The Role of Circadian Rhythms in Cancer-Related Symptoms: A Prospective Controlled Chrono-Bio-Behavioral Observation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Cancer related symptoms composite score change
研究概览
简要总结
Emerging evidence indicates that circadian rhythms may be disrupted following cancer and its treatment, and that circadian rhythm disruption may be an underlying pathophysiological mechanism of cancer- and cancer treatment-related symptoms (CRS) such as fatigue, sleep disturbance, cognitive impairment, and depressed mood. Given the detrimental effect of CRS on cancer survivors' quality of life, and a pressing demand for effective interventions to treat CRS, there is a need for a comprehensive examination of circadian disruption related to cancer and its treatment, and its association with CRS. The study will prospectively examine circadian rhythms and a CRS composite score in recently diagnosed breast cancer patients from prior to surgery or chemotherapy to 12 months later. A matched healthy control group will serve as a comparison.
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
- •Patients with early breast cancer scheduled for surgery and chemotherapy (neoadjuvant or adjuvant) at Aarhus University Hospital (AUH).
- •The healthy control group will consist of an age-matched sample of participants with no history of cancer.
排除标准
- •Pregnancy
- •Shift-work
- •Melatonin supplementation
- •Insufficient Danish proficiency
- •Previous cancer diagnosis except for treated non-melanoma skin cancer
- •Confounding diagnosed or suspected psychiatric or medical conditions that might significantly contribute to the CRS or symptoms/diagnoses resembling them (other than those caused by cancer or its treatment) such as seasonal affective disorder.
结局指标
主要结局
Cancer related symptoms composite score change
时间窗: Change from baseline to time 4 (through study completion, an average of 1 year)
A composite score will be calculated based on measures of fatigue, sleep, cognition, and depression as described under secondary outcomes
Dim light melatonin onset change
时间窗: Change from baseline to time 4 (through study completion, an average of 1 year)
Melatonin based on saliva samples
Circadian Activity Rhythms change
时间窗: Change from baseline to time 4 (through study completion, an average of 1 year)
Rest/wake activity recorded with wrist actigraphy
Circadian skin temperature change
时间窗: Change from baseline to time 4 (through study completion, an average of 1 year)
Distal skin temperature recorded with wrist actigraphy
次要结局
- Sleep quality change(Change from baseline to time 4 (through study completion, an average of 1 year))
- Inflammatory markers change(Change from baseline to time 4 (through study completion, an average of 1 year))
- Insomnia change(Change from baseline to time 4 (through study completion, an average of 1 year))
- Cognitive functioning change(Change from baseline to time 4 (through study completion, an average of 1 year))
- Depression change(Change from baseline to time 4 (through study completion, an average of 1 year))
- Cancer-related fatigue change(Change from baseline to time 4 (through study completion, an average of 1 year))
- Stress change(Change from baseline to time 4 (through study completion, an average of 1 year))
- Self-reported quality of life change(Change from baseline to time 4 (through study completion, an average of 1 year))
- Sleep change(Change from baseline to time 4 (through study completion, an average of 1 year))
- Self-reported cognitive functioning change(Change from baseline to time 4 (through study completion, an average of 1 year))
研究者
Ali Amidi
Assistant Professor
Aarhus University Hospital