Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00478257
Status:
COMPLETED
Last Update Posted:
2019-02-06
First Post:
2007-05-22
Brief Title:
Effect of Increased Light Exposure on Fatigue in Breast Cancer
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Effect of Increased Light Exposure on Fatigue in Breast Cancer
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients treated with chemotherapy complain of poor sleep fatigue and depression In addition chemotherapy disrupts the bodys 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
Detailed Description:
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 sleepwake 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 eg 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 sleepwake rhythms during chemotherapy Women with breast cancer stages I-III scheduled to begin chemotherapy will be recruited Wrist actigraphy data for the measurement of sleepwake 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
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 eg 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 sleepwake rhythms during chemotherapy Women with breast cancer stages I-III scheduled to begin chemotherapy will be recruited Wrist actigraphy data for the measurement of sleepwake 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None