Safety and Tolerability of Targeted Medical Nutrition for Cachexia in Non-Small-Cell Lung Cancer: A Randomized,Double-Blind,Controlled Pilot Trial |
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| Authors: | Alessandro Laviano Philip C. Calder Annemie M. W. J. Schols Fredrik Lonnqvist Maria Bech |
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| Affiliation: | 1. Department of Translational and Precision Medicine, Sapienza University of Rome, Rome, Italy;2. Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, UK;3. NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton, UK;4. Department of Respiratory Medicine, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, Netherlands;5. Department of Molecular Medicine and Surgery and the Centre for Molecular Medicine, Karolinska Institute, Stockholm, Sweden;6. Smartfish AS, Oslo, Norway |
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| Abstract: | ![]()
AbstractBackground: This pilot, double-blind, comparator-controlled trial evaluated the safety and tolerability of an oral targeted medical nutrition (TMN) supplement for the management of cachexia in patients with non-small-cell lung cancer (NSCLC).Methods: Patients receiving first-line chemotherapy for NSCLC with weight loss or low BMI were randomized 1:1 to receive juice-based TMN (～200?kcal; 10?g whey protein; ≥2.0?g eicosapentaenoic acid/docosahexaenoic acid in fish oil; and 10?μg 25-hydroxy-vitamin D3) or a milk-based isocaloric comparator twice daily for 12?weeks (ClinicalTrials.gov: NCT02515032). Primary endpoints included number/type of adverse events and changes in vital signs/laboratory parameters. Secondary endpoints included measures of clinical relevance. Survival was an exploratory endpoint.Results: The TMN group (n?=?26; mean 64.4?years) experienced fewer adverse events (64 vs. 87) than the comparator group (n?=?29; mean 66.0?years), including fewer cases of neutropenia (0 vs. 4). Compliance was slightly lower in the TMN (58.5%) vs. comparator group (73.6%). There were no statistically significant between-group differences in efficacy endpoints. Fewer (4 vs. 10) patients who received TMN than comparator had died by 1-year post baseline.Conclusions: TMN was well tolerated. Trends for improved clinical outcomes with TMN identified in this study warrant further investigation. |
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