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

NCT02203552 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-01-08

Study results available
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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

Interventions

DRUG

minocycline hydrochloride

100 mg bid given by mouth for 9 weeks

OTHER

placebo

Placebo given by mouth for 9 weeks

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

Questionnaire administration

The CES-D and STAI will be administrated weekly.

Sponsors & Collaborators

  • Ohio State University Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Bhuvaneswari Ramaswamy, MD · Ohio State University Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-23
Primary Completion
2020-06-15
Completion
2020-06-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02203552 on ClinicalTrials.gov