NCT00226967

Brief Summary

The purpose of this study is to learn about the effects of stress on hormones, the relationship between these hormones and cancer progression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2002

Typical duration for all trials

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

September 8, 2002

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 27, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

January 27, 2020

Status Verified

February 1, 2019

Enrollment Period

2.2 years

First QC Date

September 13, 2005

Last Update Submit

January 23, 2020

Conditions

Breast Cancer

Interventions

SandostatinDRUG

Calculated per patient

Also known as: Octreotide, Octreo

Eligibility Criteria

Age35 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with recurrent or metastatic breast cancer

You may qualify if:

  • Diagnosis of recurrent or metastatic breast cancer.
  • Karnofsky of 70% or greater.
  • Proficient enough in English to be able to take questionnaires and participate in the required tasks.
  • Living within the Greater Bay Area.
  • Age 35 or older .

You may not qualify if:

  • Positive supraclavicular lymph nodes as the only metastatic lesion at the time of initial diagnosis.
  • Active cancers within the past 10 years other than breast cancer, basal cell or squamous cell carcinomas of the skin, or in situ cancer of the cervix.
  • Any other serious medical condition that will effect short term survival
  • History of major psychiatric illness for which patient was hospitalized or medicated, with the exception of depression or anxiety
  • A diagnosis of diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Octreotide

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • David Spiegel

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 27, 2005

Study Start

September 8, 2002

Primary Completion

November 1, 2004

Study Completion

December 1, 2005

Last Updated

January 27, 2020

Record last verified: 2019-02

Locations

US(1)