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Stress, Diurnal Cortisol, and Breast Cancer Survival

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ClinicalTrials.gov Identifier: NCT00226967
Recruitment Status : Unknown
Verified November 2012 by Stanford University.
Recruitment status was:  Active, not recruiting
First Posted : September 27, 2005
Last Update Posted : November 14, 2012
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Stanford University

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.

Condition or disease Intervention/treatment
Breast Cancer Drug: Sandostatin

Detailed Description:
The purpose of this study is to investigate stress and tonic activation of diurnal cortisol in aging metastatic breast cancer patients; feedback inhibition & activation of cortisol; and stress-induced phasic activation of cortisol.

Study Type : Observational
Estimated Enrollment : 115 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Stress, Diurnal Cortisol, and Breast Cancer Survival
Study Start Date : September 2002
Actual Primary Completion Date : November 2004
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources


Intervention Details:
    Drug: Sandostatin
    Calculated per patient
    Other Names:
    • Octreotide
    • Octreo


Biospecimen Retention:   Samples Without DNA
Saliva


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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with recurrent or metastatic breast cancer
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Positive supraclavicular lymph nodes as the only metastatic lesion at the time of initial diagnosis.
  2. 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.
  3. Any other serious medical condition that will effect short term survival
  4. History of major psychiatric illness for which patient was hospitalized or medicated, with the exception of depression or anxiety
  5. A diagnosis of diabetes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00226967


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Institute on Aging (NIA)
Investigators
Principal Investigator: David Spiegel Stanford University

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00226967     History of Changes
Other Study ID Numbers: BRSADJ0006
76389 ( Other Identifier: Stanford University Alternate IRB Approval Number )
BRSADJ0006 ( Other Identifier: Stanford University )
12273 ( Other Identifier: Stanford IRB )
First Posted: September 27, 2005    Key Record Dates
Last Update Posted: November 14, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hydrocortisone
Octreotide
Anti-Inflammatory Agents
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents