Chapter

Methodological Issues Regarding Cancer Anorexia/Cachexia Trials

Russell K. Portenoy and Eduardo Bruera

in Issues in Palliative Care Research

Published in print September 2003 | ISBN: 9780195130652
Published online November 2011 | e-ISBN: 9780199999842 | DOI: http://dx.doi.org/10.1093/acprof:oso/9780195130652.003.0002
Methodological Issues Regarding Cancer Anorexia/Cachexia Trials

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This chapter reviews information regarding conducting and analyzing trials designed to test potential agents for alleviating cancer-related anorexia/cachexia. The information was derived from experience generated by the North Central Cancer Treatment Group (NCCTG) in conducting a series of ten trials which, to date, have entered over 2000 patients. As with any research endeavor, the study of anorexia/cachexia is difficult and fraught with potential pitfalls. The discussion here may aid in the standardization of design and analytic approaches for anorexia/cachexia trials so that a meta-analytic process, formal or otherwise, may be facilitated. The overriding principle has been to keep the process as simple as possible due to the many potentially concomitant confounding influences. If the treatments applied to anorexia/cachexia do not produce profound results in the presence of substantial systemic noise, then they are not likely to be seen as efficacious in the community clinical environment beyond the clinical trials setting.

Keywords: eating disorder; cancer-related anorexia; North Central Cancer Treatment Group; design standardization; clinical trials; systemic noise

Chapter.  5931 words.  Illustrated.

Subjects: Palliative Medicine

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