Clinical trial · Interventional
The Role of Serotonin in Hot Flashes After Breast Cancer
NCT00228943CI-TRIAL-00017490completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acute tryptophan depletion | Dietary Supplement | — | UNRESOLVED |
| Half-strength tryptophan depletion (Control) | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Acute tryptophan depletion
- description
- Full-strength tryptophan depletion
- interventionNames
- Dietary Supplement: Acute tryptophan depletion
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- Half-strength tryptophan depletion drink used as a control
- interventionNames
- Dietary Supplement: Half-strength tryptophan depletion (Control)
Primary outcomes (2)
- measure
- Serum Tryptophan Levels
- timeFrame
- baseline, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTCarpenter JS, Yu M, Wu J, Von Ah D, Milata J, Otte JL, Johns S, Schneider B, Storniolo AM, Salomon R, Desta Z, Cao D, Jin Y, Philips S, Skaar TC. Evaluating the role of serotonin in hot flashes after breast cancer using acute tryptophan depletion. Menopause. 2009 Jul-Aug;16(4):644-52. doi: 10.1097/gme.0b013e318199e9f6. PMID 19265726