Randomized Placebo Controlled Study of Minocycline for Amelioration of Chemotherapy Induced Affective Disorders
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Changes in Center for Epidemiological Studies Depression Scale (CES-D) Scores
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: minocycline hydrochloride (Drug)
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.
干预措施: laboratory biomarker analysis (Other)
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.
干预措施: Questionnaire administration (Other)
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.
干预措施: placebo (Other)
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.
干预措施: laboratory biomarker analysis (Other)
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.
干预措施: Questionnaire administration (Other)
结局指标
主要结局
Changes in Center for Epidemiological Studies Depression Scale (CES-D) Scores
时间窗: Baseline to 9 weeks
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
Changes in the State Trait Anxiety Index (STAI) Scores
时间窗: Baseline to 9 weeks
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.
次要结局
- 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)