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randomized controlled trial toxicity

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https://www.readbyqxmd.com/read/27913933/fatigue-reduction-diet-in-breast-cancer-survivors-a-pilot-randomized-clinical-trial
#1
Suzanna Maria Zick, Justin Colacino, Maria Cornellier, Tohfa Khabir, Katie Surnow, Zora Djuric
PURPOSE: Fatigue is a prevalent and burdensome effect of breast cancer. Fatigue has been linked to chronic inflammation, and diets high in antioxidant nutrients have been associated with lesser prevalence and severity of fatigue. Studies are needed, however, to test if antioxidant-rich diets could improve fatigue. METHODS: Pilot, randomized, trial conducted between January 2014 and April 2015, to investigate if a 3-month diet rich in fruit, vegetables, whole grains, and omega-3 fatty acid-rich foods, named the fatigue reduction diet (FRD), improved fatigue and sleep compared to an attention control, named the general health curriculum (GHC)...
December 2, 2016: Breast Cancer Research and Treatment
https://www.readbyqxmd.com/read/27912953/evaluating-the-effect-of-matricaria-recutita-and-mentha-piperita-herbal-mouthwash-on-management-of-oral-mucositis-in-patients-undergoing-hematopoietic-stem-cell-transplantation-a-randomized-double-blind-placebo-controlled-clinical-trial
#2
Maria Tavakoli Ardakani, Sara Ghassemi, Mahshid Mehdizadeh, Faraz Mojab, Jamshid Salamzadeh, Samaneh Ghassemi, Abbas Hajifathali
OBJECTIVES: To investigate the effects of Matricaria recutita and Mentha piperita on oral mucositis (OM) in patients undergoing hematopoietic stem cell transplantation (HSCT). DESIGN: Randomized double blind placebo controlled clinical trial. SETTING: Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, and Bone Marrow Transplantation Center at Taleghani Teaching Hospital, Tehran, Iran. PARTICIPANTS: Sixty patients undergoing HSCT were randomly assigned to two groups: placebo (n=33), and herbal mouthwash group (n=27)...
December 2016: Complementary Therapies in Medicine
https://www.readbyqxmd.com/read/27906027/antiretroviral-treatment-regardless-of-cd4-count-the-universal-answer-to-a-contextual-question
#3
REVIEW
Serge P Eholié, Anani Badje, Gérard M Kouame, Jean-Baptiste N'takpe, Raoul Moh, Christine Danel, Xavier Anglaret
After a period where it was recommended to start antiretroviral therapy (ART) early, the CD4 threshold for treating asymptomatic adults dropped to 200/mm(3) at the beginning of the 2000s. This was mostly due to a great prudence with regards to drug toxicity. The ART-start CD4 threshold in most international guidelines was then raised to 350/mm(3) in 2006-2009 and to 500/mm(3) in 2009-2013. Between 2012 and 2015, international guidelines went the last step further and recommended treating all HIV-infected adults regardless of their CD4 count...
July 26, 2016: AIDS Research and Therapy
https://www.readbyqxmd.com/read/27901493/has-aidi-injection-the-attenuation-and-synergistic-efficacy-to-gemcitabine-and-cisplatin-in-non-small-cell-lung-cancer-a-meta-analysis-of-36-randomized-controlled-trials
#4
Zheng Xiao, Chengqiong Wang, Ling Chen, Xuemei Tang, Lianhong Li, Nana Li, Jing Li, Qihai Gong, Fushan Tang, Jihong Feng, Xiaofei Li
Gemcitabine and cisplatin is the first line chemotherapy for non-small cell lung cancer with high toxicity. Aidi injection is a cantharidin and astragalu-based Chinese herbs injection in China. Has Aidi injection attenuation and synergistic efficacy to GP in NSCLC? There is lack of strong evidence to prove it. To further reveal it, we systematically evaluated all related studies. We collected all studies about Aidi injection plus GP for NSCLC in Medline, Embase, Web of Science, CNKI, VIP, Wanfang Database, CBM, CCRCT, Chi-CTR, and US-clinical trials (established to June 2015)...
