Physiology of Chemotherapy Induced Fatigue and Cognitive Dysfunction in Early Stage Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Treatment-related fatigue as assessed by a brief fatigue inventory, a Brief Mental Fatigue Questionnaire, and a motor fatigability task with concurrent physiological measurements at baseline, during treatment, and 1 year after treatment completion
研究概览
简要总结
RATIONALE: Gathering information over time from women undergoing chemotherapy for breast cancer may help doctors learn more about mental and physical fatigue caused by treatment.
PURPOSE: This clinical trial is studying fatigue caused by chemotherapy in women who have undergone surgery for stage I, stage II, or stage III breast cancer and in healthy volunteers.
详细描述
OBJECTIVES:
- To assess treatment-related fatigue, cognitive dysfunction, and recovery in women undergoing adjuvant chemotherapy for stage I-III breast cancer as compared with a patient-selected control population.
- To determine whether fatigue induced by sustained isometric contraction (SIC) is more of central or peripheral (muscular) origin in patients with and without treatment-related fatigue.
- To characterize changes from baseline in potential abnormal signal processing in the brain while performing cognitive-assessment testing (CAT) in patients experiencing chemotherapy-related cognitive dysfunction compared with the controls.
OUTLINE: Patients and participants undergo assessment of treatment-related fatigue and cognitive dysfunction (i.e., mental fatigue) at baseline, after completion of 3-4 courses of standard adjuvant chemotherapy, and 1-3 weeks after completion of the most recent treatment. Patient recovery will be assessed at approximately 1 year from baseline. Study assessments will include a brief fatigue inventory, a cognitive assessment, and muscle fatigability testing through a sustained isometric contraction. Additional assessments will include quantification of brain and muscle signal alterations in patients with and without treatment-related fatigue and cognitive-assessment testing in patients experiencing chemotherapy-related cognitive dysfunction.
Patients and participants also undergo collection of data to obtain information on patient age, body mass index, and menopausal status at baseline and at 1 year. Additional information is collected on type of chemotherapy treatment and any hormonal or other anticancer treatments administered throughout the course of the study. Cancer recurrences or new cancer events are also recorded.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Treatment-related fatigue as assessed by a brief fatigue inventory, a Brief Mental Fatigue Questionnaire, and a motor fatigability task with concurrent physiological measurements at baseline, during treatment, and 1 year after treatment completion
时间窗: at baseline, after completion of 3-4 courses of standard adjuvant chemotherapy, and 1-3 weeks after completion of the most recent treatment.
Cognitive function as assessed by the Wechsler Adult Intelligence Scale III at baseline, during treatment, and 1 year after treatment completion
时间窗: at baseline, after completion of 3-4 courses of standard adjuvant chemotherapy, and 1-3 weeks after completion of the most recent treatment.
Characterization of potential abnormal signal processing in the brain in patients experiencing chemotherapy-related cognitive dysfunction as evaluated by cognitive-assessment testing and high-density EEG
时间窗: measurements at baseline, during treatment, and 1 year after treatment completion
Recovery at 1 year
时间窗: at 1 year
Quantification of brain and muscle signal alteration in patients and controls with and without treatment-related fatigue as assessed by high-density EEG or EMG and force
时间窗: measurements at baseline, during treatment, and 1 year after treatment completion
次要结局
未报告次要终点