Effect Of Whey Protein Isolate Supplementation On Body Composition, Muscle Strength, And Treatment Tolerance In Malnourished Advanced Cancer Patients Undergoing Chemotherapy.

11598 Background: Malnutrition is frequent in cancer pts, particularly in advanced disease, which requires appropriate multidisciplinary interventions. We evaluated the benefit of whey protein isolate (WPI) supplementation in addition to nutritional counseling in malnourished cancer pts undergoing chemotherapy (CT). Methods: In a single-center, randomized, pragmatic, parallel-group controlled trial (ClinicalTrials.gov: NCT02065726), 166 malnourished advanced cancer pts undergoing CT were randomly assigned to receive nutritional counseling with (N=82) or without (N=84) WPI supplementation (20 grams/daily) for 3 months. Primary endpoint was the change in phase angle (PhA). Secondary endpoints included changes in standardized PhA (SPA), fat-free mass index (FFMI), body weight, muscle strength, quality of life and CT toxicity. Results: In pts with the primary endpoint assessed (modified intention-to-treat population), counseling plus WPI (N=66) resulted in improved PhA compared to nutritional counseling alone (N=69): mean difference, 0.48° [95%CI, 0.05 to 0.90] (P=0.027). Imputation of missing outcomes yielded consistent findings. WPI supplementation resulted also in improved SPA (P=0.021), FFMI (P=0.041), body weight (P=0.023), muscle strength (P<0.001) and in reduced risk of CT toxicity, particularly of severe (grade ≥3) events (Table). Conclusions: In malnourished advanced cancer patients undergoing CT and receiving nutritional counseling, 3-month supplementation with WPI resulted in improved body composition, muscle strength, body weight and reduced CT toxicity. Further trials in newly diagnosed specific cancer types are warranted. Clinical trial information: NCT02065726. [Table: see text]