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Skin Conduction Device for Measuring Hot Flashes in Postmenopausal Women With Hot Flashes

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00427622
First received: January 25, 2007
Last updated: November 21, 2009
Last verified: June 2007
History of Changes

January 25, 2007
November 21, 2009
May 2006
Not Provided
  • Correlation of hot flash frequency, as measured by an ambulatory sternal skin conductance measuring and recording tool, with patient-recorded hot flash frequency using a hot flash diary [ Designated as safety issue: No ]
  • Comfort, obtrusiveness, and feasibility of using the skin conductance recording tool [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00427622 on ClinicalTrials.gov Archive Site
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Skin Conduction Device for Measuring Hot Flashes in Postmenopausal Women With Hot Flashes
A Trial to Examine the Accuracy of an Ambulatory Sternal Skin Conductance Recording Tool to Measure Hot Flashes

RATIONALE: Measuring how often hot flashes occur in postmenopausal women may be done by using a skin conduction device or by using a diary.

PURPOSE: This clinical trial is comparing a skin conduction device with a hot flash diary as a way of measuring hot flashes in postmenopausal women with hot flashes.

OBJECTIVES:

  • Correlate hot flash frequency, as measured by an ambulatory sternal skin conductance measuring and recording tool, with patient-recorded hot flash frequency using a hot flash diary in postmenopausal women with hot flashes.
  • Determine the comfort, obtrusiveness, and feasibility of using the skin conductance recording tool for measuring hot flashes when worn daily for five weeks in these patients.

OUTLINE: Patients wear an ambulatory sternal skin conductance hot flash device continuously for 5 weeks.

Patients complete hot flash diaries once daily for 5 weeks. Patients also complete the Comfort, Bother, and Weight Questionnaire at the end of week 5.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Interventional
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Masking: Open Label
Primary Purpose: Diagnostic
Hot Flashes
Other: physiologic testing
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
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DISEASE CHARACTERISTICS:

  • Diagnosis of bothersome hot flashes, defined by their occurrence of ≥ 4 times/day

    • Daily hot flashes have been present for ≥ 1 month

PATIENT CHARACTERISTICS:

  • Female
  • Postmenopausal
  • ECOG performance status 0-1
  • No history of allergic or other adverse reactions to adhesives
  • No other medical condition known to cause sweating and/or flushing
  • Willing to record hot flashes in a hot flash diary daily for 5 weeks
  • Willing to wear a skin conductance device 24 hours a day for 5 weeks
  • No implanted pacemakers or metal implants
  • No reliance on other electronic devices for regular monitoring (i.e., insulin pumps or blood pressure monitors)

PRIOR CONCURRENT THERAPY:

  • Not specified
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00427622
CDR0000526174, MAYO-MC05CC
Not Provided
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Mayo Clinic
National Cancer Institute (NCI)
Study Chair: Debra Barton, RN, PhD, AOCN, FAAN Mayo Clinic
Investigator: Charles L. Loprinzi, MD Mayo Clinic
Investigator: Ann E. Kearns, MD Mayo Clinic
Investigator: Gary Harvey Advanced Medical Electronics
National Cancer Institute (NCI)
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP