Stress, Diurnal Cortisol, and Breast Cancer Survival

NCT ID: NCT00226967

Last Updated: 2020-01-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 115 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2002-09-08
• Study Completion Date: 2005-12-31

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.

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Sandostatin

Calculated per patient

Intervention Type: DRUG

Other Intervention Names

Octreotide; Octreo

Eligibility 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.

• Minimum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Spiegel

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

76389

Identifier Type: OTHER

Identifier Source: secondary_id

BRSADJ0006

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-12273

Identifier Type: -

Identifier Source: org_study_id