Methodologic lessons learned from hot flash studies

J. A. Sloan, C. L. Loprinzi, P. J. Novotny, D. L. Barton, B. I. Lavasseur, H. Windschitl

Research output: Contribution to journalArticle

367 Scopus citations

Abstract

Purpose: In the course of conducting a series of prospective clinical trials devoted to defining new treatment opportunities for hot flashes in cancer survivors, considerable experience has been acquired with related methodologic issues. This article has been written in response to many queries regarding this methodology. Patients and Methods: A series of seven different clinical trials that involved 968 patients was used for this work. Reliable and valid definitions of hot flash intensity were developed from patient-reported descriptions. Concomitant validity and reliability assessment of patient-completed diaries was undertaken to compare hot flash data with toxicity and quality-of-life (QOL) end points and to examine consistency across patient groups using variability analysis and correlation procedures. Parametric data from this meta-analysis was used to examine relative power considerations for the design of phase II and phase III clinical trials. Results: Daily diaries used in these studies exhibited consistency and reliability and had few missing data. Hot flash frequency and hot flash score (frequency multiplied by average severity) variables produced almost identical end point results. For phase III placebo-controlled studies, 50 patients per treatment arm seem appropriate to provide sufficient power specifications to detect a clinically meaningful change in hot flash activity. For phase II trials, 25 patients per trial seem to provide reasonable estimates of eventual hot flash efficacy to screen potential agents for more definitive testing. Conclusion: Given the data gained from these experiences, we can plan and carry out more efficient trials to identify efficacious agents for the reduction of hot flash activity.

Original languageEnglish (US)
Pages (from-to)4280-4290
Number of pages11
JournalJournal of Clinical Oncology
Volume19
Issue number23
DOIs
StatePublished - Dec 1 2001

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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