Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Stress, Diurnal Cortisol, and Breast Cancer Survival

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by Stanford University.
Recruitment status was:  Active, not recruiting
Sponsor:
Collaborator:
National Institute on Aging (NIA)
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   (Adult, Senior)
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
National Institute on Aging (NIA)
Investigators
Principal Investigator: David Spiegel Stanford University
  More Information

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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Octreotide
Hydrocortisone
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on December 06, 2016