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Safety and tolerability of targeted medical nutrition for cachexia in non-small-cell lung cancer: a randomized, double-blind, controlled pilot trial

Safety and tolerability of targeted medical nutrition for cachexia in non-small-cell lung cancer: a randomized, double-blind, controlled pilot trial
Safety and tolerability of targeted medical nutrition for cachexia in non-small-cell lung cancer: a randomized, double-blind, controlled pilot trial
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.

0163-5581
439-450
Laviano, Alessandro
ac244136-413b-4734-a433-ffac1169f6bd
Calder, Philip
1797e54f-378e-4dcb-80a4-3e30018f07a6
Schols, Annemie
fc953150-9ff4-4cfd-940f-f3d97d63aa81
Lonnqvist, Fredrik
d508d3ec-f937-4d65-b781-2fa7c75fb6f2
Bech, Maria
404a3fed-45e3-406f-93c9-ad1656dd51fa
Muscaritoli, Maurizio
c7454440-43c5-4880-bda4-16b5e6c820f4
Laviano, Alessandro
ac244136-413b-4734-a433-ffac1169f6bd
Calder, Philip
1797e54f-378e-4dcb-80a4-3e30018f07a6
Schols, Annemie
fc953150-9ff4-4cfd-940f-f3d97d63aa81
Lonnqvist, Fredrik
d508d3ec-f937-4d65-b781-2fa7c75fb6f2
Bech, Maria
404a3fed-45e3-406f-93c9-ad1656dd51fa
Muscaritoli, Maurizio
c7454440-43c5-4880-bda4-16b5e6c820f4

Laviano, Alessandro, Calder, Philip, Schols, Annemie, Lonnqvist, Fredrik, Bech, Maria and Muscaritoli, Maurizio (2020) Safety and tolerability of targeted medical nutrition for cachexia in non-small-cell lung cancer: a randomized, double-blind, controlled pilot trial. Nutrition and Cancer, 72 (3), 439-450. (doi:10.1080/01635581.2019.1634746).

Record type: Article

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.

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NSCLC manuscript NC R2R_17Apr2019_accepted - Accepted Manuscript
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Safety and Tolerability of Targeted Medical Nutrition for Cachexia in Non Small Cell Lung Cancer A Randomized Double Blind Controlled Pilot Trial - Version of Record
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More information

Accepted/In Press date: 17 June 2019
e-pub ahead of print date: 10 July 2019
Published date: 2 April 2020

Identifiers

Local EPrints ID: 432741
URI: http://eprints.soton.ac.uk/id/eprint/432741
ISSN: 0163-5581
PURE UUID: 362b6fb2-f3ff-41de-b1ae-300702e3dca7
ORCID for Philip Calder: ORCID iD orcid.org/0000-0002-6038-710X

Catalogue record

Date deposited: 25 Jul 2019 16:30
Last modified: 26 Nov 2021 02:38

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Contributors

Author: Alessandro Laviano
Author: Philip Calder ORCID iD
Author: Annemie Schols
Author: Fredrik Lonnqvist
Author: Maria Bech
Author: Maurizio Muscaritoli

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