-year-old African-American woman with relapsing urinary infection and sterile pyuria. After a 4 four-year evolution, the patient developed functional exclusion of the right kidney as a consequence of chronic pyelonephritis. The investigation result for alcohol-acid bacillus resistant in urine was positive along with the culture for Mycobacterium tuberculosis.

The prevalence and influence of self-reported conflicts of interest by editorial authors of phase III cancer trials.

PURPOSE: To assess the frequency with which editorial authors report personal conflict of interest and investigate a possible association between the presence of such conflicts and favorable opinion. METHODS: Eligible studies were editorials of phase III clinical trials of antitumor drugs or symptom management published from January 2007 to December 2009 in four top oncology journals. Data from the editorials were collected and each editorial opinion was classified as favorable, neutral or unfavorable with respect to the experimental therapy. RESULTS: Fifty-four editorials were included: 23 (43%) reported at least one conflict of interest, with the most frequent one being consultancy fees. Conclusions of editorial authors were classified as favorable in 18 editorials (33%). Sensitivity analysis found an association between self-reported conflict of interest of the editorial author and editorial favorable opinion (RR:2.7; 95% CI 1.2-6.1; p=0.019). DISCUSSION: Besides the high proportion of conflict of interest among editorial authors discussing phase III clinical trials, study interpretation may be influenced by their financial relationships with industry.

Prevalência do câncer em dois serviços públicos atendidos pela Disciplina de Oncologia e Hematologia da Faculdade de Medicina da Fundação ABC (FMABC) / Cancer prevalence in two public services coordinated by the Department of Oncology and Hematology, ABC Foundation School of Medicine (FMABC)

Objetivos: Analisar as características dos pacientes que frequentam os serviços de Oncologia da FMABC e comparar com as estatísticas acionais e da região. Métodos: Trata-se de um levantamento epidemiológico conduzido de 14/9/2010 a 18/5/2011 nos ambulatórios de oncologia de dois hospitais públicos da região do grande ABC, que tabulou de forma sistemática as características clínicas dos pacientes atendidos. Resultados: Do total de 2.366 pacientes avaliados, 60% eram oriundos do Hospital Mário Covas, 63% eram mulheres, com idade média de 60,25 (12-105) anos. Os tumores mais prevalentes foram: mama (31,6%), colorretal (14,8%), próstata (11,2%), linfoma não Hodgkin (6%) e estômago (3,9%). Do total de pacientes (excetuando-se linfoma não Hodgkin), 15,3% apresentaram metástase no momento da sua inclusão. Conclusões: Em comparação com os dados do INCA para o Brasil e região Sudeste de 2010, nosso serviço apresenta significativamente mais casos de câncer de mama (31,5% FMABC versus 13% Brasil e 13,6% Sudeste) e menor número de casos de câncer de pulmão (2,5% FMABC versus 7,36% Brasil e 6,7% Sudeste). Volumes diferentes de cirurgias oncológicas nos diversos serviços de referência de nossa instituição, assim como maior intensidade de medidas preventivas para câncer de mama podem explicar parte das diferenças observadas. Não podemos excluir, todavia, fatores epidemiológicos específicos regionais para explicar a alta prevalência de câncer de mama na região do ABC.

Gabapentin for the prevention of chemotherapy- induced nausea and vomiting: a pilot study.

