NCT00228943

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Jul 2005

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 29, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
1 month until next milestone

Results Posted

Study results publicly available

December 10, 2008

Completed
Last Updated

April 14, 2015

Status Verified

March 1, 2015

Enrollment Period

2.3 years

First QC Date

September 14, 2005

Results QC Date

November 13, 2008

Last Update Submit

March 24, 2015

Conditions

Breast Cancer

Keywords

Breast cancer survivorshipHot FlashesSerotonin

Outcome Measures

Primary Outcomes (2)

  • Serum Tryptophan Levels

    Mean serum tryptophan levels (blood draw) at the end of the nadir period.

    baseline, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours

  • Objective Subject Hot Flash Frequency

    Mean of the 24 hour monitoring sessions for each patient based on one 24 hour monitoring session after each intervention using an electronic monitor.

    One 24 hour monitoring session per week for 8 weeks

Study Arms (2)

Acute tryptophan depletion

EXPERIMENTAL

Full-strength tryptophan depletion

Dietary Supplement: Acute tryptophan depletion

Control

ACTIVE COMPARATOR

Half-strength tryptophan depletion drink used as a control

Dietary Supplement: Half-strength tryptophan depletion (Control)

Interventions

Acute tryptophan depletionDIETARY_SUPPLEMENT

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)

Acute tryptophan depletion
Half-strength tryptophan depletion (Control)DIETARY_SUPPLEMENT

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).

Control

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

  • Carpenter 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: 19265726RESULT

MeSH Terms

Conditions

Breast NeoplasmsHot Flashes

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Janet S. Carpenter
Organization
Indiana University
carpentj@iupui.edu
317-278-6093

Study Officials

  • Janet S Carpenter, PhD

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 29, 2005

Study Start

July 1, 2005

Primary Completion

October 1, 2007

Study Completion

November 1, 2008

Last Updated

April 14, 2015

Results First Posted

December 10, 2008

Record last verified: 2015-03

Locations

US(1)