Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT00096356
Eligibility Criteria:
Inclusion Criteria:
* Signed consent
* Hg \> 11g/dl; supportive measures (erythropoietin, transfusion, iron therapy) should be utilized to assist with maintaining Hgb levels
* Total cholesterol \> 160mg/dL.
* Female with primary cancer diagnosis (breast)
* Planned adjuvant chemotherapy (neoadjuvant chemotherapy is excluded)
* KPS \> 60
* Bilirubin \< 1.5 x ULN
* SGOT \< 2.5 x ULN
* SGPT \< 2.5 x ULN
Exclusion Criteria:
* Recent involuntary weight loss (\> 5% of body weight in the past 3 months)
* Statin therapy - current or planned during study. Below is a list of some commonly used statin drugs.(Note: This is a helpful guide, not a complete list.)
* Atorvastatin (Lipitor)
* Cerivastatin
* Fluvastatin (Lescol)
* Lovastatin (Mevacor, Altocor, Advicor)
* Mevastatin
* Pravastatin (Pravachol)
* Rosuvastatin
* Simvastatin (Zocor)
* Current or planned use of the following medications for fatigue
* Corticosteroids (intermittent use as part of chemotherapy regimen is allowed)
* Amphetamines or other stimulants including methylphenidate (Ritalin)or modafinil (Provigil)
* Patients diagnosed with uncontrolled hypertension
* Breast cancer patients who are male
* Pregnant women are excluded from participation in this study. A Serum pregnancy test is required within 1 week of registration if the patient is a woman of childbearing potential.
* Anticoagulant therapy - current or planned during study (except for maintenance of catheter patency)
* Patients with uncontrolled thyroid dysfunction
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00096356
Study Brief:
Protocol Section:
NCT00096356