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Randomized controlled trial cancer

Dong-Liang Chen, Yu-Hong Li, Zhi-Juan Wang, Ye-Ke Zhu
Gabapentin has been used as an adjuvant for treatment of cancer pain. Previous studies showed that opioids combined with gabapentin for management of cancer pain reduced the dosage of opioids.The objective of this study was to explore the clinical effect and patients' satisfaction of oxycontin combined with gabapentin in treatment of severe cancer pain. After titration of morphine, 60 severe cancer patients with visual analog score (VAS) more than 7 were randomly divided into trial group (n = 30) and control group (n = 30)...
October 2016: Medicine (Baltimore)
Olivier Mir, Thomas Brodowicz, Antoine Italiano, Jennifer Wallet, Jean-Yves Blay, François Bertucci, Christine Chevreau, Sophie Piperno-Neumann, Emmanuelle Bompas, Sébastien Salas, Christophe Perrin, Corinne Delcambre, Bernadette Liegl-Atzwanger, Maud Toulmonde, Sarah Dumont, Isabelle Ray-Coquard, Stéphanie Clisant, Sophie Taieb, Cécile Guillemet, Maria Rios, Olivier Collard, Laurence Bozec, Didier Cupissol, Esma Saada-Bouzid, Christine Lemaignan, Wolfgang Eisterer, Nicolas Isambert, Loïc Chaigneau, Axel Le Cesne, Nicolas Penel
BACKGROUND: Regorafenib is a multikinase inhibitor with proven activity in refractory gastrointestinal stromal tumours and chemotherapy-refractory advanced colorectal cancers. We assessed this agent's efficacy and safety in patients with metastatic soft tissue sarcomas previously treated with anthracycline. METHODS: In this randomised, double-blind, phase 2 trial undertaken in France and Austria, we enrolled patients aged 18 years and older with advanced soft tissue sarcomas who had received previous doxorubicin or other anthracycline treatment...
October 14, 2016: Lancet Oncology
Stella Capriglione, Francesco Plotti, Roberto Montera, Daniela Luvero, Salvatore Lopez, Giuseppe Scaletta, Alessia Aloisi, Giovan Battista Serra, Roberto Angioli
OBJECTIVES: To examine the effects of paroxetine supplementation on hot flashes and sleep in gynecological cancer survivors. METHODS: In a randomized, double-blind, placebo-controlled study, postmenopausal women with a prior history of stage 0-III gynecological cancer who had completed active cancer treatment (including hormonal therapy) were randomly assigned 1:1 to either 7.5mg oral paroxetine or placebo daily for 16weeks. Sleep and hot flashes were assessed at baseline, week 4 and week 16...
October 14, 2016: Gynecologic Oncology
Rowan T Chlebowski, Wendy Barrington, Aaron K Aragaki, JoAnn E Manson, Gloria Sarto, Mary J OʼSullivan, Daniel Wu, Jane A Cauley, Lihong Qi, Robert L Wallace, Ross L Prentice
OBJECTIVE: In postmenopausal black women in the Women's Health Initiative randomized trial, estrogen alone reduced breast cancers but its comprehensive influence on health outcomes in black women is unknown. Therefore, we examined this issue in the Women's Health Initiative overall and by African ancestry. METHODS: A total of 1,616 black women with prior hysterectomy, including 1,061 with percent African ancestry determination, at 40 US centers were randomly assigned to conjugated equine estrogen (0...
October 3, 2016: Menopause: the Journal of the North American Menopause Society
Denghai Mi, Weiwei Ren, Kehu Yang
BACKGROUND & OBJECTIVES: The effectiveness of interleukin-2 (IL-2) and induced killer cells for non-small cell lung cancer (NSCLC) is controversial. This study evaluates the efficacy and safety of interleukin-2 and induced killer cells on NSCLC, so as to provide references for further clinical practice and research. METHODS: Relevant randomized controlled trials (RCTs) were searched in Cochrane library (Issue 2, 2013), Web of Science (1980-March 2013), PubMed (1966-March 2013), China Knowledge Resource Integrated database (CNKI) (1994-March 2013), China Biology Medicine database (CBM) (1978-March 2013), VIP (1989-March 2013), and Wan Fang databases (1997-March 2013)...
