The effectiveness of nutritional-sensitive approach to restore physical activity in cachexic female palliative patients: A randomized controlled trial.

Abstract

258 Background: Loss of lean body mass, body fat along with inflammation characterizes cachexia in patients with cancer. Nutrition intervention with counseling may ameliorate undernutrition and metabolic alterations. The aim of this study was to improve nutritional status and quality of life by providing nutrients dense natural food (IAtta) along with counseling. Methods: Female patients with cancerwith symptoms of cachexia were randomly distributed into placebo (n = 75) and intervention group (n = 75). Patients were recruited from the palliative clinic, Oncology department in AIIMS, New Delhi, India. In addition to nutritional counseling, patients were instructed to consume 100g nutritional supplement on daily basis with their normal dietary intake and for six months period. The intervention group received 100g of IAtta while placebo group received 100g of whole wheat flour. Body weight – BW; mid upper arm circumference - MUAC, physical activity level - PAL, quality of life – QoL domains and total body water (TBW) were assessed at baseline, three months and after six months. Study variables were analyzed using repeated-measures ANOVA and the Friedman test (P-value < 0.05; 95% confidence interval). Results: After 6 months,patients in group IAtta had significant improvement in PAL and QoL domain (global health status, p < 0.001 and fatigue, p = 0.001). Despite the decrease in BW from 43.3 ± 7.0 to 41.6 ± 5.7 Kg (p = 0.014), TBW and MUAC (p = 0.068) were maintained. Conversely, the QoL in placebo group did not improve (global health status, p = 0.74) neither their PAL. Moreover, significant increase in TBW (due to water retention) and BW (from 42.6±7.1 to 43.5±7.4 Kg, p = 0.001). Conclusions: Nutrition-sensitive approach (IAtta meal), along with nutrition counseling, improve quality of life and physical activity in female cachexia palliative patients with cancer. Clinical trial information: NCT02561143. [Table: see text]