Phase 2
Completed N=56
Minocycline Hydrochloride in Reducing Chemotherapy Induced Depression and Anxiety in Patients With Stage I-III Breast Cancer
Anxiety · Depression · Recurrent Breast Cancer · Stage IA Breast Cancer
Source: ClinicalTrials.gov NCT02203552 ↗
Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: Changes in Center for Epidemiological Studies Depression Scale (CES-D) Scores — 0.57; -3.18 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Center for Epidemiological Studies Depression Scale (CES-D) Scores |
0.57; -3.18 | — |
| PRIMARY Changes in the State Trait Anxiety Index (STAI) Scores |
-5.86; -9.41 | — |
| SECONDARY Changes in Hamilton Anxiety Rating Scale Scores |
— | — |
| SECONDARY Changes in Hamilton Rating Scale for Depression Scores |
— | — |
| SECONDARY Changes in Inflammatory Blood Markers |
0.04; 0; 0.17; 0.26; 0.07; 0.14 | — |
| SECONDARY Changes in the PET/MRI Measures |
— | — |
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)
Data sourced from ClinicalTrials.gov (NCT02203552). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.