November 25, 2016: Oncotarget
https://www.readbyqxmd.com/read/27896440/a-phase-iii-open-label-randomized-multicenter-controlled-trial-of-oral-versus-intravenous-treosulfan-in-heavily-pretreated-recurrent-ovarian-cancer-a-study-of-the-north-eastern-german-society-of-gynecological-oncology-noggo
#5
Jalid Sehouli, Oliver Tomè, Desislava Dimitrova, Oumar Camara, Ingo Bernhard Runnebaum, Hans Werner Tessen, Beate Rautenberg, Radoslav Chekerov, Mustafa Zelal Muallem, Michael Patrick Lux, Tanja Trarbach, Gerald Gitsch
OBJECTIVE: In recurrent ovarian cancer (ROC), there is a high demand on effective therapies with a mild toxicity profile. Treosulfan is an alkylating agent approved as oral (p.o.) and intravenous (i.v.) formulation for the treatment of recurrent ovarian cancer. Data on safety and efficacy for either formulation are rare. For the first time we conducted a randomized phase III study comparing both formulations in women with ROC. METHODS: Patients having received at least two previous lines of chemotherapy were randomly assigned to one of two treatment arms: treosulfan i...
November 28, 2016: Journal of Cancer Research and Clinical Oncology
https://www.readbyqxmd.com/read/27896243/profile-of-tivantinib-and-its-potential-in-the-treatment-of-hepatocellular-carcinoma-the-evidence-to-date
#6
REVIEW
Daniel Pievsky, Nikolaos Pyrsopoulos
Hepatocellular carcinoma (HCC) is the fastest rising cause of cancer-related death in the United States and carries a very poor prognosis, with a median survival time of <50% at 1 year for advanced disease. To date, sorafenib is the only therapy approved by the Food and Drug Administration for the treatment of advanced HCC. Tivantinib (ARQ-197), a non-ATP competitive inhibitor of cellular mesenchymal-epithelial transcription factor (c-MET), has shown a survival benefit in patients with advanced HCC who have failed or are intolerant to sorafenib in Phase I and II trials...
2016: Journal of Hepatocellular Carcinoma
https://www.readbyqxmd.com/read/27893423/efficacy-and-safety-of-icotinib-in-treating-non-small-cell-lung-cancer-a-systematic-evaluation-and-meta-analysis-based-on-15-studies
#7
Rong Biaoxue, Liu Hua, Gao Wenlong, Yang Shuanying
Icotinib is a new epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that developed and used in China; this work was to evaluate its efficacy and safety in treating non-small cell lung cancer (NSCLC). Clinical studies evaluating the efficacy and safety of icotinib in treating NSCLC were identified from the databases of Medline, Web of Science, Embase and Cochrance Library. Pooled efficacy and safety of icotinib were calculated through a series of predefined search strategies. A total of 15 studies with 2,304 patients were involved in this study...
November 22, 2016: Oncotarget
https://www.readbyqxmd.com/read/27893331/multidisciplinary-approach-to-novel-therapies-in-cardio-oncology-research-manticore-101-breast-a-randomized-trial-for-the-prevention-of-trastuzumab-associated-cardiotoxicity
#8
Edith Pituskin, John R Mackey, Sheri Koshman, Davinder Jassal, Marshall Pitz, Mark J Haykowsky, Joseph J Pagano, Kelvin Chow, Richard B Thompson, Larissa J Vos, Sunita Ghosh, Gavin Y Oudit, Justin A Ezekowitz, D Ian Paterson
Purpose The primary toxicity of trastuzumab therapy for human epidermal growth factor receptor 2-overexpressing (HER2-positive) breast cancer is dose-independent cardiac dysfunction. Angiotensin-converting enzyme inhibitors and β-blockers are recommended first-line agents for heart failure. We hypothesized that angiotensin-converting enzyme inhibitors and β-blockers could prevent trastuzumab-related cardiotoxicity. Patients and Methods In this double-blinded, placebo-controlled trial, patients with HER2-positive early breast cancer were randomly assigned to receive treatment with perindopril, bisoprolol, or placebo (1:1:1) for the duration of trastuzumab adjuvant therapy...
