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
Medulloblastoma is the most common infratentorial malignant tumour under 15 years of age. In recent protocols, the patients are stratified for treatment in standard risk or high risk, according to the clinical variables as age, localized or disseminated disease, degree of surgical resection and more recently expected biological behaviour based on retrospective and prospective studies of former samples analyzed. The objectives for future treatments are reduce morbidity without jeopardizing survival.
Assuntos
Neoplasias Cerebelares/patologia , Neoplasias Cerebelares/terapia , Meduloblastoma/patologia , Meduloblastoma/terapia , Antineoplásicos/uso terapêutico , Criança , Ensaios Clínicos como Assunto , Terapia Combinada , Humanos , Procedimentos Neurocirúrgicos , RadioterapiaRESUMO
This study was designed to compare the antihypertensive efficacy of nitrendipine and atenolol in young and middle-aged patients with mild or moderate essential hypertension and to assess treatment effects on plasma lipids and potential changes in left ventricular mass (LVM). After 2 weeks off medication and a 4-week placebo phase, patients who met the inclusion criteria [sitting diastolic blood pressure (DBP) 95 to 114 mm Hg, age below 50 years] entered a 12-week dose-adjustment and maintenance period with nitrendipine or atenolol. Serum lipids were determined before and after therapy. At the same time, LVM was evaluated echocardiographically (M mode). Twenty-two patients completed the double-blind, randomized study. After 12 weeks on nitrendipine, the systolic blood pressure (SBP) and DBP were reduced (p less than 0.005 and p less than 0.001, respectively). No significant changes in heart rate were observed. There were no changes in the lipid profile, and LVM was reduced from 93.7 to 23.4 to 82.4 +/- 22.6 g/m2 of body surface (p less than 0.05). On atenolol the SBP and DBP were reduced (p less than 0.001 and p less than 0.001, respectively). The expected reduction in heart rate was significant (p less than 0.05). Total cholesterol and LDL cholesterol increased by 11% (p less than 0.05) and 12.3% (p less than 0.01), respectively. HDL cholesterol showed a small reduction. Tryglycerides increased by 22% (n.s.). LVM did not change. In conclusion, nitrendipine and atenolol showed comparable antihypertensive efficacy.(ABSTRACT TRUNCATED AT 250 WORDS)