#B198 Cancer Related Anorexia/Cachexia (CACS) and Oxidative Stress: An Innovative Approach Beyond Current Treatment. Giovanni Mantovani, Antionio Maccio, Clelia Madeddu, Giulia Gramignano, Maria R. Lusso, Elena Massa, Giorgio Astara, Luca Ferreli, Roberto Serpe, Department of Medical Oncology, University of Cagliari, Cagliari, Italy. Background: Cancer Anorexia/Cachexia Syndrome (CACS) and Oxidative Stress (OS) play a key role in the progression and outcome of neoplastic disease. Methods: On the basis of our previously published studies and clinical experience we have developed an innovative approach consisting of: diet with high polyphenols content (400 mg), oral pharmaco-nutritional support enriched with n-3 PUFA (EPA,DHA) 2 cans (237 ml each)/day, medroxiprogesterone acetate 500 mg/day, antioxidant treatment with alpha lipoic acid 300 mg/day + carbocysteine lysine salt 2.7 g/day + vitamin E 400 mg/day + vitamin A 30000 IU/day + vitamin C 500 mg/day, selective COX-2 inhibitor Celecoxib 200 mg/day. The treatment is administered for 16 weeks. The following parameters are evaluated: 1) clinical (stage and ECOG PS); 2) nutritional (Lean Body Mass-LBM, appetite and resting energy expenditure) ; 3) laboratory parameters (serum levels of proinflammatory cytokines, CRP and leptin and blood levels of reactive oxygen species (ROS) and antioxidant enzymes); 4) quality of life (EORTC QLQ-C30, EQ-5D and EQ-5Dvas). A phase II non randomized study has been designed to enroll 40 patients with advanced cancer at different sites with symptoms of CACS/OS. Results: To date (June 2003) 17 patients have been enrolled (9 head and neck, 4 breast, 1 ovarian, 1 lung, 1 stomach and 1 pancreatic ca; all stage IV).16 patients are evaluable: 5 patients have been evaluated after 4 months of treatment, 13 after 2 months and 16 after 1 month. As for LBM a mean increase of 1.0 kg (+4.8%) after 1 month, 3.9 kgs (+15.5%, p<0.05) after 2 months and 6.0 kgs (+27.4%, p<0.05) after 4 months has been recorded. TNF alpha significantly decreased (p<0.05) after 1 month, 2 months and 4 months of treatment. As for ROS a significant decrease (p<0.05) after 2 months and 4 months of treatment has been recorded. The evaluation of QL showed a mean percent improvement of 29.9 by EORTC QLQ-C30 and 20.8% by EQ-5Dvas after 1 month of treatment. Conclusions: The treatment has demonstrated to be effective as for: increase of LBM, decrease of proinflammatory cytokines, improvement of Quality of life. The treatment has demonstrated to be safe with good compliance of patients. The study is in progress until the accrual will be completed. Work supported by Special Program for Exp Res, Prevention and Medical Education funded by RAS, Italy, 2002. Frontiers in Cancer Prevention Research, 2003 AACR Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.