Search results for "Randomized controlled"

Short- and Long-Term Quality of Life and Bowel Function in Patients With MRI-Defined, High-Risk, Locally Advanced Rectal Cancer Treated With an Inten…

2015

Objective Intensified preoperative treatments have been increasingly investigated in locally advanced rectal cancer (LARC), but limited data are available for the impact of these regimens on quality of life (QoL) and bowel function (BF). We assessed these outcome measures in EXPERT-C, a randomized phase 2 trial of neoadjuvant capecitabine combined with oxaliplatin (CAPOX), followed by chemoradiation therapy (CRT), total mesorectal excision, and adjuvant CAPOX with or without cetuximab in magnetic resonance imaging-defined, high-risk LARC. Methods and Materials QoL was assessed using the European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-CR29 questionnaires. Bowel inc…

Lifestyle, nutrition and breast cancer: facts and presumptions for consideration

2015

Breast cancer is the most common cancer in women worldwide, and the high incidence of this cancer coupled with improvements in initial treatments has led to an ever-increasing number of breast cancer survivors. Among the prospective epidemiological studies on diet and breast cancer incidence and recurrence, to date, there is no association that is strong, reproducible and statistically significant, with the exception of alcohol intake, overweight, and weight gain. Nevertheless, many beliefs about food and breast cancer persist in the absence of supporting scientific evidence. After a comprehensive review regarding the role of lifestyle on breast cancer outcomes and a thorough study of the d…

A randomized phase II study of estramustine phosphate versus estramustine phosphate plus etoposide in hormone refractory prostate cancer (HRPC)

2008

20632 Background: Docetaxel-based regimens represent the treatment of choice of HRPC. However, in some patients toxicity may be a concern and the quality of life may be compromised. The aim of this phase II randomized study is to investigate the efficacy and safety of low-dose chemotherapy regimen adopting a combination of EMP and VP16 in patients affected by HRPC. Methods: 54 HRPC patients were randomized between: arm A, daily oral standard dose EMP (10mg/kg) and arm B, low-dose EMP (3mg/kg) plus VP16 (25mg/mq) for 2 weeks followed by 2-weeks’rest. Systemic toxicity and hematologic exams were monitored every 2 weeks. Performance status, pain and analgesic use were evaluated according to WH…

Short fractionated radiotherapy versus multiple fractionated radiotherapy in patients with bone metastases: a meta-analysis of randomized clinical tr…

2003

The sarculator stratified prognosis of patients with high-risk soft tissue sarcomas (STS) of extremities and trunk wall treated with perioperative ch…

2017

11016 Background: Patients with extremity and trunk wall STS with high malignancy grade and size larger than 5cm are considered at high risk of death, but in fact this risk varies broadly depending on histologic subtype and size. The Sarculator, a nomogram for STS, can improve prognostic assessment of these patients. This tool was evaluated for stratifying risk of distant metastasis (DM) and overall survival (OS) in a RCT investigating perioperative chemotherapy. Methods: High-risk STS patients were randomly assigned to receive either three cycles of preoperative chemotherapy with epirubicin (120 mg/m2) and ifosfamide (9 g/m2) or the same three preoperative cycles followed by two further p…

Is guideline-adherent adjuvant treatment an equivalent option for elderly patients who cannot participate in adjuvant clinical breast cancer trials? …

2014

1063 Background: It is well accepted that innovation in oncology is transported through randomized clinical trials (CT). However, elderly patients (>65) are usually excluded from CT. Therefore this...

A Multicentric Randomized Trial to Evaluate the ROle of Uterine MANipulator on Laparoscopic/Robotic HYsterectomy for the Treatment of Early-Stage End…

2021

ObjectiveThis prospective randomized trial aimed to assess the impact of the uterine manipulator in terms of lymph vascular space invasion (LVSI) in patients undergoing minimally invasive staging for early-stage endometrial cancer.MethodsIn this multicentric randomized trial, enrolled patients were randomly allocated in two groups according to the no use (arm A) or the use (arm B) of the uterine manipulator. Inclusion criteria were G1-G2 early-stage endometrial cancer at preoperative evaluation. The variables collected included baseline demographic characteristics, perioperative data, final pathology report, adjuvant treatment, and follow-up.ResultsIn the study, 154 patients (76 in arm A an…

Nutraceuticals and Cardiovascular Disease

2021

Cardiovascular disease (CVD) remains the primary cause of mortality worldwide, taking an estimated 17.9 million lives each year. Among several cardiometabolic risk factors, dyslipidemia, and especially high low-density lipoprotein cholesterol (LDL-C) levels, are associated with the development and progression of atherosclerosis and its clinical sequelae. Recent studies have shown promising results for nutraceutical compounds on various CVD risk factors and complications. In addition to looking at individual nutrients or foods, dietary pattern have also emerged as a complementary approach to examine the relationship between the overall diet and the risk for CVD. The Mediterranean Diet (MedDi…

Bicycling to school improves the cardiometabolic risk factor profile:a randomised controlled trial

2012

Objectives To investigate whether bicycling to school improves cardiometabolic risk factor profile and cardiorespiratory fitness among children. Design Prospective, blinded, randomised controlled trial. Setting Single centre study in Odense, Denmark Participants 43 children previously not bicycling to school were randomly allocated to control group (n=20) (ie, no change in lifestyle) or intervention group (ie, bicycling to school) (n=23). Primary and secondary outcome measures Change in cardiometabolic risk factor score and change in cardiorespiratory fitness. Results All participants measured at baseline returned at follow-up. Based upon intention-to-treat (ITT) analyses, clustering of car…

Baseline adherence to the Mediterranean diet and major cardiovascular events: Prevención con dieta mediterránea trial

2014

Lifestyle modification, particularly dietary changes, is the cornerstone of population-based strategies for cardiovascular disease (CVD) prevention.1 Recently the Prevención con Dieta Mediterránea (PREDIMED) study,2 a 5-year randomized primary prevention trial (isrctn.org Identifier: ISRCTN35739639), showed a 30% reduction in incident CVD with Mediterranean diet (MeDiet) intervention in comparison with a control diet. At quarterly visits throughout the study, a validated 14-item MeDiet screening tool (Table 1) was used to assess conformity with this dietary pattern.3 Close monitoring of adherence to dietary instructions for CVD prevention is difficult in the clinical setting. Short dietary …