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Sleep, Circadian, Hormonal Dysregulation, and Breast Cancer Survival


N/A
45 Years
75 Years
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

Sleep, Circadian, Hormonal Dysregulation, and Breast Cancer Survival


Inclusion Criteria:



Inclusion criteria for women with breast cancer:

1. Female

2. Between 45 and 75 years old (45<=>75)

3. Documented metastatic or recurrent breast cancer

4. Karnofsky rating of at least 70% (measure of physical ability used to assess
medically ill patients)

5. Residence within the Greater San Francisco Bay Area

6. Proficiency in English sufficient to complete questionnaires

7. Postmenopausal

8. Non smoker (occasional smoking will be ok, they need to agree to stop smoking during
study participation. If smoking cessation will cause withdrawal, they can not
participate)

9. Willing to go through a 30 day washout period if they are currently on Decadron or
any other corticosteroids (depending on the dose, may be able to reduce 30 days to 2
weeks)

10. If taking Benzodiazepines, willing to stop 3 days before the collection of
physiological measures, such as the 2 week at home sleep recordings and then the 3
days before and during the GCRC (if not possible, washout period may be reduced to 3
days before and during the CTRU/GCRC stay)

11. Willingness to discontinue taking melatonin one week before the CTRU/GCRC stay

12. Willingness to discontinue any current sleeping medications 3 days before 2 week at
home sleep data collection through the end of study participation (if not possible,
washout period may be reduced to 3 days before and during the CTRU/GCRC stay)

13. Willingness to abstain from traveling 2 or more time zones away from California
(Pacific time), two weeks before and during participation in the study

14. Willing/able to refrain from doing shift-work in a non-traditional schedule (such as
4pm to midnight or 10pm to 6am) starting two weeks before at home sleep collection
through the end of study participation.

15. Agree to catheterization for blood sample collection

16. Agrees with the use of heparin during the blood draws (used to keep IV line from
clotting)

17. Has graduated high school or obtained GED

18. US Citizen or resident viable for payment, legally

Inclusion criteria for healthy controls:

1. Female

2. Between 45 and 75 years old (45<=>75)

3. No history of any type of cancer

4. Residence within the Greater San Francisco Bay Area

5. Proficiency in English to complete questionnaires

6. Post Menopausal

7. Non-smoker (occasional smoking will be ok, they need to agree to stop smoking during
study participation. If smoking cessation will cause withdrawal, they can not
participate)

8. If taking benzodiazepines, willing to stop 3 days before the collection of
physiological measures, such as the 2 week at home sleep recordings and then the 3
days before and during the GCRC (if not possible, washout period may be reduced to 3
days before and during the CTRU/GCRC stay)

9. Willingness to discontinue taking melatonin one week before the CTRU/GCRC stay

10. Willingness to discontinue any current sleeping medications 3 days before 2 week at
home sleep data collection through the end of study participation (if not possible,
washout period may be reduced to 3 days before and during the CTRU/GCRC stay)

11. Willingness to abstain from traveling 2 or more time zones away from California
(Pacific time), two weeks before and during participation in the study

12. Willing/able to refrain from doing shift-work in a non-traditional schedule (such as
4pm to midnight or 10pm to 6am) starting two weeks before at home sleep collection
through the end of study participation

13. Agree to catheterization for blood sample collection

14. Agrees with the use of heparin during the blood draws (used to keep IV line from
clotting)

15. Has graduated high school or obtained GED

16. US Citizen or resident viable for payment, legally

17. Pittsburgh Sleep Quality Index (PSQI) score >6

Exclusion Criteria:Exclusion criteria for women with breast cancer:

1. Other 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

2. Concurrent medical condition likely to influence short term survival (such as liver
disease, asthma etc, depending on severity)

3. History of major psychiatric illness that required hospitalization or medication

4. Substance Dependence or abuse

5. Low hematocrit (up to the digression of the PI, may be able to participate in parts
of the protocol)

6. Bilateral lymph nodes removed

7. Diagnosis of diabetes (need to check with PI, some mild cases of diabetes may be ok)

8. Positive supraclavicular lymph nodes as the only metastatic lesion at the time of
initial diagnosis

9. PICC line too close to the few available veins, viable for catheterization (too high
of a risk for infection/complication), and is on the only arm which did not have
lymph node surgery

Exclusion criteria for healthy controls:

1. Concurrent medical condition likely to influence short term survival (such as liver
disease, asthma etc, depending on severity)

2. History of major psychiatric illness that required hospitalization or medication

3. Substance dependence or abuse

4. Low hematocrit (up to the digression of the PI, may be able to participate in parts
of the protocol)

5. Diagnosis of diabetes (need to check with PI, some mild cases of diabetes may be ok)

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Principal Investigator

David Spiegel

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Food and Drug Administration

Study ID:

BRSADJ0013

NCT ID:

NCT00519168

Start Date:

September 2006

Completion Date:

August 2017

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

Stanford University School of MedicineStanford, California  94305-5317