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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
  Purpose

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.


Condition Intervention
Hot Flashes
 Other: physiologic testing

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Trial to Examine the Accuracy of an Ambulatory Sternal Skin Conductance Recording Tool to Measure Hot Flashes

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 25
Study Start Date: May 2006
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00427622

Locations
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
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
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00427622     History of Changes
Other Study ID Numbers: CDR0000526174, MAYO-MC05CC
Study First Received: January 25, 2007
Last Updated: November 21, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
hot flashes

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013