RESUMO
PURPOSE: The objective of this trial was to evaluate the safety and efficacy of melatonin oral gel mouthwashes in the prevention and treatment of oral mucositis (OM) in patients treated with concurrent radiation and systemic treatment for head and neck cancer. METHODS: Randomized, phase II, double-blind, placebo-controlled trial (1:1 ratio) of 3% melatonin oral gel mouthwashes vs. placebo, during IMRT (total dose ≥ 66 Gy) plus concurrent Q3W cisplatin or cetuximab. Primary endpoint: grade 3-4 OM or Severe Oral Mucositis (SOM) incidence by RTOG, NCI, and a composite RTOG-NCI scales. Secondary endpoints: SOM duration and grade 2-4 OM or Ulcerative Oral Mucositis (UOM) incidence and duration. RESULTS: Eighty-four patients were included in the study. Concurrent systemic treatments were cisplatin (n = 54; 64%) or cetuximab (n = 30; 36%). Compared with the placebo arm, RTOG-defined SOM incidence was numerically lower in the 3% melatonin oral gel arm (53 vs. 64%, P = 0.36). In patients treated with cisplatin, assessed by the RTOG-NCI composite scale, both SOM incidence (44 vs. 78%; P = 0.02) and median SOM duration (0 vs. 22 days; P = 0.022) were significantly reduced in the melatonin arm. Median UOM duration assessed by the RTOG-NCI scale was also significantly shorter in the melatonin arm (49 vs. 73 days; P = 0.014). Rate of adverse events and overall response rate were similar between the two arms. CONCLUSIONS: Treatment with melatonin oral gel showed a consistent trend to lower incidence and shorter SOM duration and shorter duration of UOM. These results warrant further investigation in phase III clinical trial.
Assuntos
Antineoplásicos/efeitos adversos , Antioxidantes/administração & dosagem , Quimiorradioterapia/efeitos adversos , Melatonina/administração & dosagem , Antissépticos Bucais/administração & dosagem , Estomatite/prevenção & controle , Administração Oral , Adulto , Idoso , Idoso de 80 Anos ou mais , Antineoplásicos/administração & dosagem , Antioxidantes/efeitos adversos , Cetuximab/administração & dosagem , Cetuximab/efeitos adversos , Cisplatino/administração & dosagem , Cisplatino/efeitos adversos , Método Duplo-Cego , Feminino , Géis/administração & dosagem , Neoplasias de Cabeça e Pescoço , Humanos , Incidência , Masculino , Melatonina/efeitos adversos , Pessoa de Meia-Idade , Antissépticos Bucais/efeitos adversos , Placebos/administração & dosagem , Estudo de Prova de Conceito , Estudos Prospectivos , Estomatite/epidemiologia , Estomatite/etiologiaRESUMO
INTRODUCTION: Primary objective of the study was to assess the relative weighting between benefit in survival time (SV), benefit in quality of life (QoL) and willingness to experience adverse events (AEs), in patient preferences for chemotherapy treatment. MATERIALS AND METHODS: We included cancer patients with current or past systemic treatment of cancer (STC) as well as physicians placed as hypothetical patients. Participants filled a choice-based conjoint analysis questionnaire with 19 choices among three STC scenarios with variable amounts of benefit in SV or QoL and different types AEs. RESULTS: One hundred patients (50 on curative and 50 on palliative intention treatment) and 114 physicians (61 oncologists and 53 non-oncologists) were included and asked about their preferred chemotherapy treatment. The relative weighting (sum 100%) of SV-QoL-AEs for making the choice in the 100 patients was SV35%-CV33%-AEs31% what was not significantly different from a random distribution (Goodness of fit Chi square P = 0.91) just as it was not for both subgroups, palliative (SV37%-QoL29%-AEs34%; GoF Chi square P = 0.55) and curative (SV34%-QoL36%-AEs30%; GoF Chi square P = 0.73) treatment. The observed distribution in the group of 114 physicians (SV46%-QoL31%-AEs23%) was significantly different from a random distribution (GoF Chi square P = 0.018) just as it was for both subgroups, medical oncologists (SV48%-QoL29%-AEs23%; GoF Chi square P = 0.006) and non-medical oncologists (SV44%-QoL33%-AEs23%; GoF Chi square P = 0.04). CONCLUSIONS: The three attributes (SV, QoL, and AEs) are considered in the same way by cancer patients to make choices on their STC. On the contrary, when placed as hypothetical patients, physicians prefer for themselves those treatments that provide more SV.