INTRODUCTION: Chemotherapy-induced nausea and vomiting (CINV) is a distressing side effect that affects many patients undergoing emetogenic chemotherapy, despite the use of antiemetic medications. The purpose of this trial was to evaluate the efficacy and safety of gabapentin for the prevention of CINV during the first cycle of treatment in patients receiving moderately or highly emetogenic chemotherapy. METHODS: Eighty chemotherapy-naive patients, scheduled to receive moderately and highly emetogenic chemotherapy, were enrolled in this randomised, double-blind, placebo-controlled clinical trial. All patients received intravenous ondansetron 8 mg, dexamethasone 10 mg and ranitidine 50 mg before chemotherapy on day 1 and oral dexamethasone 4 mg twice a day on days 2 and 3. Patients were randomly assigned to take gabapentin 300 mg or placebo on the following schedule: 5 and 4 days before chemotherapy once daily, 3 and 2 days before chemotherapy twice daily, 1 day before to 5 days after chemotherapy thrice daily. The primary endpoint was complete overall protection from both vomiting and nausea over the course of the entire study (day 1 through day 5), and complete protection during the delayed period (24-120 h after chemotherapy). RESULTS: The proportion of patients achieving complete response improved from 40% to 62.5%, (p = 0.04) when comparing the control group and the gabapentin group, respectively. In the subset of patients who achieved complete control in the acute phase, the percentage of patients who achieved delayed complete control was higher in the gabapentin group (89.3 × 60.7%, p = 0.01). Adverse events did not significantly differ between study arms. CONCLUSIONS: Gabapentin is a low-cost strategy to improve complete control of CINV, specially delayed CINV control.

Aplicação do instrumento termômetro de estresse em pacientes idosos com câncer: estudo piloto / Application of the distress thermometer in elderly patients with cancer: pilot study

JUSTIFICATIVA E OBJETIVOS: Evidências apontam que cerca de metade dos pacientes com câncer apresentam altos níveis de estresse, condição que ainda permanece pouco diagnosticada e tratada. Este estudo piloto visou investigar a utilização do instrumento Termômetro de Estresse (TE) aplicando-o a pacientes idosos em vigência de tratamento quimioterápico, de forma a identificar possíveis fatores preditivos de estresse nessa população. MÉTODO: Foram selecionados aleatoriamente 40 pacientes com idade igual ou superior a 65 anos, portadores de neoplasia sólida ou hematológica, em tratamento quimioterápico nos serviços vinculados à Faculdade de Medicina do ABC. Estes responderam ao TE e a questionários para avaliação de qualidade de vida, atividades da vida diária, escala de sintomas relacionados à quimioterapia, escala de depressão geriátrica, mini-exame do estado mental e mini-avaliação nutricional. RESULTADOS: A pontuação média do TE foi de 4,20, sendo que 65% dos pacientes apresentaram alto nível de estresse (pontuação de corte maior ou igual a 4). Verificou-se a correlação do TE ao Questionário de Atividades Instrumentais de Lawton (p = 0,035), à Escala de Sintomas de Edmonton (p = 0,043) e à Escala de Depressão Geriátrica (p = 0,030). CONCLUSÃO: Pacientes idosos em tratamento quimioterápico sofrem de estresse, que pode estar relacionado à diminuição da capacidade de desenvolver atividades instrumentais da vida diária, aos próprios sintomas do regime quimioterápico e à manifestação de sintomas de depressão.

BACKGROUND AND OBJECTIVES: Up to half of all cancer patients experience clinically significant levels of stress and much of this stress goes unrecognized and untreated. This pilot study aimed to evaluate the Distress Thermometer (DT) in elderly patients undergoing chemotherapy in oncology services related to the School of Medicine of ABC and to identify possible predictors. METHOD: We randomly selected 40 patients aged over 65 years with hematologic or solid tumors undergoing chemotherapy treatment. They were asked to respond to the DT and questionnaires for assessing quality of life, activities of daily living, symptoms related to chemotherapy, geriatric depression scale, mini-mental state and mini-nutritional assessment. RESULTS : Regarding the DT, the average score was 4.20 and 26 patients (65% of total) had scores above 4 (the optimal DT cutoff score). In the correlation analysis, we obtained a correlation of TD to the questionnaires of Instrumental Activities of Daily Living (p= 0.035), Edmonton Symptom Assessment Scale (p =0.043) and Geriatric Depression Scale (p=0.030). CONCLUSION: Elderly patients undergoing chemotherapy suffer from stress that can be related to the decline in their ability to develop instrumental daily activities, to the symptoms related to the chemotherapy and to the development of depression symptoms.

[How to consent without understanding?]. / Como consentir sem entender?

