title: Weight loss versus muscle loss: re-evaluating inclusion criteria for future cancer cachexia interventional trials.
abstract: Participation in cancer cachexia clinical trials requires a defined weight loss (WL) over time. A loss in skeletal muscle mass, measured by cross-sectional computed tomography (CT) image analysis, represents a possible alternative. Our aim was to compare WL versus muscle loss in patients who were screened to participate in a cancer cachexia clinical trial.
  
  
  
  This was a single-center, retrospective analysis in metastatic colorectal cancer patients screened for an interventional cancer cachexia trial requiring a ≥5 % WL over the preceding 6 months. Concurrent CT images obtained as part of standard oncology care were analyzed for changes in total muscle and fat (visceral, subcutaneous, and total).
  
  
  
  Of patients screened (n = 36), 3 (8 %) enrolled in the trial, 17 (47 %) were excluded due to insufficient WL (<5 %), 3 (8 %) were excluded due to excessive WL (>20 %), and 16 (44 %) met inclusion criteria for WL. Patients who met screening criteria for WL (5-20 %) had a mean ± SD of 7.7 ± 8.7 % muscle loss, 24.4 ± 37.5 % visceral adipose loss, 21.6 ± 22.3 % subcutaneous adipose loss, and 22.1 ± 24.7 % total adipose loss. Patients excluded due to insufficient WL had 2 ± 6.4 % muscle loss, but a gain of 8.5 ± 39.8 % visceral adipose, and 4.2 ± 28.2 % subcutaneous adipose loss and 0.8 ± 28.4 % total adipose loss. Of the patients excluded due to WL <5 % (n = 17), 7 (41 %) had a skeletal muscle loss >5 %.
  
  
  
  Defining cancer cachexia by WL over time may be limited as it does not capture skeletal muscle loss. Cross-sectional CT body composition analysis may improve early detection of muscle loss and patient participation in future cancer cachexia clinical trials.
authors.affiliation: Oncology and Palliative Care, University of California, San Diego (UC San Diego), La Jolla, CA, 92093, USA. eroeland@ucsd.edu.
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Roeland
authors.affiliation: Skaggs School of Pharmacy & Pharmaceutical Sciences, UC San Diego, La Jolla, CA, USA.
authors.forename: Joseph D
authors.initials: JD
authors.lastname: Ma
authors.affiliation: Department of Cancer Prevention and Control, UC San Diego Moores Cancer Center, La Jolla, CA, USA.
authors.forename: Sandahl H
authors.initials: SH
authors.lastname: Nelson
authors.affiliation: Oncology and Palliative Care, University of California, San Diego (UC San Diego), La Jolla, CA, 92093, USA.
authors.forename: Tyler
authors.initials: T
authors.lastname: Seibert
authors.affiliation: Oncology and Palliative Care, University of California, San Diego (UC San Diego), La Jolla, CA, 92093, USA.
authors.forename: Sean
authors.initials: S
authors.lastname: Heavey
authors.affiliation: Oncology and Palliative Care, University of California, San Diego (UC San Diego), La Jolla, CA, 92093, USA.
authors.forename: Carolyn
authors.initials: C
authors.lastname: Revta
authors.affiliation: Department of Oncology, University of Alberta, Edmonton, AB, Canada.
authors.forename: Andrea
authors.initials: A
authors.lastname: Gallivan
authors.affiliation: Department of Oncology, University of Alberta, Edmonton, AB, Canada.
authors.forename: Vickie E
authors.initials: VE
authors.lastname: Baracos
mesh_terms: D001823:Body Composition / Q000502:physiology*; D002100:Cachexia / Q000175:diagnosis*; D015179:Colorectal Neoplasms / Q000150:complications* / Q000473:pathology; D003430:Cross-Sectional Studies; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018482:Muscle, Skeletal / Q000473:pathology / Q000502:physiology*; D012189:Retrospective Studies; D015431:Weight Loss / Q000502:physiology*
keywords: Cachexia; Cancer; Interventional trials; Muscle loss; Weight loss