Status:
COMPLETED
Sleep Architecture and Chemotherapy-Related Fatigue
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
American Cancer Society, Inc.
Conditions:
Fatigue
Sleep
Eligibility:
All Genders
18+ years
Brief Summary
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 hypot...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00178204
Start Date
November 1 2004
End Date
December 1 2011
Last Update
December 5 2014
Active Locations (1)
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1
University of Rochester James P. Wilmot Cancer Center
Rochester, New York, United States, 14642