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Sleep Architecture and Chemotherapy-Related Fatigue

18 Years
Not Enrolling
Fatigue, Sleep, Cancer

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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

- 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.

Inclusion Criteria:

- Have a diagnosis of cancer and not have had chemotherapy during the prior three years

- Be scheduled for chemotherapy that is expected to last at least 9 weeks but not more
than 33 weeks without concurrent interferon treatment. Radiation therapy is allowed
provided it is concluded within the 33 week time period

- Have a stable sleep/wake schedule (no shift work) with a preferred sleep phase
between 10:00 PM and 9:00 AM

- Be 18 years of age or older

- Give informed consent

- If on beta blockers or being treated for depression or a thyroid disorder, the
medication has been stable for 3 months

Exclusion Criteria:

- On a short term basis (less than 3 months), taking any prescription medication for
the control of anxiety, sleep, depression, or fatigue OR taking any over-the-counter
medications known to affect sleep

- Diagnosed with post-traumatic stress disorder (PTSD) or have a substance abuse
disorder or psychotic disorder (currently or by history)

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:

Polysomnography (PSG)

Outcome Description:

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).

Outcome 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.

Safety Issue:


Principal Investigator

Joesph A Roscoe, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Rochester


United States: Institutional Review Board

Study ID:




Start Date:

November 2004

Completion Date:

December 2011

Related Keywords:

  • Fatigue
  • Sleep
  • Cancer
  • delta sleep
  • Cancer-related fatigue
  • Sleep Disturbance
  • chemotherapy
  • Fatigue



University of Rochester James P. Wilmot Cancer Center Rochester, New York  14642