May 2016: Indian Journal of Medical Research
Yuqin Huang, Sen Wang, Dong Tang, Youquan Shi, Wei Wang, Yang Chong, Huaicheng Zhou, Qingquan Xiong, Jie Wang, Daorong Wang
Uncut Roux-en-Y gastrojejunostomy is a modification of the Billroth II procedure with Braun anastomosis, in which a jejunal occlusion is fashioned to avoid the Roux Stasis Syndrome. This review aimed to summarize the current knowledge about the uncut Roux-en-Y anastomosis operation, so that surgeons may be able to make informed decisions about its clinical application. Additionally, we hope that our findings will guide future research on this topic. Areas covered: The original uncut technique was associated with dehiscence or recanalization of the jejunal occlusion, and was therefore not widely applied...
October 17, 2016: Expert Review of Gastroenterology & Hepatology
Aris Koryllos, Astrid Althaus, Marcel Poels, Robin Joppich, Rolf Lefering, Frank Wappler, Wolfram Windisch, Corinna Ludwig, Erich Stoelben
BACKGROUND: Thoracotomy leads to chronic neuropathic pain in up to 50% of patients and is responsible for an impaired quality of life. Intercostal nerve injury has been suggested to be responsible for this pain. In the present study the impact of paravertebral intercostal neurectomy on post thoracotomy pain was assessed. METHODS: In this single center parallel-group randomized controlled trial patients underwent muscle sparing anterolateral thoracotomy and anatomical lung resection for lung cancer...
September 2016: Journal of Thoracic Disease
Mahesh Kudrimoti, Amarintha Curtis, Samar Azawi, Francis Worden, Sanford Katz, Douglas Adkins, Marcelo Bonomi, Jenna Elder, Stephen T Sonis, Richard Straube, Oreola Donini
Dusquetide, a novel Innate Defense Regulator, modulates the innate immune system at a key convergence point in intracellular signaling pathways and has demonstrated activity in both reducing inflammation and increasing clearance of bacterial infection. Innate immunity has also been implicated in the pathogenesis of oral mucositis (OM), a universal toxicity of chemoradiation therapy (CRT). Testing the hypothesis that dusquetide can mitigate the development and duration of OM, preclinical studies have been completed and correlated with interim results from a Phase 2 clinical study in patients undergoing CRT for head and neck cancer...
October 13, 2016: Journal of Biotechnology
Yun-Chen Li, Lin Zhao, Jiang-Ping Wu, Chen-Xu Qu, Qing-Kun Song, Rui-Bin Wang
BACKGROUND AIMS: To investigate the clinical benefits of cytokine-induced killer (CIK) cell infusions on hepatocellular carcinoma (HCC) patients, combined with other conventional treatments. METHODS: This was a systematic review and meta-analysis conducted among phase II and III randomized control trials worldwide. Review manager 5.2 version was used to pool the effect size across studies. Sensitivity analyses and risk of bias were estimated among included studies...
October 13, 2016: Cytotherapy
M B Rehman, B V Tudrej, J Soustre, M Buisson, P Archambault, D Pouchain, H Vaillant-Roussel, F Gueyffier, J-L Faillie, M-C Perault-Pochat, C Cornu, R Boussageon
BACKGROUND: Guidelines for type 2 diabetes (T2D) recommend reducing HbA1c through lifestyle interventions and glucose-lowering drugs (metformin, then combination with dipeptidyl peptidase-4 inhibitors [DPP-4Is] among other glucose-lowering drugs). However, no double-blind randomized clinical trial (RCT) compared with placebo has so far demonstrated that DDP-4Is reduce micro- and macrovascular complications in T2D. Moreover, the safety of DPP-4Is (with increased heart failure and acute pancreatitis) remains controversial...
