Minocycline Hydrochloride in Reducing Chemotherapy Induced Depression and Anxiety in Patients With Stage I-III Breast Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 36
Summary
- Conditions
- Anxiety Disorder
- Depression
- Recurrent Breast Cancer
- Stage IA Breast Cancer
- Stage IB Breast Cancer
- Stage II Breast Cancer
- Stage IIIA Breast Cancer
- Stage IIIB Breast Cancer
- Stage IIIC Breast Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
PRIMARY OBJECTIVES: I. To evaluate anxiety and depression in women with stages I-III breast cancer during the first 8 weeks of doxorubicin-based adjuvant therapy randomized to receive either minocycline (minocycline hydrochloride) or placebo. II. To evaluate markers of neuro-inflammation as assessed...
PRIMARY OBJECTIVES: I. To evaluate anxiety and depression in women with stages I-III breast cancer during the first 8 weeks of doxorubicin-based adjuvant therapy randomized to receive either minocycline (minocycline hydrochloride) or placebo. II. To evaluate markers of neuro-inflammation as assessed by blood based inflammatory cytokines and C11-choline positron emission tomography (PET) in women with stages I-III breast cancer during the first 8 weeks of doxorubicin-based adjuvant therapy 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 9 weeks. ARM II: Beginning 1 week prior to chemotherapy, patients receive placebo PO BID for 9 weeks. After completion of study treatment, patients are followed up for 6 months.
Tracking Information
- NCT #
- NCT02203552
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Maryam Lustberg, MD Ohio State University Comprehensive Cancer Center
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