Randomized Placebo Controlled Study of Minocycline for Amelioration of Chemotherapy Induced Affective Disorders

Who is this study for? Patients with Breast Cancer
Status: Completed
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus
Time Frame
Start Date: 2015-06-23
Completion Date: 2020-06-15
Participants
Target number of participants: 56
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Ohio State University Comprehensive Cancer Center

This content was sourced from clinicaltrials.gov