Stress, Diurnal Cortisol, and Breast Cancer Survival

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00226967
First received: September 13, 2005
Last updated: November 9, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention
Breast Cancer
Drug: Sandostatin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Stress, Diurnal Cortisol, and Breast Cancer Survival

Resource links provided by NLM:


Further study details as provided by Stanford University:

Biospecimen Retention:   Samples Without DNA

Saliva


Estimated Enrollment: 115
Study Start Date: September 2002
Estimated Study Completion Date: December 2012
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Sandostatin
    Calculated per patient
    Other Names:
    • Octreotide
    • Octreo
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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00226967

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: David Spiegel Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00226967     History of Changes
Other Study ID Numbers: BRSADJ0006, 76389, BRSADJ0006, 12273
Study First Received: September 13, 2005
Last Updated: November 9, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 21, 2014