Safety and Tolerability of Targeted Medical Nutrition for Cachexia in Non-Small-Cell Lung Cancer: A Randomized, Double-Blind, Controlled Pilot Trial.

Abstract

Background: 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.

• Authors: Alessandro Laviano, Philip C Calder, Annemie M W J Schols, Fredrik Lonnqvist, Maria Bech, Maurizio Muscaritoli
• Journal: Nutrition and cancer (Nutr Cancer) Vol. 72 Issue 3 Pg. 439-450 ( 2020) ISSN: 1532-7914 [Electronic] United States
• PMID: 31290697 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents
• Whey Proteins
• Docosahexaenoic Acids
• Eicosapentaenoic Acid
• Calcifediol

Topics

• Aged
• Antineoplastic Agents (therapeutic use)
• Body Weight (drug effects)
• Cachexia (complications, diet therapy)
• Calcifediol (administration & dosage, adverse effects)
• Carcinoma, Non-Small-Cell Lung (complications, drug therapy)
• Dietary Supplements (adverse effects, statistics & numerical data)
• Docosahexaenoic Acids (administration & dosage, adverse effects)
• Double-Blind Method
• Eicosapentaenoic Acid (administration & dosage, adverse effects)
• Female
• Humans
• Lung Neoplasms (complications, drug therapy)
• Male
• Middle Aged
• Neutropenia (complications)
• Pilot Projects
• Treatment Outcome
• Weight Loss
• Whey Proteins (administration & dosage, adverse effects)