October 10, 2016: Diabetes & Metabolism
Markus K Schuler, Leopold Hentschel, Wadim Kisel, Michael Kramer, Felicitas Lenz, Beate Hornemann, Julia Hoffmann, Stephan Richter, Gerhard Ehninger, Martin Bornhäuser, Frank Kroschinsky
CONTEXT: Physical exercise can alleviate cancer related fatigue. Randomized controlled trials (RCT) in patients with advanced cancer are scarce. OBJECTIVES: We test the impact of a structured, individual sports program on fatigue in patients with advanced cancer. METHODS: 77 patients were invited to participate in this RCT exploring the effects of physical exercises on fatigue 12 and 24 weeks after baseline. Patients were randomized into three groups...
October 12, 2016: Journal of Pain and Symptom Management
Rajesh Patel, Michael J Sweeting, Janet T Powell, Roger M Greenhalgh
BACKGROUND: Short-term survival benefits of endovascular aneurysm repair (EVAR) versus open repair of intact abdominal aortic aneurysms have been shown in randomised trials, but this early survival benefit is lost after a few years. We investigated whether EVAR had a long-term survival benefit compared with open repair. METHODS: We used data from the EVAR randomised controlled trial (EVAR trial 1), which enrolled 1252 patients from 37 centres in the UK between Sept 1, 1999, and Aug 31, 2004...
October 12, 2016: Lancet
Tian-Tian Wu, Wei-Min Li, Hu-Cheng Li, Guo-Kun Ao, Fang Zheng, Hu Lin
PURPOSE: The clinical efficacy of intraductal radiofrequency ablation (RFA) with Habib™ EndoHPB catheter, a newly developed intervention for malignant extrahepatic biliary obstruction, remains uncertain. The aim of this study was to investigate the clinical efficacy of intraductal RFA. METHODS: Data from 71 patients with extrahepatic distal cholangiocarcinoma were retrospectively analyzed. The study patients were divided into RFA and control groups. The RFA group had undergone percutaneous transhepatic intraductal RFA with a Habib™ EndoHPB catheter, followed by placement of covered or uncovered biliary self-expandable metallic stents (SEMs) whereas the control group had undergone percutaneous transhepatic covered or uncovered SEMs placement...
October 14, 2016: Cardiovascular and Interventional Radiology
Eden C Payabyab, Sanjeeve Balasubramaniam, Maureen Edgerly, Margarita Velarde, Maria J Merino, Aradhana M Venkatesan, Harshraj Leuva, Thomas Litman, Susan E Bates, Tito Fojo
The development of new therapies has lagged behind for rare cancers without defined therapeutic targets. Adrenocortical cancer is no exception. Mitotane, an older agent considered "adrenolytic," is used both to control symptoms in advanced disease and as adjuvant therapy after surgical resection. Molecular characterization of adrenocortical cancer has deepened our understanding of this genetically complex disease while identifying subgroups whose importance remains to be determined. Unfortunately, such studies have yet to demonstrate a therapeutic target for drug development, and to date, no targeted therapy has achieved meaningful outcomes...
October 15, 2016: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
Xiaozhou Fan, Alexander V Alekseyenko, Jing Wu, Brandilyn A Peters, Eric J Jacobs, Susan M Gapstur, Mark P Purdue, Christian C Abnet, Rachael Stolzenberg-Solomon, George Miller, Jacques Ravel, Richard B Hayes, Jiyoung Ahn
OBJECTIVE: A history of periodontal disease and the presence of circulating antibodies to selected oral pathogens have been associated with increased risk of pancreatic cancer; however, direct relationships of oral microbes with pancreatic cancer have not been evaluated in prospective studies. We examine the relationship of oral microbiota with subsequent risk of pancreatic cancer in a large nested case-control study. DESIGN: We selected 361 incident adenocarcinoma of pancreas and 371 matched controls from two prospective cohort studies, the American Cancer Society Cancer Prevention Study II and the National Cancer Institute Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial...
