Phase II Study of Curcumin vs Placebo for Chemotherapy-Treated Breast Cancer Patients Undergoing Radiotherapy
Completed · Phase 2 · Has a placebo group
Conditions studied: Breast Cancer
In brief
The main purpose of the investigation is to determine if curcumin reduces NF-kB DNA binding and ultimately its downstream mediator IL-6 in patients receiving XRT for their breast cancer after having completed chemotherapy. Patients who have received prior chemotherapy will be eligible, because we have found that this enriched population is at particular risk for exhibiting increased NF-kB DNA binding and IL-6 following XRT.
Key facts
- Study ID
- NCT01740323
- Run by
- Andrew H Miller
- People needed
- 30
- Starts
- 2015-05-01
- Expected to finish
- 2018-07-27
- Last updated by the study team
- 2019-09-18
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Female breast cancer patients over the age of 18 will be recruited for this study. Patients enrolled in the study will meet standard criteria for whole breast XRT.
You may not qualify if…
- Subjects will be excluded for a number of medical conditions that are contraindications to XRT and/or might confound the relationship among fatigue, and inflammation, including pregnancy, major psychiatric disorders, autoimmune or inflammatory disorders, chronic infectious diseases (e.g. HIV, hepatitis B or C), neurologic disorders and uncontrolled cardiovascular, metabolic, pulmonary or renal disease (as determined by medical history, physical examination and laboratory testing). Subjects with a history of a major psychiatric disorder including Schizophrenia or Bipolar Disorder or a diagnosis of Substance Abuse or Dependence within the past 1 year (as determined by standardized psychiatric interview) will be excluded. Subjects taking drugs known to affect the immune system (e.g. glucocorticoids, methotrexate) will also be excluded. Subjects using supplements or other natural products with one week of starting medications, excluding vitamins and calcium supplementation or at the discretion of the attending physician, will be excluded. Patients who have evidence of infection as determined by history, physical exam or laboratory testing (complete blood count and urinalysis) at baseline will be excluded. In addition, patients who develop evidence of infection (as determined by history, physical exam or laboratory testing) during the study will be discontinued from the study.
Where it is running
- Emory University — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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