CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28 enrolled
Drug / intervention
Acute tryptophan depletion +1 moredietary
Likely dose
Acute tryptophan depletion: L-alanine (5.5g), L-arginine (4.9g), L-cysteine (2.7g), glycine (3.2g), L-histidine (3.2g), L-isoleucine (8.0g), L-leucine (13.5g), L-lysine (11.0g), L-methionine (3.0g), L-phenylalanine (5.7g), L-proline (12.2g), L-serine (6.9g), L-threonine (6.9g), L-tyrosine (6.9g), L-valine (8.9g)AI-extracted
Key inclusion· 5
  • At least 18 years of age
  • Reporting daily hot flashes
  • Postmenopausal (>12 months amenorrhea) to limit sample variability
  • 1 month to 5 years post-treatment (surgery, radiation, chemotherapy) for non-metastatic breast cancer
Key exclusion· 5
  • Current depression
  • History of migraines
  • History of hepatitis
  • Abnormal chemistry profile (e.g., sodium, potassium, glucose)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00228943
NCT00228943N/ACompleted

The Role of Serotonin in Hot Flashes After Breast Cancer

Indiana University·interventional·Posted Sep 29, 2005·Updated Apr 14, 2015

In Brief

A clinical study evaluating Acute tryptophan depletion and Half-strength tryptophan depletion (Control) for Breast Cancer. Completed, enrolled 28 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 29, 2005
Enrollment StartJul 1, 2005
Primary CompletionOct 1, 2007
Study CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 20.8 years ago

Interventions

Acute tryptophan depletiondietary

L-alanine (5.5g), L-arginine (4.9g), L-cysteine (2.7g), glycine (3.2g), L-histidine (3.2g), L-isoleucine (8.0g), L-leucine (13.5g), L-lysine (11.0g), L-methionine (3.0g), L-phenylalanine (5.7g), L-proline (12.2g), L-serine (6.9g), L-threonine (6.9g), L-tyrosine (6.9g), L-valine (8.9g)

Half-strength tryptophan depletion (Control)dietary

L-alanine (1.4g), L-arginine (1.2g), L-cysteine (0.7g), glycine (0.8g), L-histidine (0.8g), L-isoleucine (2.0g), L-leucine (3.4g), L-lysine (2.8g), L-methionine (0.8g), L-phenylalanine (1.4g), L-proline (3.1g), L-serine (1.7g), L-threonine (1.7g), L-tyrosine (1.7g), L-valine (2.2g), and fillers (7.95g).