Systematic Light Exposure to Prevent Fatigue in Prostate Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Fatigue FACIT-Fatigue scores
研究概览
简要总结
Fatigue due to cancer and its treatment (for example, radiation therapy) can interfere with quality of life and can linger long after treatment has ended, yet research examining preventative approaches has produced limited clinical benefit. The proposed study will provide information about systematic light exposure for the prevention of fatigue in prostate cancer patients undergoing radiation therapy and will investigate how it works. This study would facilitate the development of this potential preventative treatment, giving health care providers and cancer survivors a much-needed tool to help with cancer-related fatigue.
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)
盲法说明
Participants will be randomized to one of two arms: an intervention light group or a comparison light group. Both the participant and the investigator will be blind to the light assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Have been diagnosed with clinical localized prostate cancer,
- •Are about to begin external beam radiation therapy (RT) for prostate cancer,
- •Are 18 years of age or older,
- •Are able to speak or read English,
- •Have internet access.
排除标准
- •History of light therapy use (e.g. systematic light exposure),
- •Active infection
- •History of chronic fatigue disorders
- •Confounding underlying medical illnesses such as significant pre-existing anemia (Hb<10 gm/dl)
- •Diagnosed or suspected psychiatric or medical condition that might contribute to fatigue (other than those caused by the cancer or its treatment)
- •Hypothyroidism or documented history of hypothyroidism on thyroid replacement hormone within <3 months of initiating RT
- •History of bipolar disorder or mania
- •History of seasonal affective disorder
- •Diagnosed sleep apnea, restless legs, or other sleep disorders (not including insomnia) known to affect fatigue
- •Use of photosensitizing medication
- •Plans to travel across more than 2 time zones during the study
- •Shift worker
- •Adults unable to consent, individuals who are not yet adults, pregnant women, and prisoners will be excluded from the study
结局指标
主要结局
Fatigue FACIT-Fatigue scores
时间窗: Baseline
FACIT-Fatigue scores
Fatigue
时间窗: Change from Baseline to 2 months after the intervention
FACIT-Fatigue scores
次要结局
- Sleep quality(2 months after the intervention)
- Cognitive functioning(2 months after the intervention)
- Sexual and urinary functioning(2 months after the intervention)
- Health-related quality of life(2 months after the intervention)
- Circadian activity rhythms(2 months after the intervention)
- Depressed mood(2 months after the intervention)
- Cognitive Functioning(2 months after the intervention)
研究者
Lisa M. Wu
Assistant Professor
Northwestern University