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Hot Flashes Study Sections
 Author Bio
Currently selected section: Introduction 
Commentator Bio
Protocol Schema
Protocol Background
Protocol Goals
Patient Eligibility
Test Schedule
Stratification Factors
Registration/Randomization
Protocol Treatment
Dosage Modification
Ancillary Treatment
Toxicity Monitoring
Treatment Evaluation
Descriptive Factors
Treatment/Follow-up
Pharmacologic Studies
Drug Information
Statistical Considerations
Pathology Considerations
Records/Data Collection Procedures
Budget
Appendices

 

Chapter 2B: Development of a Clinical Trial for Hot Flash Protocol: Introduction
 
 

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The North Central Cancer Treatment Group (NCCTG) has considerable experience with the development of clinical trials to evaluate means for alleviating hot flashes in women. The primary driver for this work is that hot flashes can be a major symptomatic problem in women at risk for, or with a history of, breast cancer. Estrogen therapy, which generally works quite well to alleviate hot flashes, is relatively contraindicated in such women. Starting back in the late 1990s, the Mayo Clinic and the NCCTG have developed and conducted a series of clinical trials evaluating new methods to alleviate hot flashes. These trials are summarized in Table 1.

 

Mayo/NCCTG Hot Flash Studies
Study Description
Patients
Clonidine vs. placebo 4, 5
186
Megestrol acetate vs placebo3
163
Vitamin E vs placebo6
120
Venlafaxine pilot study7
50
Phytoestrogen vs. placebo1
180
Venlafaxine dose-response vs. placebo8
229
Fluoxetine vs. placebo9
60+
Total
988+

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