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临床试验/NCT00478257
NCT00478257已完成不适用

Effect of Increased Light Exposure on Fatigue in Breast Cancer

University of California, San Diego2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2005年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
39
试验地点
2
主要终点
Fatigue

研究概览

简要总结

Patients treated with chemotherapy complain of poor sleep, fatigue and depression. In addition, chemotherapy disrupts the body's internal "biological clock", which may make sleep, fatigue and depression all worse. Women with breast cancer undergoing chemotherapy are not exposed to much bright light and this may also contribute to the disruption of their body clock, because bright light is necessary for a strong biological clock. One of the easiest ways to strengthen the biological clock is by increasing bright light exposure. The correct timing of the light exposure will help the women feel more alert during the day.

详细描述

Patients treated with chemotherapy complain of poor sleep, fatigue and depression. Our preliminary research suggests that these symptoms may all be related, that chemotherapy disrupts circadian rhythms which may exacerbate the poor sleep and fatigue and that during chemotherapy, women are not exposed to much bright light which likely also contributes to the disruption of rhythms. One of the easiest circadian rhythms to measure is sleep/wake activity and the easiest way to synchronize this rhythm is with bright light treatment. It is well established that bright light exposure will make rhythms more robust, and the correct timing of the light exposure will have an alerting effect.

We hypothesize that after bright light treatment compared to dim light treatment during three cycles of chemotherapy: fatigue (measured by the Multidimensional Fatigue Symptom Inventory), depression (measured by the Center of Epidemiological Studies-Depression scale), functional outcome scores (measured by the Functional Outcome of Sleep Questionnaire and by the Functional Assessment of Cancer Therapy-Breast), and sleep measures (measured by actigraphy, e.g., total sleep time, total wake time, bouts of sleep, napping) will all be improved. We also hypothesize that circadian rhythms (measured by actigraphy) will be more robust and more synchronized.

The aims are to examine the effect of bright light treatment on subjective measures of fatigue, mood and functional outcome experienced during chemotherapy, to examine the effect of bright light treatment on the quality and quantity of sleep during chemotherapy, to examine the effect of bright light treatment on sleep/wake rhythms during chemotherapy. Women with breast cancer stages I-III scheduled to begin chemotherapy will be recruited. Wrist actigraphy data (for the measurement of sleep/wake activity) will be collected for three consecutive days and nights immediately preceding chemotherapy and questionnaire data (fatigue, mood, quality of life, functional outcome, sleep) will be collected during this same time period. Half the women will be randomized to receive bright light and the other half to dim red light as a control. Daily bright light or dim light treatment will be administered during cycles 2, 3 and 4 of chemotherapy and all measures (actigraphy and questionnaires) will be repeated during the first and last weeks of cycle 1 and cycle 4 chemotherapy. If bright light can improve sleep rhythms and fatigue, then the quality of life of these women is likely to improve.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • stage I-III breast cancer
  • adjuvant or neoadjuvant anthracycline-based chemotherapy

排除标准

  • under age 18
  • pregnancy
  • metastatic or inoperable (including inflammatory) breast cancer
  • confounding underlying medical illnesses
  • history of mania
  • history of other axis-I psychiatric disorder
  • other physical or psychological impairments -

研究组 & 干预措施

1 Active Bright White Light Treatment

Active Comparator

Intervention: Bright white light, the intervention, was administered via a light box made by Litebook Inc for 30 minutes each morning during four cycles of chemotherapy

干预措施: bright white light (Device)

2 Comparator Red Light Treatment

Active Comparator

Intervention: Dim red light, the intervention, was administered via a light box made by Litebook Inc for 30 minutes each morning during four cycles of chemotherapy

干预措施: comparator red light treatment (Device)

结局指标

主要结局

Fatigue

时间窗: four cycles of chemotherapy

The Short Form of the Multidimensional Fatigue Symptom Inventory (MFSI-sf) was used to measure fatigue. The range of possible score for each subscale is 0 to 24, and the range for total score is -24 to 96, with a higher score indicating more severe fatigue, except for the Vigor subscale, where larger score indicates less fatigue.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sonia Ancoli-Israel

Professor

University of California, San Diego

研究点 (2)

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