NCT01980719已完成不适用
Molecular Determinants of Persistent Cancer Related Fatigue
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Compare peripheral immune markers (cytokines), C-reactive protein levels and brain neurotransmitters (glutamate, GABA, myoinositol, and resting state intrinsic connectivity).
研究概览
简要总结
The purpose of this study is to determine if inflammatory markers in blood as well as brain neurotransmitters (markers of in-brain activity and metabolism) are related to long-term or chronic fatigue.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All Participants:
- •Women age 18 or older with no contraindication to magnetic resonance imaging(MRI);
- •Fatigued BC Participants:
- •Have a diagnosis of breast cancer;
- •And have completed all cancer-related treatments (i.e., surgery, chemotherapy, radiotherapy, immunotherapy, etc.) except for hormonal therapy and or herceptin at least 12 weeks previously; and be apparently cancer-free.
- •Age-Matched, Healthy Participants:
- •Generally healthy;
- •Matched in age ± 2.5 years to a Fatigued BC participant.
- •No prior history of any cancer except for basal cell or squamous cell tumors of the skin that have been surgically excised;
- •Have good sleep quality
- •Have no chronic pain
- •Have no chronic fatigue
排除标准
- •Pregnant, wanting to become pregnant or lactating women ;
- •Diagnosed with anemia [defined as hemoglobin levels < 12 gm/dl] or receiving treatment for anemia ;
- •Diagnosed with any comorbidities likely to cause significant fatigue (i.e., moderate to severe heart failure)
- •Diagnosed with nutritional deficiencies;
- •Have a diagnosis of untreated hypo- or hyper-thyroidism
- •Have an initiation, a cessation or change of dose (up to three weeks prior to the study's start) of any chronic medications or dietary supplements or any planned change of chronic medications or dietary supplements during the study;
- •Have implanted (e.g., surgical clips or staples) metal objects.
结局指标
主要结局
Compare peripheral immune markers (cytokines), C-reactive protein levels and brain neurotransmitters (glutamate, GABA, myoinositol, and resting state intrinsic connectivity).
时间窗: 6 weeks
次要结局
- Compare fatigue, pain, and sleep quality with peripheral immune markers, CRP, and brain markers.(6 weeks)
研究者
Suzanna Zick
Research Associate Professor
University of Michigan
研究点 (1)
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