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

NCT02203552 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: OSU-13165NCI-2014-00851
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Changes in Center for Epidemiological Studies Depression Scale (CES-D) Scores

  CES-D scale a short self-reported scaled designed to measure depressive symptomology in the general population. At baseline, depressive symptom severity will be assessed using the CES-D instrument. Evaluation of the patients assessment if suicidal ideation is reported at baseline. A value of 0, 1, 2, or 3 is assigned to a response depending upon positively or negatively. The subject will be withdrawn from the administrated serially every cycle starts on protocol during clinic visits (Patients will self-administer forms given out by research coordinator).The internal consistency for the STAI is .95; higher scores indicate greater anxiety.41 The internal consistency for the CES-D is approximately .85 among BC patients,42 and an important benefit of using this scale in medical studies is that it is relatively unaffected by physical symptoms. Total scores range from 0-60 with higher scores reflecting greater depressive symptoms. The 95% confidence intervals of the depression change from b

  Baseline to 9 weeks

• Changes in the State Trait Anxiety Index (STAI) Scores

  The mean changes over time in State Trait Anxiety Index (STAI) scores from baseline to the end of study for the two study groups. The influences of covariate, such as disease stage and depression drug usage, will be considered in the mixed models as exploratory analyses. The range of possible scores for form Y of the STAI varies from a minimum score of 20 to a maximum score of 80. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).The 95% confidence intervals of the change in the primary outcome measures from baseline to the end of study and the differences between the treatment and placebo groups will be estimated based on the models.

  Baseline to 9 weeks

Secondary Outcomes (4)

• Changes in Hamilton Anxiety Rating Scale Scores

  Baseline to 9 weeks

• Changes in Hamilton Rating Scale for Depression Scores

  Baseline to 9 weeks

• Changes in Inflammatory Blood Markers

  Baseline to 6 months

• Changes in the PET/MRI Measures

  Baseline to 6 months

Study Arms (2)

Arm I (minocycline hydrochloride)

EXPERIMENTAL

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; Other: laboratory biomarker analysis; Other: Questionnaire administration

Arm II (placebo)

PLACEBO COMPARATOR

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; Other: laboratory biomarker analysis; Other: Questionnaire administration

Interventions

minocycline hydrochloride DRUG

100 mg bid given by mouth for 9 weeks

Also known as: Dynacin, Minocin, Minomax, Minomycin

Arm I (minocycline hydrochloride)

placebo OTHER

Placebo given by mouth for 9 weeks

Also known as: PLCB

Arm II (placebo)

laboratory biomarker analysis OTHER

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.

Also known as: special studies, Correlative studies

Arm I (minocycline hydrochloride); Arm II (placebo)

Questionnaire administration OTHER

The CES-D and STAI will be administrated weekly.

Also known as: Ancillary studies

Arm I (minocycline hydrochloride); Arm II (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Anxiety Disorders; Depression; Breast Neoplasms

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Bhuvaneswari Ramaswamy
• Organization: The Ohio State University Comprehensive Cancer Center

Bhuvaneswari.Ramaswamy@osumc.edu

614-293-7484

Study Officials

• Bhuvaneswari Ramaswamy, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2014
• First Posted: July 30, 2014
• Study Start: June 23, 2015
• Primary Completion: June 15, 2020
• Study Completion: June 15, 2020
• Last Updated: January 8, 2025
• Results First Posted: January 8, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)