University of Rochester James P. Wilmot Cancer Center
Rochester, New York, 14642, United States
NCT Number: NCT00178204
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).
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Notify Me18 year and older
All sexes
Observational
Rochester, New York, 14642, United States
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:
Secondary objectives are to:
Answers to these questions will provide information that will be helpful in developing potential targets for interventions to reduce fatigue.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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.
University of Rochester
Other
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