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The goal of the current study was to determine whether specialized, nutrition\u2010focused patient care could improve integrated whole\u2010body metabolism and functional outcome in unselected weight\u2010losing patients with malignant disease who were receiving systemic antiinflammatory (cyclooxygenase [COX]\u2010inhibitory) treatment along with erythropoietin (EPO) support.<\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS<\/jats:title><jats:p>Three hundred nine patients with malignant disease who experienced progressive cachexia due to solid tumors (primarily gastrointestinal lesions) were randomized to receive a COX inhibitor (indomethacin, 50 mg twice daily) and EPO (15\u201340,000 units per week) along with specialized, nutrition\u2010focused patient care (oral nutritional support and home total parenteral nutrition [TPN]) provided on a patient\u2010by\u2010patient basis to attenuate inflammation, prevent anemia, and improve nutritional status. Control patients received the same indomethacin and EPO doses that study patients received without the added nutritional support. All patients were treated and followed until death. Biochemical assays (blood, liver, kidney, and thyroid), nutritional state assessment (food intake and body composition), and exercise testing with simultaneous measurement of whole\u2010body respiratory gas exchange before and during exercise were performed before the start of treatment and then at regular intervals during the treatment period (every 2\u201330 months after treatment initiation). Statistical analyses were performed on \u2018intention\u2010to\u2010treat\u2019 and \u2018as\u2010treated\u2019 bases.<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p>Home TPN was provided to approximately 50% of the study patients without severe complications. Over the entire observation period, rhEPO prevented the development of anemia in both study patients and control patients. Intention\u2010to\u2010treat analysis revealed an improvement in energy balance for nutritionally supported patients (<jats:italic>P<\/jats:italic> &lt; 0.03); no other significant differences in outcome between study patients and control patients were observed. As\u2010treated analysis demonstrated that patients receiving nutrition experienced prolonged survival (<jats:italic>P<\/jats:italic> &lt; 0.01), which was accompanied by improved energy balance (<jats:italic>P<\/jats:italic> &lt; 0.001), increasing body fat (<jats:italic>P<\/jats:italic> &lt; 0.05), and a greater maximum exercise capacity (<jats:italic>P<\/jats:italic> &lt; 0.04). A trend toward increased metabolic efficiency at maximum exercise (<jats:italic>P<\/jats:italic> &lt; 0.06) for study patients relative to control patients also was observed.<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSIONS<\/jats:title><jats:p>The results of the current study strongly support that nutrition is a limiting factor influencing survival and that nutritional support protects integrated metabolism and metabolic function in patients with progressive cachexia secondary to malignant disease. Cancer 2004. \u00a9 2004 American Cancer Society.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cncr.20160","type":"journal-article","created":{"date-parts":[[2004,4,15]],"date-time":"2004-04-15T19:05:48Z","timestamp":1082055948000},"page":"1967-1977","source":"Crossref","is-referenced-by-count":195,"title":["Palliative nutritional intervention in addition to cyclooxygenase and erythropoietin treatment for patients with malignant disease: Effects on survival, metabolism, and 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