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dc.contributor.authorBalstad, Trude Rakel
dc.contributor.authorBrunelli, Cinzia
dc.contributor.authorPettersen, Caroline Hild
dc.contributor.authorSchønberg, Svanhild Margrethe Arentz
dc.contributor.authorSkorpen, Frank
dc.contributor.authorFallon, Marie T.
dc.contributor.authorKaasa, Stein
dc.contributor.authorBye, Asta
dc.contributor.authorLaird, Barry J. A.
dc.contributor.authorStene, Guro Birgitte
dc.contributor.authorSolheim, Tora Skeidsvoll
dc.identifier.citationBalstad TR, Brunelli C, Pettersen CH, Schønberg SM, Skorpen F, Fallon MT, Kaasa S, Bye A, Laird BJA, Stene GB, Solheim TS. Power comparisons and clinical meaning of outcome measures in assessing treatment effect in cancer cachexia: secondary analysis from a randomised pilot multimodal intervention trial . Frontiers in Nutrition. 2020;7(326)en
dc.description.abstractBackground: 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. Methods: 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 (n−3 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. Results: 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, p < 0.001), small for body composition and physical function [handgrip strength (HGS)] measures (ES < 0.25), moderate to high for n-3 PUFAs and 25-hydroxyvitamin D (25-OH vitamin D) (ES range 0.64–1.37, p < 0.05 for all), and moderate for serum C-reactive protein (ES = 0.53, p = 0.12). Analysis within the multimodal treatment group showed high sensitivity to change for adiponectin (ES = 0.86, p = 0.001) and n-3 PUFAs (ES > 0.8, p < 0.05 for all) and moderate for 25-OH vitamin D (ES = 0.49, p = 0.03). In the control group, a moderate sensitivity to change for body weight (ES = −0.84, p = 0.002) and muscle mass (ES = −0.67, p = 0.016) and a high sensitivity to change for plasma levels of 25-OH vitamin D (ES = −0.88, p = 0.002) were found. Conclusion: 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.en
dc.description.sponsorshippreMENAC was funded by Liaison Committee for education, research and innovation in Central Norway; Nordic Cancer Union; Norwegian Cancer Society; St Olav Cancer Fund; Cancer Clinic, St. Olavs hospital, Trondheim University Hospital; Clinical Trials Unit (CTU), Cancer Research UK. The ONS (ProSure) was received free of charge from Abbott Nutrition.en
dc.publisherFrontiers Mediaen
dc.relation.ispartofseriesFrontiers in Nutrition; January 2021 | Volume 7 | Article 602775
dc.rightsCreative Commons Attribution 4.0 International (CC BY 4.0) Licenseen
dc.subjectMultimodal managementen
dc.subjectOutcome measuresen
dc.subjectBody compositionsen
dc.subjectEffect sizesen
dc.subjectSample sizesen
dc.titlePower comparisons and clinical meaning of outcome measures in assessing treatment effect in cancer cachexia: secondary analysis from a randomised pilot multimodal intervention trialen
dc.typeJournal articleen
dc.typePeer revieweden
dc.subject.hrcsKreft: Evaluering av behandlinger og terapeutiske intervensjoner
dc.subject.hrcsCancer : Evaluation of Treatments and Therapeutic Interventions
dc.source.journalFrontiers in Nutrition

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