Antioxidants: A Phase II Study with Antioxidants, both in terms of diet and supplementation, Pharmaconutritionele support, Progestagen, and Anti-Cyclooxygenase-2 shows a significant positive effect and safety in preventing weight loss and oxidative stress in patients with advanced cancer. Article updated April 4, 2011
May 18, 2006: Source: Cancer Epidemiol Biomarkers Prev. 2006 May; 15 (5) :1030-4.A Phase II Study with Antioxidants, both in terms of diet and supplementation, Pharmaconutritionele support, Progestagen, and Anti-Cyclooxygenase-2 shows a significant positive impact on safety and prevention of weight loss and oxidative stress in patients with advanced cancer.
RESULTS: From July 2002 until January 2005, 44 patients took part in this study. 39 of them completed the entire study and were available for study measurements. Body weight increased significantly in both body mass weight and feel like eating. There was a significant reduction preontstekings cytokines interleukin-6 (IL-6) and tumor necrosis factor-alpha, and only a negative relationship seems worth noting between LBM and IL-6 changes. For the quality of life assessment was a significant improvement compared with the directives of the European Organization for Research and Treatment of Cancer QLQ-C30, Euro QL-5D (VAS) and multidimensional fatigue symptom inventory scores. At the end of the study were 22 of 39 patients "responders" or "high responders." The minimum requirement was 21, so the treatment was very effective and important adjuvant therapy was also safe.
A Phase II Study with Antioxidants, Both in the Diet and Supplemented, Pharmaconutritional Support Progestagen, and Anti-Cyclooxygenase-2 Showing Efficacy and Safety in Patients with Cancer-Related Anorexia / Cachexia and Oxidative Stress.
Mantovani G, Maccio A, Madeddu C, Gramignano G, Lusso MR, Serpe R, Massa E, Astara G, Deiana L.
Division e Cattedra di Oncología Medica, Universita di Cagliari, Policlinico Universitario, Presidio di Monserrato, SS 554, KM 4.500, 09042 Monserrato, Cagliari, Italy. mantovan@pacs.unica.it.
PURPOSE: To test the efficacy and safety of an integrated treatment based on a pharmaconutritional support, antioxidants, and drugs, all Given orally, in a population of advanced cancer patients with cancer-related anorexia / cachexia and oxidative stress.
Patients and METHODS: An open early-phase II study was designed According To the Simon two-stage design. The integrated treatment consisted of diet with high polyphenols content (400 mg), antioxidant treatment (300 mg / d alpha-lipoic acid + 2.7 g / d carbocysteine lysine salt + 400 mg / d vitamin E + 30,000 IU / d vitamin A + 500 mg / d vitamin C), and pharmaconutritional support enriched with 2 cans per day (n-3)-PUFA (eicosapentaenoic acid and docosahexaenoic acid) 500 mg / d medroxyprogesterone acetate, and 200 mg / d selective cyclooxygenase-2 inhibitor celecoxib. The treatment duration was four months. Were Evaluated the following variables: (a) clinical (Eastern Cooperative Oncology Group performance status), (b) nutritional [lean body mass (LBM), appetite, and resting energy Expenditure] (c) laboratory [proinflammatory cytokines and leptin, reactive oxygen species (ROS) and antioxidant enzymes] (d) quality of life (European Organization for Research and Treatment of Cancer QLQ-C30, Euro QL-5D, and SF-MFSI).
RESULTS: From July 2002 to January 2005, 44 patients Were enrolled. Or thesis, 39 completed the treatment and Were assessable. Increased body weight significantly from baseline as did LBM and appetite. There was an important Decrease proinflammatory cytokines and interleukin-6 (IL-6) and tumor necrosis factor-alpha, and a negative relationship worthy of note was found only Between LBM and IL-6 changes. Axis for Quality of Life evaluation, there was a marked improvement in the European Organization for Research and Treatment of Cancer QLQ-C30, Euro QL-5D (VAS) and multidimensional fatigue symptom inventory-short form scores. At the end of the study, 22 of the 39 patients were "responders" or "high responders." The minimum required was 21, therefore, the treatment was effective and more importantly was Shown to be safe.
CONCLUSION: The efficacy and safety of the treatment have leg Shown by the study, therefore, a randomized phase III study is warranted. (Cancer Epidemiol Biomarkers Prev 2006, 15 (5) :1030-4).
PMID: 16702388 [PubMed - in process]