November 28, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/27891443/a-randomized-prospective-study-of-concurrent-chemo-radiotherapy-vs-accelerated-hyperfractionation-in-advanced-cancer-of-head-and-neck
#9
Himanshu Mishra, Ritusha Mishra, Uday Prataap Shahi, Abhijit Mandal
INTRODUCTION: Locally advanced unresectable squamous cell carcinoma of head and neck has poor locoregional control when treated with conventionally fractionated Radiation Therapy (RT) alone. However, Concurrent Chemo-Radiotherapy (CRT) and altered fractionated RT schedules like Accelerated Hyperfractionation (AHF) are two different treatment strategies that have shown to be associated with better efficacy as compared to conventional RT alone in such cases. AIM: Aim of the study was to compare these two treatment strategies i...
October 2016: Journal of Clinical and Diagnostic Research: JCDR
https://www.readbyqxmd.com/read/27882700/effects-of-lapatinib-or-trastuzumab-alone-and-in-combination-in-human-epidermal-growth-factor-receptor-2-positive-breast-cancer-a-meta-analysis-of-randomized-controlled-trials
#10
Yong Xin, Wen Wen Guo, Qian Huang, Pei Zhang, Long-Zhen Zhang, Guan Jiang, Ye Tian
This meta-analysis compared the efficiency and safety of lapatinib and trastuzumab, alone or in combination, administered with neoadjuvant chemotherapy in patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer. For dichotomous variables, the relative risk ratio (RR) and 95% confidence interval (CI) were used to investigate outcome measures: pathological complete response (pCR), neutropenia, diarrhea, dermatologic toxicity, and congestive heart failure (CHF). Eight randomized controlled trials of 2350 participants (837 receiving lapatinib, 913 trastuzumab, and 555 combination therapy) were selected to compare the efficiency and safety of lapatinib to trastuzumab...
November 23, 2016: Cancer Medicine
https://www.readbyqxmd.com/read/27876603/canadian-phase-iii-randomized-trial-of-stereotactic-body-radiotherapy-versus-conventionally-hypofractionated-radiotherapy-for-stage-i-medically-inoperable-non-small-cell-lung-cancer-rationale-and-protocol-design-for-the-ontario-clinical-oncology-group-ocog
#11
Anand Swaminath, Marcin Wierzbicki, Sameer Parpia, James R Wright, Theodoros K Tsakiridis, Gordon S Okawara, Vijayananda Kundapur, Alexis Bujold, Naseer Ahmed, Khalid Hirmiz, Elizabeth Kurien, Edith Filion, Zsolt Gabos, Sergio Faria, Alexander V Louie, Timothy Owen, Elaine Wai, Kevin Ramchandar, Elisa K Chan, Jim Julian, Kathryn Cline, Timothy J Whelan
We describe a Canadian phase III randomized controlled trial of stereotactic body radiotherapy (SBRT) versus conventionally hypofractionated radiotherapy (CRT) for the treatment of stage I medically inoperable non-small-cell lung cancer (OCOG-LUSTRE Trial). Eligible patients are randomized in a 2:1 fashion to either SBRT (48 Gy in 4 fractions for peripherally located lesions; 60 Gy in 8 fractions for centrally located lesions) or CRT (60 Gy in 15 fractions). The primary outcome of the study is 3-year local control, which we hypothesize will improve from 75% with CRT to 87...
October 3, 2016: Clinical Lung Cancer
https://www.readbyqxmd.com/read/27873308/adjuvant-platinum-based-chemotherapy-for-early-stage-cervical-cancer
#12
REVIEW
Frederico S Falcetta, Lídia Rf Medeiros, Maria I Edelweiss, Paula R Pohlmann, Airton T Stein, Daniela D Rosa
BACKGROUND: This is the second updated version of the original Cochrane review published in the Cochrane Library 2009, Issue 3. Most women with early cervical cancer (stages I to IIA) are cured with surgery or radiotherapy, or both. We performed this review originally because it was unclear whether cisplatin-based chemotherapy after surgery, radiotherapy or both, in women with early stage disease with risk factors for recurrence, was associated with additional survival benefits or risks...
