This randomized phase II trial studies how well curcumin works in reducing fatigue in patients with chemotherapy-treated breast cancer undergoing radiotherapy. Patients treated with chemotherapy and radiotherapy are known to have a heightened inflammatory and immune response that may lead to feelings of fatigue. The nuclear factor kappa-B (NF-kB) pathway has emerged as having an important role not only in cancer treatment resistance but in the development of fatigue. Curcumin may reduce symptoms of fatigue by decreasing NF-kB activation. Studying samples of blood from patients with breast cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify possible mechanisms related to the development of fatigue.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01740323.
PRIMARY OBJECTIVES:
I. To determine if curcumin (Meriva) reduces NF-kB deoxyribonucleic acid (DNA)-binding and its downstream mediators in patients receiving radiation therapy (XRT) for their breast cancer after having completed chemotherapy.
SECONDARY OBJECTIVES:
I. Determine if Meriva decreases levels of fatigue as measured by the Multidimensional Fatigue Inventory (MFI) in breast cancer (BRCA) patients.
II. To determine longitudinal variances in skin changes measured by ultrasound in breast cancer patients undergoing XRT.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive curcumin orally (PO) twice daily (BID) for approximately 6 weeks beginning immediately after the completion of XRT or up to 3 months post- XRT.
ARM II: Patients receive placebo PO BID for approximately 6 weeks beginning immediately after the completion of XRT or up to 3 months post- XRT.
After completion of study, patients are followed up at 6 weeks.
Lead OrganizationEmory University Hospital/Winship Cancer Institute
Principal InvestigatorAndrew Hebb Miller