Phase 2
Completed N=30
Phase II Study of Curcumin vs Placebo for Chemotherapy-Treated Breast Cancer Patients Undergoing Radiotherapy
Source: ClinicalTrials.gov NCT01740323 ↗Enrolled (actual)
30
Serious AEs
6.7%
Results posted
Sep 2019
Primary outcomePrimary: PBMC NF-kB DNA Binding Measured in ng/Well — 9.01; 9.56; 17.54; 16.04 ng/well
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PBMC NF-kB DNA Binding Measured in ng/Well |
9.01; 9.56; 17.54; 16.04 | — |
| PRIMARY Plasma TNF-alpha |
5.87; 4.93; 4.93; 5.24 | — |
| PRIMARY Plasma sTNFR2 Measured in pg/ml |
— | — |
| PRIMARY Plasma IL-1ra Measured in pg/ml |
— | — |
| PRIMARY Plasma IL-6 Measured in pg/ml |
2.29; 1.84; 2.04; 1.77 | — |
| PRIMARY Plasma C-reactive Protein (CRP) Measured in mg/L |
2.71; 2.72; 3.85; 2.30 | — |
| SECONDARY Fatigue |
56.69; 57.40; 50.23; 46.67 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01740323). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.