November 22, 2016: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/27871587/peripheral-nerve-blocks-in-the-management-of-postoperative-pain-challenges-and-opportunities
#13
REVIEW
Girish Joshi, Kishor Gandhi, Nishant Shah, Jeff Gadsden, Shelby L Corman
Peripheral nerve blocks (PNBs) are increasingly used as a component of multimodal analgesia and may be administered as a single injection (sPNB) or continuous infusion via a perineural catheter (cPNB). We undertook a qualitative review focusing on sPNB and cPNB with regard to benefits, risks, and opportunities for optimizing patient care. Meta-analyses of randomized controlled trials have shown superior pain control and reductions in opioid consumption in patients receiving PNB compared with those receiving intravenous opioids in a variety of upper and lower extremity surgical procedures...
December 2016: Journal of Clinical Anesthesia
https://www.readbyqxmd.com/read/27868411/-efficacy-of-neoadjuvant-chemotherapy-combined-with-bevacizumab-versus-neoadjuvant-chemotherapy-alone-for-her2-negative-breast-cancer-a-meta-analysis-of-randomized-controlled-clinical-trials
#14
Rui Han, Guanying Wang, Yujiao Zhang, Xinhan Zhao
Objective: To evaluate the efficacy and safety of neoadjuvant chemotherapy combined with bevacizumab versus neoadjuvant chemotherapy alone for Her2-negative breast cancer.Methods: We searched PubMed, the Cochrane Library, Web of Science, CNKI, Wanfang Database and the abstracts of major international conferences in recent 5 years to identify prospective randomized controlled clinical trials that met the inclusion and exclusion criteria. Study selection and analyses were undertaken according to the Cochrane Handbook...
May 25, 2016: Zhejiang da Xue Xue Bao. Yi Xue Ban, Journal of Zhejiang University. Medical Sciences
https://www.readbyqxmd.com/read/27868295/efficacy-and-safety-of-cisplatin-based-versus-nedaplatin-based-regimens-for-the-treatment-of-metastatic-recurrent-and-advanced-esophageal-squamous-cell-carcinoma-a-systematic-review-and-meta-analysis
#15
Fei Zhang, Yun Wang, Zhi-Qiang Wang, Peng Sun, De-Shen Wang, Yuan-Xue Jiang, Dong-Sheng Zhang, Feng-Hua Wang, Rui-Hua Xu, Yu-Hong Li
Cisplatin and nedaplatin show significant antitumor activity and have been widely used for esophageal squamous cell carcinoma (ESCC). However, it is still unclear whether the efficacy and safety of nedaplatin-based regimens are comparable to those of cisplatin-based regimens in patients with metastatic/recurrent or advanced ESCC. Therefore, we conducted a systematic review and meta-analysis to compare the efficacy and safety of these two regimens for the treatment of metastatic/recurrent and advanced ESCC. We systematically searched Pubmed, Web of Science, and the Cochrane Database, as well as abstracts presented at conferences (all up to January 2015), for randomized-controlled and nonrandomized clinical trials that compared cisplatin-based and nedaplatin-based regimens in patients with metastatic/recurrent or advanced ESCC...
November 21, 2016: Diseases of the Esophagus: Official Journal of the International Society for Diseases of the Esophagus
https://www.readbyqxmd.com/read/27868231/aprepitant-in-pediatric-patients-using-moderate-and-highly-emetogenic-protocols-a-systematic-review-and-meta-analyses-of-randomized-controlled-trials
#16
Lucas Miyake Okumura, Fernanda D' Athayde Rodrigues, Maria Angelica Pires Ferreira, Leila Beltrami Moreira
AIMS: To review the efficacy and safety of aprepitant in combination with ondansetron and dexamethasone (triple therapy) in children and adolescents on moderate to highly emetogenic chemotherapy. METHODS: Medline, Embase, Scielo, Lilacs, Cochrane and congress abstracts published until September 2016 were used as data sources. Two reviewers independently selected manuscripts and extracted data. A third reviewer solved discrepancies in study's selection and data extraction...
