Sleep Architecture and Chemotherapy-Related Fatigue
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|ClinicalTrials.gov Identifier: NCT00178204|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : December 5, 2014
The purpose of this study is to identify specific chemotherapy-related changes in sleep stages/architecture that may relate to an increase in fatigue in individuals with cancer.
The researchers hypothesize that the fatigue experienced by cancer patients receiving chemotherapy is in part due to changes in restorative sleeping during the non-rapid eye movement cycles of sleep (i.e., delta activity).
|Condition or disease|
|Fatigue Sleep Cancer|
Studies have shown a strong positive correlation between self-reported changes in sleep and cancer patients' fatigue, and also between an objective measure of sleep continuity, [i.e., actigraphy and polysomnography (PSG)] and self-reported fatigue. Chemotherapy disrupts normal sleep patterns, and fatigue, in the later stages of chemotherapy, may occur as a result of disturbed nocturnal sleep continuity. However, the causes of chemotherapy-related fatigue remain unknown, and whether or not abnormal sleep architecture contributes to this debilitating effect has yet to be explored. We believe that fatigue experienced by many cancer patients receiving chemotherapy is due, at least in part, to changes in delta activity [i.e., restorative sleep during the non-rapid eye movement (NREM) cycles of sleep]. A finding that slow wave sleep abnormalities play a significant role in fatigue would prompt further confirmatory studies and support controlled intervention studies.
Comparisons: In a clinical trial of individuals with cancer prior to, during, and after completion of chemotherapy, we will identify and compare specific chemotherapy-related changes in sleep stages/architecture that may relate to an increase in fatigue. These changes will be measured by actigraphy, PSG, and patient self-reporting techniques (e.g., sleep diaries, questionnaires).
The primary objective is to:
- examine the role of delta sleep in the development of chemotherapy-induced fatigue in cancer patients
Secondary objectives are to:
- characterize the involvement of other elements of sleep architecture [e.g., rapid eye movement (REM) sleep] and changes in sleep continuity relating to the development of chemotherapy-induced fatigue in cancer patients
- examine the role of sleep architecture in the persistence of chemotherapy-induced fatigue
- examine (in post hoc analyses) the relationship of various physical symptoms and patient variables that may be related to fatigue (e.g., pain, hot flashes, anxiety, hemoglobin, menopausal status, sleep continuity, and QOL) and to each other, both during and following chemotherapy.
Answers to these questions will provide information that will be helpful in developing potential targets for interventions to reduce fatigue.
|Study Type :||Observational|
|Actual Enrollment :||26 participants|
|Official Title:||Sleep Architecture and Chemotherapy-Related Fatigue|
|Study Start Date :||November 2004|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||December 2011|
- Polysomnography (PSG) [ Time Frame: Two consecutive nights prior to first chemotherapy, approximately three weeks following the patient's last chemotherapy, and three months following the last treatment. ]Polysomnography provides direct and quantitative measures of cortical activity during sleep (in the form of brain waves). The sleep continuity data derived from this technique include sleep latency (time taken to fall asleep), wake after sleep onset time, total sleep time, and sleep efficiency (SE). The sleep architecture information derived from this technique consists of the assessment of sleep in terms of its constituent component stages (i.e., percent Stage-1, Stage-2, SWS, and REM sleep).
- Brief Fatigue Inventory (BFI) [ Time Frame: On the first night of each of the three polysomnography assessments ]The Brief Fatigue Inventory is a 9-item, patient-report instrument with established reliability and validity that allows for the rapid assessment of fatigue level in cancer patients. Possible scores on this scale range from 0 - 10 with higher numbers indicating greater fatigue.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00178204
|United States, New York|
|University of Rochester James P. Wilmot Cancer Center|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Joesph A Roscoe, Ph.D.||University of Rochester|