N/A
Completed N=28
The Role of Serotonin in Hot Flashes After Breast Cancer
Source: ClinicalTrials.gov NCT00228943 ↗Enrolled (actual)
28
Serious AEs
—
Results posted
Dec 2008
Primary outcomePrimary: Serum Tryptophan Levels — 0.0034; 0.02 nmol/ml
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 involved in the induction of hot flashes in women with breast cancer and genetic variations in the serotonin receptors and transporters also play a role.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Tryptophan Levels |
0.0034; 0.02 | — |
| PRIMARY Objective Subject Hot Flash Frequency |
2.30; 2.62 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00228943). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.