Assuntos
Neoplasias/psicologia , Neoplasias/terapia , Qualidade de Vida/psicologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Atitude do Pessoal de Saúde , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/mortalidade , Neoplasias/patologia , Preferência do Paciente , Médicos , Inquéritos e Questionários , Taxa de SobrevidaRESUMO
OBJECTIVES Analysis of the results on the treatment of esophageal cancer by transthoracic esophagectomy by a multidisciplinary team of surgeons and oncologists. METHODS Between January 1990 and December 2009, 100 consecutive patients underwent transthoracic esophagectomy. Data were collected prospectively and clinical, pathological and histological features of the tumors were analyzed as well as the results of postoperative morbidity and mortality. RESULTS The average patient age was 55 years (range 31- 83 years). In 59 cases the tumor was located in the lower third and in 41 cases in the middle third. Forty-six patients had adenocarcinoma and 54 squamous cell carcinoma. In 54 cases radio-chemotherapy was planned preoperatively. Classifi cation according to pathological tumor stage was: stage 0 in 21 patients, stage I in 10 patients, stage IIa in 28, stage IIb in 9, stage III in 21 and stage IV in 11. The mean number of lymph nodes examined was 14 (range 0-28). Hospital mortality occurred in 4 cases and postoperative complications in 29 patients (33%). The most frequent postoperative complication was pulmonary complications in 17 cases. The average hospital stay was 15.2 days (range 10-40 days) CONCLUSIONS The results of esophageal cancer have been improved in recent years due to the formation of multidisciplinary teams in this pathology. In our study we have shown that the results obtained with the transthoracic technique for cancer of the esophagus are within the ranges reported in the literature for teams with high prevalence of the disease.
Assuntos
Adenocarcinoma/cirurgia , Carcinoma de Células Escamosas/cirurgia , Neoplasias Esofágicas/cirurgia , Esofagectomia , Excisão de Linfonodo , Adenocarcinoma/mortalidade , Adulto , Idoso , Idoso de 80 Anos ou mais , Carcinoma de Células Escamosas/mortalidade , Neoplasias Esofágicas/mortalidade , Feminino , Seguimentos , Mortalidade Hospitalar , Humanos , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Complicações Pós-Operatórias , Estudos Prospectivos , Taxa de Sobrevida , Resultado do TratamentoRESUMO
BACKGROUND: It was already evidenced decreased heart rate variability (HRV) in chronic obstructive pulmonary disease (COPD) patients at rest. OBJECTIVE: In order to insert new elements in the literature regarding this issue, we evaluated geometric index of HRV in COPD subjects. METHOD: We analyzed data from 34 volunteers, divided into two groups according to spirometric values: COPD (17 volunteers, FEV1/FVC=47.3±10.2; FEV1=50.8±15.7) and control (17 volunteers, FEV1/FVC=78.8±10.8; FEV1=100.1±14.7). For analysis of HRV indexes the volunteers remained in the supine position for 30 minutes. We analyzed the following indexes: triangular index (RRtri), triangular interpolation of RR intervals (TINN) and Poincaré plot (SD1, SD2 and SD1/SD2). Student t test for unpaired samples and Mann-Whitney test were used for data analysis. RESULTS: We observed statistically significant reductions in geometric indexes in the COPD group: RRtri (0.043±0.01 vs. 0.059±0.02; p=0.018), TINN (105.88±51.82 vs. 151.47±49.9; p=0.014), SD1 (9.76±4.66 vs. 14.55±6.04; p=0.014) and SD2 (34.86±17.02 vs. 51.51±18.38; p=0.010). SD1/SD2 (0.30±0.11 vs. 0.28±0.07; p=0.605) were not significantly different between groups. Patients with COPD presented a visual analysis of Poincaré plot of lower dispersion of RR intervals both beat to beat and the long term. CONCLUSION: Subjects with COPD present reduction of geometric indexes of HRV, indicating reduced heart rate variability.
