Minocycline Hydrochloride in Reducing Chemotherapy Induced Depression and Anxiety in Patients With Stage I-III Breast Cancer

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Ohio State University Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Maryam Lustberg, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT02203552
First received: July 28, 2014
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
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
Drug: minocycline hydrochloride
Other: placebo
Other: laboratory biomarker analysis
Other: Questionnaire administration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Randomized Placebo Controlled Study of Minocycline for Amelioration of Chemotherapy Induced Affective Disorders

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Changes in Center for Epidemiological Studies Depression Scale (CES-D) scores [ Time Frame: Baseline to 9 weeks ] [ Designated as safety issue: No ]
    The 95% confidence intervals of the depression change from baseline to the end of study and the difference between the treatment and placebo groups. The influences of covariate, such as disease stage and depression drug usage, will be considered in the mixed models as exploratory analyses.

  • Changes in the State Trait Anxiety Index (STAI) scores [ Time Frame: Baseline to 9 weeks ] [ Designated as safety issue: No ]
    The 95% confidence intervals of the anxiety change from baseline to the end of study and the difference between the treatment and placebo groups. The influences of covariate, such as disease stage and depression drug usage, will be considered in the mixed models as exploratory analyses.


Secondary Outcome Measures:
  • Changes in Hamilton Anxiety Rating Scale scores [ Time Frame: Baseline to 9 weeks ] [ Designated as safety issue: No ]
    The 95% confidence intervals of the anxiety change from baseline to the end of study and the difference between the treatment and placebo groups. The influences of covariate, such as disease stage and depression drug usage, will be considered in the mixed models as exploratory analyses. In addition, change overtime of all outcomes for each individual will be plotted to visually explore any patterns and to generate hypothesis to be tested in future studies.

  • Changes in Hamilton Rating Scale for Depression scores [ Time Frame: Baseline to 9 weeks ] [ Designated as safety issue: No ]
    The 95% confidence intervals of the depression change from baseline to the end of study and the difference between the treatment and placebo groups. The influences of covariate, such as disease stage and depression drug usage, will be considered in the mixed models as exploratory analyses. In addition, change overtime of all outcomes for each individual will be plotted to visually explore any patterns and to generate hypothesis to be tested in future studies.

  • Changes in inflammatory blood markers [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    Scatter plots will be used to explore the pair-wise correlation among the changes of CES-D and STAI scores, blood biomarkers changes, and PET/MRI measures. A statistical model will be used to explore whether the blood based biomarkers and PET/MRI measures can be used to predict the changes in CES-D and STAI scores, which then could be used as potential surrogate markers in future studies.

  • Changes in the PET/MRI measures [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    Scatter plots will be used to explore the pair-wise correlation among the changes of CES-D and STAI scores, blood biomarkers changes, and PET/MRI measures. A statistical model will be used to explore whether the blood based biomarkers and PET/MRI measures can be used to predict the changes in CES-D and STAI scores, which then could be used as potential surrogate markers in future studies.


Estimated Enrollment: 36
Study Start Date: September 2014
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: minocycline hydrochloride
100 mg bid given by mouth for 9 weeks
Other Names:
  • Dynacin
  • Minocin
  • Minomax
  • Minomycin
Other: 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.
Other Names:
  • special studies
  • Correlative studies
Other: Questionnaire administration
The CES-D and STAI will be administrated weekly.
Other Name: Ancillary studies
Placebo Comparator: 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.
Other: placebo
Placebo given by mouth for 9 weeks
Other Name: PLCB
Other: 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.
Other Names:
  • special studies
  • Correlative studies
Other: Questionnaire administration
The CES-D and STAI will be administrated weekly.
Other Name: Ancillary studies

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02203552

Contacts
Contact: Ohio State University Comprehensive Cancer Center 1-800-293-5066 Jamesline@osumc.edu
Contact: Maryam Lustberg, MD 614-293-8858 maryam.lustberg@osumc.edu

Locations
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Not yet recruiting
Columbus, Ohio, United States, 43210
Contact: Maryam B. Lustberg, MD    614-293-0066    Maryam.Lustberg@osumc.edu   
Principal Investigator: Maryam B. Lustberg         
Stefanie Spielman Comprehensive Breast Center Not yet recruiting
Columbus, Ohio, United States, 43212
Contact: Maryam B. Lustberg    614-293-0066    Maryam.Lustberg@osumc.edu   
Principal Investigator: Maryam B. Lustberg         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Maryam Lustberg, MD Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Maryam Lustberg, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02203552     History of Changes
Other Study ID Numbers: OSU-13165, NCI-2014-00851
Study First Received: July 28, 2014
Last Updated: August 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
Breast Cancer

Additional relevant MeSH terms:
Depression
Depressive Disorder
Anxiety Disorders
Disease
Breast Neoplasms
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pathologic Processes
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014