October 14, 2016: Gut
J C Del Paggio, B Azariah, R Sullivan, W M Hopman, F V James, S Roshni, I F Tannock, C M Booth
BACKGROUND: The European Society for Medical Oncology (ESMO) recently released a magnitude of clinical benefit scale (ESMO-MCBS) for systemic therapies for solid cancers. Here, we evaluate contemporary randomized controlled trials (RCTs) against the proposed ESMO thresholds for meaningful clinical benefit. METHODS: RCTs evaluating systemic therapy for breast cancer, non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic cancer published 2011-2015 were reviewed...
October 13, 2016: Annals of Oncology: Official Journal of the European Society for Medical Oncology
Ernesto Zecca, Cinzia Brunelli, Paola Bracchi, Giuseppe Biancofiore, Carlo De Sangro, Roberto Bortolussi, Luigi Montanari, Marco Maltoni, Cecilia Moro, Ugo Colonna, Gabriele Finco, Maria Teresa Roy, Vittorio Ferrari, Oscar Alabiso, Giovanni Rosti, Stein Kaasa, Augusto Caraceni
: Context Oxycodone and morphine are recommended as first-choice opioids for moderate/severe cancer pain but evidence about their relative tolerability has significant methodological limitations. OBJECTIVES: This study is mainly aimed at comparing the risk of developing adverse events (AEs) with controlled release oral morphine versus oxycodone; secondary aims were comparing their analgesic efficacy and testing heterogeneity in tolerability across different age and renal function subgroups...
October 11, 2016: Journal of Pain and Symptom Management
Ze-Chun Zhang, Qi-Ni Xu, Sui-Ling Lin, Xu-Yuan Li
Capecitabine has been investigated in early breast cancer in several studies, but it was undefined that whether it could improve survival. To investigate whether the addition of capecitabine affected survival in patients with early breast cancer, a meta-analysis was conducted and overall survival (OS), disease-free survival (DFS), and toxicity were assessed. The PubMed, Embase databases and the Cochrane Central Register of Controlled Trials were searched for studies between January 2006 and April 2016. Hazard ratios (HRs) with their 95% confidence intervals (CIs), or data for calculating HRs with 95% CI were derived...
2016: PloS One
James V Fiorica
This article is an overview of the modalities available for breast cancer screening. The modalities discussed include digital mammography, digital breast tomosynthesis, breast ultrasonography, magnetic resonance imaging, and clinical breast examination. There is a review of pertinent randomized controlled trials, studies and meta-analyses which contributed to the evolution of screening guidelines. Ultimately, 5 major medical organizations formulated the current screening guidelines in the United States. The lack of consensus in these guidelines represents an ongoing controversy about the optimal timing and method for breast cancer screening in women...
October 12, 2016: Clinical Obstetrics and Gynecology
Joseph C Dort, D Gregory Farwell, Merran Findlay, Gerhard F Huber, Paul Kerr, Melissa A Shea-Budgell, Christian Simon, Jeffrey Uppington, David Zygun, Olle Ljungqvist, Jeffrey Harris
Importance: Head and neck cancers often require complex, labor-intensive surgeries, especially when free flap reconstruction is required. Enhanced recovery is important in this patient population but evidence-based protocols on perioperative care for this population are lacking. Objective: To provide a consensus-based protocol for optimal perioperative care of patients undergoing head and neck cancer surgery with free flap reconstruction. Evidence Review: Following endorsement by the Enhanced Recovery After Surgery (ERAS) Society to develop this protocol, a systematic review was conducted for each topic...
October 13, 2016: JAMA Otolaryngology—Head & Neck Surgery
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