Cancer Clinical Trial
Official title:
Sleep Architecture and Chemotherapy-Related Fatigue
Verified date | December 2014 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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).
Status | Completed |
Enrollment | 26 |
Est. completion date | December 2011 |
Est. primary completion date | May 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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) |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester James P. Wilmot Cancer Center | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester | American Cancer Society, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Polysomnography (PSG) | 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). | Two consecutive nights prior to first chemotherapy, approximately three weeks following the patient's last chemotherapy, and three months following the last treatment. | No |
Secondary | Brief Fatigue Inventory (BFI) | 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. | On the first night of each of the three polysomnography assessments | No |
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