Status:
COMPLETED
Minocycline Hydrochloride in Reducing Chemotherapy Induced Depression and Anxiety in Patients With Stage I-III Breast Cancer
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Conditions:
Anxiety Disorder
Depression
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This randomized clinical trial studies how well minocycline hydrochloride works in reducing chemotherapy induced depression and anxiety in patients with stage I-III breast cancer. Minocycline hydrochl...
Detailed 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 minocycl...
Eligibility Criteria
Inclusion
- Women diagnosed with breast cancer stages I-III initiating first line adjuvant or neoadjuvant doxorubicin hydrochloride (DOX) chemotherapy
- Postmenopausal defined as amenorrhea \> 12 months or follicle stimulating hormone (FSH) and estradiol in institutional postmenopausal range
- Ability to understand English and read and write at the 8th grade level and give a written informed consent document
- For additional cohort, women with breast cancer stages I-III who currently on or within 18 months of completing first line adjuvant or neoadjuvant DOX chemotherapy or other chemotherapy for breast cancer.
Exclusion
- Rheumatoid arthritis and other types of autoimmune and inflammatory joint disease, with the exception of osteoarthritis and fibromyalgia
- Concurrent other malignancy or metastatic malignancy of any kind
- Reported diagnosis of major depression or anxiety disorder prior to breast cancer (BC) diagnosis
- Currently prescribed psychotropic medications including anti-depressants
- Known bleeding disorders
- History of diabetes mellitus, heart disease or stroke
- Current use of warfarin or other anticoagulants
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, hypertension, or psychiatric illness/social situation that would limit compliance with study requirements
- Pregnant or nursing women
- Concurrent use of daily full dose aspirin (\>= 325 mg/day), nonsteroidal anti-inflammatory drugs (NSAIDs) or NSAID-containing products or steroids; one month washout period is required prior to randomization
- Unable to give informed consent
- Tetracycline allergy
- Any contraindication to magnetic resonance imaging (MRI)/PET examination including but not limited to ferromagnetic metal in the body, pacemaker, or severe claustrophobia; (however, this portion is optional and if patient is otherwise eligible, can enroll in study without participating in imaging study)
Key Trial Info
Start Date :
June 23 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2020
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT02203552
Start Date
June 23 2015
End Date
June 15 2020
Last Update
January 8 2025
Active Locations (1)
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1
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210