Clinical trial NCT02203552: Minocycline Hydrochloride in Reducing Chemotherapy Induced Depression and Anxiety in Patients With Stage I-III Breast Cancer
Official title: Randomized Placebo Controlled Study of Minocycline for Amelioration of Chemotherapy Induced Affective Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Keywords: Breast Cancer
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2014-07-30
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 hydrochloride may prevent changes in memory and thinking and improve the quality of life of breast cancer patients receiving chemotherapy.

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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)

Primary outcomes:
measure: Changes in Center for Epidemiological Studies Depression Scale (CES-D) Scores
timeFrame: Baseline to 9 weeks
measure: Changes in the State Trait Anxiety Index (STAI) Scores
timeFrame: Baseline to 9 weeks
Secondary outcomes:
measure: Changes in Hamilton Anxiety Rating Scale Scores
timeFrame: Baseline to 9 weeks
measure: Changes in Hamilton Rating Scale for Depression Scores
timeFrame: Baseline to 9 weeks
measure: Changes in Inflammatory Blood Markers
timeFrame: Baseline to 6 months
measure: Changes in the PET/MRI Measures
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Bhuvaneswari Ramaswamy, MD
role: PRINCIPAL_INVESTIGATOR
References: