This randomized phase II trial studies how well minocycline hydrochloride works in reducing chemotherapy induced depression and anxiety in patients with stage I-III breast cancer. Minocycline hydrochloride may prevent changes in memory and thinking and improve the quality of life of breast cancer patients receiving chemotherapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02203552.
PRIMARY OBJECTIVES:
I. To evaluate symptoms related to anxiety and depression and cognitive changes in women with stages I-III breast cancer during doxorubicin-based or other chemotherapy regimens for breast cancer randomized to receive either minocycline (minocycline hydrochloride) or placebo.
II. To evaluate markers of neuroinflammation as assessed by blood based inflammatory cytokines and C11-choline positron emission tomography (PET) in women with stages I-III breast cancer during doxorubicin-based or other chemotherapy regimens for breast cancer randomized to receive either minocycline or placebo.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Beginning 1 week prior to chemotherapy, patients receive minocycline hydrochloride orally (PO) twice daily (BID) for 6 months.
ARM II: Beginning 1 week prior to chemotherapy, patients receive placebo PO BID for 6 months.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationOhio State University Comprehensive Cancer Center
Principal InvestigatorBhuvaneswari Ramaswamy