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Hot Flashes Study Sections
 Author Bio
Introduction 
Commentator Bio
Protocol Schema
Protocol Background
Protocol Goals
Currently selected section: 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: Patient Eligibility
 

3.1 Required characteristics Microphone Image

3.11 Female age =18 years.

3.12 History of breast cancer (history of dcis or lcis acceptable; currently without malignant disease); TAM and raloxifene are allowed if started =4 weeks prior to registration and the plan is to continue throughout the study.

3.13 Bothersome hot flashes (defined by their occurrence at least 14 times per week and of sufficient severity to make the patient desire therapeutic intervention).

3.14 Presence of hot flashes for at least one month prior to study entry.

3.15 Life expectancy =6 months. 3.16 ECOG PS 0-1.

3.2 Contraindications Microphone Image

3.21 Any of the following current (=4 weeks) or planned therapies:

  • Antineoplastic chemotherapy;
  • Androgens;
  • Estrogens;
  • Progestational agents, and
  • Corticosteroids.
3.22 History of allergic reaction to soy products.

3.23 Regular use (more than once per week) of phytoestrogen pills, soy milk or soy products such as tofu. However, the patient would be eligible if these products are stopped for seven days prior to registration.

3.24 Current or planned use of other agents for treating hot flashes (megestrol acetate, clonidine, Bellergal-s, vitamin E, etc.).


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