Trial Information

Sleep Architecture and Chemotherapy-Related Fatigue

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.