Overview

Phase II Study of Curcumin vs Placebo for Chemotherapy-Treated Breast Cancer Patients Undergoing Radiotherapy

Status:
Completed
Trial end date:
2018-07-27
Target enrollment:
0
Participant gender:
Female
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Andrew H Miller
Collaborator:
National Cancer Institute (NCI)
Treatments:
Curcumin
Criteria
Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.