Stress, Diurnal Cortisol, and Breast Cancer Survival
This study is ongoing, but not recruiting participants.
Sponsor:
Stanford University
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
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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:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Hydrocortisone acetate
Hydrocortisone
Hydrocortisone sodium succinate
Hydrocortisone cypionate
Hydrocortisone butyrate
Hydrocortisone valerate
Hydrocortisone probutate
Octreotide acetate
Octreotide
U.S. FDA Resources
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:
Detailed Description:
-
Drug: Sandostatin
- Octreotide
- Octreo
Calculated per patient
Other Names:
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:
- 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 .
Exclusion Criteria:
- 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.
Contacts and Locations
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 Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Hydrocortisone Octreotide |
Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 23, 2013