Appetite and dietary intake endpoints in cancer cachexia clinical trials: Systematic Review 2 of the cachexia endpoints series.

Vagnildhaug, OM; Balstad, TR; Ottestad, I; Bye, A; Greil, C; Arends, J; Baracos, V; Brown, LR; Dajani, OF; Dolan, RD; Fallon, M; Fraser, E; Grzyb, A; Hjermstad, MJ; Jakobsen, G; Kaasa, S; McDonald, J; Philips, I; Sayers, J; Simpson, MR; Sousa, MS; Skipworth, RJE; Laird, BJA; Solheim, TS; Cancer Cachexia Endpoints Working Group,

Appetite and dietary intake endpoints in cancer cachexia clinical trials: Systematic Review 2 of the cachexia endpoints series.

Vagnildhaug, OM Balstad, TR Ottestad, I Bye, A Greil, C Arends, J Baracos, V Brown, LR Dajani, OF Dolan, RD Fallon, M Fraser, E Grzyb, A Hjermstad, MJ Jakobsen, G Kaasa, S McDonald, J Philips, I Sayers, J Simpson, MR Sousa, MS Skipworth, RJE Laird, BJA Solheim, TS Cancer Cachexia Endpoints Working Group,

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Publisher:: WILEY
Publication Type:: Journal Article
Citation:: J Cachexia Sarcopenia Muscle, 2024, 15, (2), pp. 513-535
Issue Date:: 2024-04

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Field	Value	Language
dc.contributor.author	Vagnildhaug, OM
dc.contributor.author	Balstad, TR
dc.contributor.author	Ottestad, I
dc.contributor.author	Bye, A
dc.contributor.author	Greil, C
dc.contributor.author	Arends, J
dc.contributor.author	Baracos, V
dc.contributor.author	Brown, LR
dc.contributor.author	Dajani, OF
dc.contributor.author	Dolan, RD
dc.contributor.author	Fallon, M
dc.contributor.author	Fraser, E
dc.contributor.author	Grzyb, A
dc.contributor.author	Hjermstad, MJ
dc.contributor.author	Jakobsen, G
dc.contributor.author	Kaasa, S
dc.contributor.author	McDonald, J
dc.contributor.author	Philips, I
dc.contributor.author	Sayers, J
dc.contributor.author	Simpson, MR
dc.contributor.author	Sousa, MS
dc.contributor.author	Skipworth, RJE
dc.contributor.author	Laird, BJA
dc.contributor.author	Solheim, TS
dc.contributor.author	Cancer Cachexia Endpoints Working Group,
dc.date.accessioned	2024-08-06T01:39:58Z
dc.date.available	2023-12-27
dc.date.available	2024-08-06T01:39:58Z
dc.date.issued	2024-04
dc.identifier.citation	J Cachexia Sarcopenia Muscle, 2024, 15, (2), pp. 513-535
dc.identifier.issn	2190-5991
dc.identifier.issn	2190-6009
dc.identifier.uri	http://hdl.handle.net/10453/180047
dc.description.abstract	There is no consensus on the optimal endpoint(s) in cancer cachexia trials. Endpoint variation is an obstacle when comparing 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 intake as study endpoints, a sample size ≥40 and an intervention lasting ≥14 days. Reporting was in line with PRISMA guidance, 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 frequently reported appetite endpoints were visual analogue scale (VAS) and numerical rating scale (NRS) (40%). The appetite 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 primary outcomes in cancer cachexia. Dietary intake assessments were used mainly to monitor compliance and are not validated in cachexia populations. Given the importance to cachexia studies, dietary intake endpoints must be validated before they are used as endpoints in clinical trials.
dc.format	Print-Electronic
dc.language	eng
dc.publisher	WILEY
dc.relation.ispartof	J Cachexia Sarcopenia Muscle
dc.relation.isbasedon	10.1002/jcsm.13434
dc.rights	info:eu-repo/semantics/openAccess
dc.subject	0606 Physiology, 1103 Clinical Sciences, 1106 Human Movement and Sports Sciences
dc.subject.classification	3202 Clinical sciences
dc.subject.classification	4201 Allied health and rehabilitation science
dc.subject.classification	4207 Sports science and exercise
dc.subject.mesh	Humans
dc.subject.mesh	Appetite
dc.subject.mesh	Cachexia
dc.subject.mesh	Eating
dc.subject.mesh	Neoplasms
dc.subject.mesh	Prospective Studies
dc.subject.mesh	Quality of Life
dc.subject.mesh	Retrospective Studies
dc.subject.mesh	Clinical Trials as Topic
dc.subject.mesh	Humans
dc.subject.mesh	Neoplasms
dc.subject.mesh	Cachexia
dc.subject.mesh	Retrospective Studies
dc.subject.mesh	Prospective Studies
dc.subject.mesh	Appetite
dc.subject.mesh	Eating
dc.subject.mesh	Quality of Life
dc.subject.mesh	Clinical Trials as Topic
dc.subject.mesh	Humans
dc.subject.mesh	Appetite
dc.subject.mesh	Cachexia
dc.subject.mesh	Eating
dc.subject.mesh	Neoplasms
dc.subject.mesh	Prospective Studies
dc.subject.mesh	Quality of Life
dc.subject.mesh	Retrospective Studies
dc.subject.mesh	Clinical Trials as Topic
dc.title	Appetite and dietary intake endpoints in cancer cachexia clinical trials: Systematic Review 2 of the cachexia endpoints series.
dc.type	Journal Article
utslib.citation.volume	15
utslib.location.activity	Germany
utslib.for	0606 Physiology
utslib.for	1103 Clinical Sciences
utslib.for	1106 Human Movement and Sports Sciences
pubs.organisational-group	University of Technology Sydney
pubs.organisational-group	University of Technology Sydney/Faculty of Health
pubs.organisational-group	University of Technology Sydney/Faculty of Health/IMPACCT
pubs.organisational-group	University of Technology Sydney/All Manual Groups
pubs.organisational-group	University of Technology Sydney/All Manual Groups/Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT)
utslib.copyright.status	open_access	*
dc.rights.license	This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0). To view a copy of this license, visit https://creativecommons.org/licenses/by/4.0/
dc.date.updated	2024-08-06T01:39:54Z
pubs.issue	2
pubs.publication-status	Published
pubs.volume	15
utslib.citation.issue	2

Abstract:

There is no consensus on the optimal endpoint(s) in cancer cachexia trials. Endpoint variation is an obstacle when comparing 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 intake as study endpoints, a sample size ≥40 and an intervention lasting ≥14 days. Reporting was in line with PRISMA guidance, 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 frequently reported appetite endpoints were visual analogue scale (VAS) and numerical rating scale (NRS) (40%). The appetite 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 primary outcomes in cancer cachexia. Dietary intake assessments were used mainly to monitor compliance and are not validated in cachexia populations. Given the importance to cachexia studies, dietary intake endpoints must be validated before they are used as endpoints in clinical trials.

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http://hdl.handle.net/10453/180047