Assuntos
Frequência Cardíaca/fisiologia , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Idoso , Feminino , Testes de Função Cardíaca/métodos , Humanos , MasculinoRESUMO
In this study the baroreflex sensitivity of conscious, juvenile, spontaneously hypertensive rats (SHRs) was compared. The study population consisted of 19 eight-week-old male SHRs. The baroreflex sensitivity was quantified as the derivative of the variation in heart rate (HR) and the variation of mean arterial pressure (baroreflex sensitivity = ΔHR/ΔMAP). MAP was manipulated with sodium nitroprusside (SNP) and phenylephrine (PHE), administered via an inserted cannula in the right femoral vein. The SHRs were divided into four groups: (1) low bradycardic baroreflex (LB) where the baroreflex gain (BG) was between 0 and -1 bpm/mmHg with PHE; (2) high bradycardic baroreflex (HB), where the BG was < -1 bpm/mmHg with PHE; (3) low tachycardic baroreflex (LT) where the BG was between 0 and 3 bpm/mmHg with SNP; (4) high tachycardic baroreflex (HT) where the BG was > 3 bpm/mmHg with SNP. We noted that 36.8% of the rats presented with an increased bradycardic reflex, while 27.8% demonstrated an attenuated tachycardic reflex. No significant alterations were noted regarding the basal MAP and HR. There were significant differences in the baroreflex sensitivity between SHRs in the same laboratory. One should be careful when interpreting studies employing the SHR as a research model.
Assuntos
Barorreflexo , Pressão Sanguínea , Frequência Cardíaca , Hipertensão/fisiopatologia , Fatores Etários , Animais , Barorreflexo/efeitos dos fármacos , Pressão Sanguínea/efeitos dos fármacos , Bradicardia/fisiopatologia , Modelos Animais de Doenças , Frequência Cardíaca/efeitos dos fármacos , Masculino , Ratos , Ratos Endogâmicos SHR , Ratos Endogâmicos WKY , Taquicardia/fisiopatologia , Vasoconstritores/farmacologia , Vasodilatadores/farmacologiaRESUMO
Bronchoesophageal fistula secondary to lymphoma is a very rare condition, usually associated with chemo-radiotherapy. We report a case of a patient with a non-Hodgkin's lymphoma (NHL) who, after chemotherapy, developed an oesophago-tracheal fistula. Initially it was treated conservatively but due to the lack of response, a stent was inserted. After nearly one year without success, surgery was considered. Right thoracotomy oesophagectomy and closure of the tracheal defect with an intercostal muscle flap and pericardial patch was performed. This was followed by laparoscopic creation of a gastric tube, which was successfully anastomosed to the cervical oesophagus through a cervicotomy. Unlike oesophageal cancer, NHL can have a good prognosis, so curative treatment of the fistula can be considered. Conservative treatment must always be the first option, leaving stenting or surgery for when the problem persists.
Assuntos
Fístula Brônquica/etiologia , Fístula Brônquica/cirurgia , Linfoma não Hodgkin/complicações , Fístula Traqueoesofágica/etiologia , Fístula Traqueoesofágica/cirurgia , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Humanos , Linfoma não Hodgkin/tratamento farmacológico , MasculinoRESUMO
It was evaluated movements of lower limb in the double pulley system equipment on ten male volunteers during contraction of gastrocnemius (caput laterale) and gluteus maximus muscles in the following movements: 1) hip extension with extended knee and erect trunk, 2) hip extension with flexed knee and erect trunk, 3) hip extension with flexed knee and erect trunk, 3) hip extension with extended knee and inclined trunk, 5) hip abduction along the midline, 7) hip abduction with extension beyond the midline, 8) adduction with hip flexion beyond the midline, 8) adduction with hip flexion beyond the midline, and 9) adduction with hip extension beyond the midline. Myoelectric signals were taken up by Lec Tec surface electrodes connected to a 6-channel Lynx electromyographic signal amplifier coupled with a computer equipped with a model CAD 10/26 analogue digital conversion board and with a specific software for signal recording and analysis. We observed weak gastrocnemius muscle activity for all movements studied. In the case of gluteus maximus, the most important potentials were observed for movement 2, while for the remaining movements the actions were of reasonable intensity. Compared to gluteus, gastrocnemius was less required for all movements.