BACKGROUND: The Consent Form (CF) is an important document that informs patients about benefits and risks of a study, it assures patients the right to accept or reject participation in a procedure related to their health. Some authors believe that Consent Forms are complex and difficult to read for most people. OBJECTIVE: Correlate the difficulty of understanding CF, through the Flesch Index (FI) and Flesch-Kincaid Index (FKI), used in our oncology outpatient clinic, with the profile of our patient's education. We also wanted to verify readability and presence of the information which must be part of these CF according to item IV.1 from Resolution 196/96 of the Brazilian Health Council. RESULTS: We obtained 10 CFs, according to FI and FKI the mean was 38.5 and 18.16 respectively, indicating that, at least, 18 years of study are needed for the comprehension. This result is incompatible with the Brazilian population where more than 50% have less than 8 years of study. According to the quality of the CF, they were well elaborated, and had most of the necessary contents. When the authors correlated FKI and quality of CF, they concluded that the quality of CF does not correlate with readability (p= 0.884, Pearson correlation coefficients 0.053). CONCLUSION: Despite the good content quality of most of the analyzed CF, their level of reading difficulty is not compatible with the literacy skills of a major part of the Brazilian population.

Como consentir sem entender? / How consent without knowing?

INTRODUÇÃO: Termo de Consentimento Livre e Esclarecido (TCLE) é o documento que informa sobre os benefícios e riscos de um estudo. Alguns autores concluíram que os TCLE são de difícil compreensão. OBJETIVO: Correlacionar grau de dificuldade dos TCLE, pelos índices de Flesch (IF) e Flesch-Kincaid (ILFK), utilizados num ambulatório de oncologia ao perfil de escolaridade dos usuários desse mesmo serviço, bem como verificar a legibilidade e a presença das informações obrigatórias segundo o item IV.1 da Resolução 196/96 do Conselho Nacional de Saúde. RESULTADOS: Foram obtidos 10 TCLE; segundo o IF e ILFK, a média foi de 38,5 e 18,16 respectivamente, mostrando ser necessário aproximadamente 18 anos de estudo para a compreensão, dado incompatível com a realidade de nossa população, em que mais de 50 por cento tem menos de oito anos de estudos. Em relação à qualidade dos termos, estes eram bem elaborados tecnicamente, contendo a maior parte dos itens necessários. Ao correlacionarmos o ILFK com a qualidade dos TCLEs, pôde-se observar que a qualidade dos termos não apresentou correlação com a legibilidade (p= 0.884, coeficiente de correlação de Pearson 0.053). CONCLUSÃO: O grau de dificuldade dos TCLE é incompatível com a escolaridade de nossa população e nossos TCLE apresentavam informações suficientes. Esperávamos relacionar a quantidade de informações ao grau de dificuldade de compreensão do texto, não sendo confirmada, mostrando a possibilidade de um TCLE ser completo ao mesmo tempo fácil de ler.

BACKGROUND: The Consent Form (CF) is an important document that informs patients about benefits and risks of a study, it assures patients the right to accept or reject participation in a procedure related to their health. Some authors believe that Consent Forms are complex and difficult to read for most people. OBJECTIVE: Correlate the difficulty of understanding CF, through the Flesch Index (FI) and Flesch-Kincaid Index (FKI), used in our oncology outpatient clinic, with the profile of our patient's education. We also wanted to verify readability and presence of the information which must be part of these CF according to item IV.1 from Resolution 196/96 of the Brazilian Health Council. RESULTS: We obtained 10 CFs, according to FI and FKI the mean was 38.5 and 18.16 respectively, indicating that, at least, 18 years of study are needed for the comprehension. This result is incompatible with the Brazilian population where more than 50 percent have less than 8 years of study. According to the quality of the CF, they were well elaborated, and had most of the necessary contents. When the authors correlated FKI and quality of CF, they concluded that the quality of CF does not correlate with readability (p= 0.884, Pearson correlation coefficients 0.053). CONCLUSION: Despite the good content quality of most of the analyzed CF, their level of reading difficulty is not compatible with the literacy skills of a major part of the Brazilian population.