N/A N=28 Randomized Double-blind Basic Science

The Role of Serotonin in Hot Flashes After Breast Cancer

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00228943 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Dec 2008

Primary outcome: Primary: Serum Tryptophan Levels — 0.0034; 0.02 nmol/ml

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Acute tryptophan depletion (Dietary_supplement); Half-strength tryptophan depletion (Control) (Dietary_supplement)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Indiana University
Primary completion: Oct 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Serum Tryptophan Levels	0.0034; 0.02	—
PRIMARY Objective Subject Hot Flash Frequency	2.30; 2.62	—

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.

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.

View full record on ClinicalTrials.gov →

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.