Breast CancerNCT00226967
Stress, Diurnal Cortisol, and Breast Cancer Survival
An observational study of Breast Cancer, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to learn about the effects of stress on hormones, the relationship between these hormones and cancer progression. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Sandostatin
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2002to Dec 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: patients with recurrent or metastatic breast cancer
Who may be able to join
- 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 .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
The purpose of this study is to learn about the effects of stress on hormones, the relationship between these hormones and cancer progression.
Read the 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
- Being tested
- Sandostatin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SandostatinDrug
Also called Octreotide, Octreo
Calculated per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2005 (estimated)
- Study start8 Sep 2002
- Primary completionNov 2004
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- David Spiegel, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226967
- Sponsor's protocol ID
- IRB-12273
- Other IDs
- 76389, BRSADJ0006
- Status last verified
- Feb 2019
- First submitted
- 13 Sep 2005
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress, Diurnal Cortisol, and Breast Cancer Survival
- ClinicalTrials.gov ID
- NCT00226967
- Acronym / sponsor ID
- IRB-12273
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 8 Sep 2002 (actual)
- Primary completion
- Nov 2004 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 27 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with recurrent or metastatic breast cancer
Key inclusion criteria (5 listed)
- 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 .
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SandostatinAlso: Octreotide, OctreoCalculated per patient | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Spiegel principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.