November 20, 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27858906/combination-of-125i-brachytherapy-and-chemotherapy-for-unresectable-recurrent-breast-cancer-a-retrospective-control-study
#17
Qixing Tan, Qinghong Qin, Weiping Yang, Bin Lian, Qinguo Mo, Changyuan Wei
Recurrent breast cancer remains an incurable malignancy and cannot be removed by surgery in the majority of cases. This study aimed to explore the feasibility and efficacy of the combination of I brachytherapy and chemotherapy for the treatment of unresectable recurrent breast cancer. Patients with unresectable recurrent breast cancer treated between January 2011 and December 2014 with a combination of I brachytherapy and capecitabine or gemcitabine were evaluated and outcomes were compared with those of women treated with capecitabine or gemcitabine in conventional dose as a monotherapy...
November 2016: Medicine (Baltimore)
https://www.readbyqxmd.com/read/27852418/-comparisons-of-efficacy-and-safety-of-levetiracetam-versus-phenytoin-for-seizure-prophylaxis-in-patients-with-brain-injury-a-meta-analysis
#18
J N Li, Y M Chen
Objective: To systematically review the efficacy, side effects and case-fatality rate of levetiracetam (LEV) versus phenytoin (PHT) for seizure prophylaxis of brain injured patients. Methods: Randomized controlled trials of high quality about LEV versus PHT in seizure prophylaxis of brain injured patients from 2000 to 2016 were collected according to the key word PHT, LEV, brain injury in PubMed, Medline, Ovid, Springer, CNKI, Wanfang data and so on. Valid data were extracted to conduct meta-analysis by RevMan 5...
October 25, 2016: Zhonghua Yi Xue za Zhi [Chinese medical journal]
https://www.readbyqxmd.com/read/27852042/toxicity-profile-of-approved-anti-pd-1-monoclonal-antibodies-in-solid-tumors-a-systematic-review-and-meta-analysis-of-randomized-clinical-trials
#19
REVIEW
Ricardo Costa, Benedito A Carneiro, Mark Agulnik, Alfred W Rademaker, Sachin G Pai, Victoria M Villaflor, Massimo Cristofanilli, Jeffrey A Sosman, Francis J Giles
PURPOSE: Nivolumab and pembrolizumab are antibodies against the programmed-death-receptor- 1 (PD-1) which are associated with distinct immune related adverse effects (AEs). This meta-analysis of randomized clinical trials aims to summarize current knowledge regarding the toxicity profile of these agents. METHODS: PubMed search was conducted in February of 2016. The randomized trials needed to have at least one of the study arms consisting of nivolumab or pembrolizumab monotherapy and a control arm containing no anti-PD-1 therapy...
November 11, 2016: Oncotarget
https://www.readbyqxmd.com/read/27852036/interim-analysis-of-a-phase-i-iia-trial-assessing-e39-gm-csf-a-folate-binding-protein-vaccine-to-prevent-recurrence-in-ovarian-and-endometrial-cancer-patients
#20
Doreen O Jackson, Kevin Byrd, Timothy J Vreeland, Diane F Hale, Garth S Herbert, Julia M Greene, Erika J Schneble, John S Berry, Alfred F Trappey, G T Clifton, Mark O Hardin, Jonathan Martin, John C Elkas, Thomas P Conrads, Kathleen M Darcy, Chad A Hamilton, George L Maxwell, George E Peoples
BACKGROUND: Folate binding protein(FBP) is an immunogenic protein over-expressed in endometrial(EC) and ovarian cancer(OC). We are conducting a phase I/IIa trial of E39 (GALE 301)+GM-CSF, an HLA-A2-restricted, FBP-derived peptide vaccine to prevent recurrences in disease-free EC and OC patients. This interim analysis summarizes toxicity, immunologic responses, and clinical outcomes to date. METHODS: HLA-A2+ patients were vaccinated(VG), and HLA-A2- or -A2+ patients were followed as controls(CG)...
November 11, 2016: Oncotarget
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