Minocycline Hydrochloride in Reducing Chemotherapy Induced Depression and Anxiety in Patients With Stage I-III Breast Cancer
NCT ID: NCT02203552
Last Updated: 2025-01-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
56 participants
INTERVENTIONAL
2015-06-23
2020-06-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Arm I (minocycline hydrochloride)
Beginning 1 week prior to chemotherapy, patients receive minocycline hydrochloride orally PO BID for 9 weeks. Laboratory biomarker analysis will also be obtained weekly on protocol. Questionnaire administration weekly.
minocycline hydrochloride
100 mg bid given by mouth for 9 weeks
laboratory biomarker analysis
Correlative blood levels for cortisol, high sensitivity c-reactive protein (hs-CRP) and inflammatory factors including but not limited to IL-6, TNF-α, IL-1β, and MCP-1 will also be obtained weekly on protocol.
Questionnaire administration
The CES-D and STAI will be administrated weekly.
Arm II (placebo)
Beginning 1 week prior to chemotherapy, patients receive placebo PO BID for 9 weeks. Laboratory biomarker analysis will also be obtained weekly on protocol. Questionnaire administration weekly.
placebo
Placebo given by mouth for 9 weeks
laboratory biomarker analysis
Correlative blood levels for cortisol, high sensitivity c-reactive protein (hs-CRP) and inflammatory factors including but not limited to IL-6, TNF-α, IL-1β, and MCP-1 will also be obtained weekly on protocol.
Questionnaire administration
The CES-D and STAI will be administrated weekly.
Interventions
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minocycline hydrochloride
100 mg bid given by mouth for 9 weeks
placebo
Placebo given by mouth for 9 weeks
laboratory biomarker analysis
Correlative blood levels for cortisol, high sensitivity c-reactive protein (hs-CRP) and inflammatory factors including but not limited to IL-6, TNF-α, IL-1β, and MCP-1 will also be obtained weekly on protocol.
Questionnaire administration
The CES-D and STAI will be administrated weekly.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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)
18 Years
FEMALE
No
Sponsors
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Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Bhuvaneswari Ramaswamy, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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The Jamesline
Other Identifiers
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NCI-2014-00851
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-13165
Identifier Type: -
Identifier Source: org_study_id
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