{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,7]],"date-time":"2026-02-07T09:29:09Z","timestamp":1770456549989,"version":"3.49.0"},"reference-count":36,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2021,1,14]],"date-time":"2021-01-14T00:00:00Z","timestamp":1610582400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Nutr."],"abstract":"<jats:p><jats:bold>Background:<\/jats:bold> New clinical trials in cancer cachexia are essential, and outcome measures with high responsiveness to detect meaningful changes are crucial. This secondary analysis from a multimodal intervention trial estimates sensitivity to change and between treatment effect sizes (ESs) of outcome measures associated with body composition, physical function, metabolism, and trial intervention.<\/jats:p><jats:p><jats:bold>Methods:<\/jats:bold> The study was a multicenter, open-label, randomized pilot study investigating the feasibility of a 6-week multimodal intervention [exercise, non-steroidal anti-inflammatory drugs, and oral nutritional supplements containing polyunsaturated fatty acids (<jats:italic>n<\/jats:italic>\u22123 PUFAs)] vs. standard cancer care in non-operable non-small-cell lung cancer and advanced pancreatic cancer. Body composition measures from computerized tomography scans and circulating biomarkers were analyzed.<\/jats:p><jats:p><jats:bold>Results:<\/jats:bold> Forty-six patients were randomized, and the analysis included 22 and 18 patients in the treatment and control groups, respectively. The between-group ESs were high for body weight (ES = 1.2, <jats:italic>p<\/jats:italic> &amp;lt; 0.001), small for body composition and physical function [handgrip strength (HGS)] measures (ES &amp;lt; 0.25), moderate to high for n-3 PUFAs and 25-hydroxyvitamin D (25-OH vitamin D) (ES range 0.64\u20131.37, <jats:italic>p<\/jats:italic> &amp;lt; 0.05 for all), and moderate for serum C-reactive protein (ES = 0.53, <jats:italic>p<\/jats:italic> = 0.12). Analysis within the multimodal treatment group showed high sensitivity to change for adiponectin (ES = 0.86, <jats:italic>p<\/jats:italic> = 0.001) and n-3 PUFAs (ES &amp;gt; 0.8, <jats:italic>p<\/jats:italic> &amp;lt; 0.05 for all) and moderate for 25-OH vitamin D (ES = 0.49, <jats:italic>p<\/jats:italic> = 0.03). In the control group, a moderate sensitivity to change for body weight (ES = \u22120.84, <jats:italic>p<\/jats:italic> = 0.002) and muscle mass (ES = \u22120.67, <jats:italic>p<\/jats:italic> = 0.016) and a high sensitivity to change for plasma levels of 25-OH vitamin D (ES = \u22120.88, <jats:italic>p<\/jats:italic> = 0.002) were found.<\/jats:p><jats:p><jats:bold>Conclusion:<\/jats:bold> Demonstrating high sensitivity to change and between treatment ES and body composition measures, body weight still stands out as a clinical and relevant outcome measure in cancer cachexia. Body composition and physical function measures clearly are important to address but demand large sample sizes to detect treatment group differences.<\/jats:p><jats:p><jats:bold>Trial registration:<\/jats:bold><jats:ext-link>ClinicalTrials.gov<\/jats:ext-link> identifier: NCT01419145.<\/jats:p>","DOI":"10.3389\/fnut.2020.602775","type":"journal-article","created":{"date-parts":[[2021,1,14]],"date-time":"2021-01-14T16:27:11Z","timestamp":1610641631000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":14,"title":["Power Comparisons and Clinical Meaning of Outcome Measures in Assessing Treatment Effect in Cancer Cachexia: Secondary Analysis From a Randomized Pilot Multimodal Intervention Trial"],"prefix":"10.3389","volume":"7","author":[{"given":"Trude R.","family":"Balstad","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cinzia","family":"Brunelli","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Caroline H.","family":"Pettersen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Svanhild A.","family":"Sch\u00f8nberg","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Frank","family":"Skorpen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marie","family":"Fallon","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stein","family":"Kaasa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Asta","family":"Bye","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Barry J. 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