Sleep, Circadian Hormonal Dysregulation, and Breast Cancer Survival
Ključne besede
Povzetek
Datumi
| Nazadnje preverjeno: | 09/30/2017 |
| Prvič predloženo: | 08/19/2007 |
| Predviden vpis oddan: | 08/19/2007 |
| Prvič objavljeno: | 08/21/2007 |
| Zadnja posodobitev oddana: | 10/03/2017 |
| Zadnja posodobitev objavljena: | 10/05/2017 |
| Dejanski datum začetka študija: | 08/31/2006 |
| Predvideni datum primarnega zaključka: | 08/30/2011 |
| Predvideni datum zaključka študije: | 08/30/2011 |
Stanje ali bolezen
Intervencija / zdravljenje
Procedure: Urine sample
Device: Electrode sleep recorder
Procedure: phlebotomy
Faza
Merila upravičenosti
| Starost, primerna za študij | 45 Years Za 45 Years |
| Spol, upravičen do študija | Female |
| Metoda vzorčenja | Non-Probability Sample |
| Sprejema zdrave prostovoljce | Da |
| Merila | 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) |
