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dc.contributor.authorVagnildhaug, Ola Magne
dc.contributor.authorBalstad, Trude Rakel
dc.contributor.authorOttestad, Inger
dc.contributor.authorBye, Asta
dc.contributor.authorGreil, Christine
dc.contributor.authorArends, Jann
dc.contributor.authorBaracos, Vickie
dc.contributor.authorBrown, Leo R.
dc.contributor.authorDajani, Olav
dc.contributor.authorDolan, Ross D.
dc.contributor.authorFallon, Marie
dc.contributor.authorFraser, Eilidh
dc.contributor.authorGrzyb, Aleksandra
dc.contributor.authorHjermstad, Marianne Jensen
dc.contributor.authorJakobsen, Gunnhild
dc.contributor.authorKaasa, Stein
dc.contributor.authorMcDonald, James
dc.contributor.authorPhilips, Iain
dc.contributor.authorSayers, Judith
dc.contributor.authorSimpson, Melanie Rae
dc.contributor.authorSousa, Mariana S.
dc.contributor.authorSkipworth, Richard J.E.
dc.contributor.authorLaird, Barry J.A.
dc.contributor.authorSolheim, Tora S
dc.date.accessioned2024-08-29T08:52:58Z
dc.date.available2024-08-29T08:52:58Z
dc.date.issued2024-02-11
dc.description.abstractThere is no consensus on the optimal endpoint(s) in cancer cachexia trials. Endpoint variation is an obstacle when compar ing interventions and their clinical value. The aim of this systematic review was to summarize and evaluate endpoints used to assess appetite and dietary intake in cancer cachexia clinical trials. A search for studies published from 1 January 1990 until 2 June 2021 was conducted using MEDLINE, Embase and Cochrane Central Register of Controlled Trials. Eligible studies examined cancer cachexia treatment versus a comparator in adults with assessments of appetite and/or dietary in take as study endpoints, a sample size ≥40 and an intervention lasting ≥14 days. Reporting was in line with PRISMA guid ance, and a protocol was published in PROSPERO (2022 CRD42022276710). This review is part of a series of systematic reviews examining cachexia endpoints. Of the 5975 articles identified, 116 were eligible for the wider review series and 80 specifically examined endpoints of appetite (65 studies) and/or dietary intake (21 studies). Six trials assessed both appetite and dietary intake. Appetite was the primary outcome in 15 trials and dietary intake in 7 trials. Median sample size was 101 patients (range 40–628). Forty-nine studies included multiple primary tumour sites, while 31 studies involved single primary tumour sites (15 gastrointestinal, 7 lung, 7 head and neck and 2 female reproductive organs). The most fre quently reported appetite endpoints were visual analogue scale (VAS) and numerical rating scale (NRS) (40%). The appe tite item from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30/C15 PAL (38%) and the appetite question from North Central Cancer Treatment Group anorexia questionnaire (17%) were also frequently applied. Of the studies that assessed dietary intake, 13 (62%) used food records (prospective registrations) and 10 (48%) used retrospective methods (24-h recall or dietary history). For VAS/NRS, a mean change of 1.3 corresponded to Hedge’s g of 0.5 and can be considered a moderate change. For food records, a mean change of 231 kcal/day or 11 g of protein/day corresponded to a moderate change. Choice of endpoint in cachexia trials will depend on factors pertinent to the trial to be conducted. Nevertheless, from trials assessed and available literature, NRS or EORTC QLQ C30/C15 PAL seems suitable for appetite assessments. Appetite and dietary intake endpoints are rarely used as rimary outcomes in cancer cachexia. Dietary intake assessments were used mainly to monitor compliance and are not val idated in cachexia populations. Given the importance to cachexia studies, dietary intake endpoints must be validated before they are used as endpoints in clinical trials.en_US
dc.identifier.citationVagnildhaug, Balstad, Ottestad, Bye, Greil, Arends, Baracos, Brown, Dajani, Dolan, Fallon, Fraser, Grzyb, Hjermstad, Jakobsen, Kaasa, McDonald, Philips, Sayers, Simpson, Sousa, Skipworth, Laird, Solheim. Appetite and dietary intake endpoints in cancer cachexia clinical trials: Systematic Review 2 of the cachexia endpoints series. Journal of Cachexia, Sarcopenia and Muscle. 2024en_US
dc.identifier.cristinIDFRIDAID 2250254
dc.identifier.doi10.1002/jcsm.13434
dc.identifier.issn2190-5991
dc.identifier.issn2190-6009
dc.identifier.urihttps://hdl.handle.net/10037/34453
dc.language.isoengen_US
dc.publisherWileyen_US
dc.relation.journalJournal of Cachexia, Sarcopenia and Muscle
dc.rights.accessRightsopenAccessen_US
dc.rights.holderCopyright 2024 The Author(s)en_US
dc.rights.urihttps://creativecommons.org/licenses/by/4.0en_US
dc.rightsAttribution 4.0 International (CC BY 4.0)en_US
dc.titleAppetite and dietary intake endpoints in cancer cachexia clinical trials: Systematic Review 2 of the cachexia endpoints seriesen_US
dc.type.versionpublishedVersionen_US
dc.typeJournal articleen_US
dc.typeTidsskriftartikkelen_US
dc.typePeer revieweden_US


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