Status:
COMPLETED
The Role of Serotonin in Hot Flashes After Breast Cancer
Lead Sponsor:
Indiana University School of Medicine
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this proposal is to improve our understanding of the role of tryptophan and serotonin in hot flashes. The main hypothesis is that alterations in tryptophan and serotonin levels are invo...
Detailed Description
Among women with breast cancer, hot flashes are a frequent, severe and bothersome symptom. For this group, hot flashes are negatively related to mood, affect, and daily activities and can compromise c...
Eligibility Criteria
Inclusion
- At least 18 years of age
- Willing and able to provide informed consent
- Reporting daily hot flashes
- Able to read, write, and speak English
- Postmenopausal to limit sample variability (\> 12 months amenorrhea)
- Greater then 1 month but \< 5 years post-treatment (surgery, radiation, chemotherapy) for non-metastatic breast cancer.
- These criteria allow inclusion of women successfully treated for recurrent breast cancer since there is no known reason to exclude them. Menopausal status is assessed using self-reports due to problems in reliably measuring follicle-stimulating hormone levels and estradiol in tamoxifen users.
Exclusion
- Exclusion criteria are current depression, history of migraines or hepatitis, abnormal chemistry profile (e.g., sodium, potassium, glucose), or a positive urine drug screen for illegal substances.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00228943
Start Date
July 1 2005
End Date
November 1 2008
Last Update
April 14 2015
Active Locations (1)
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1
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202