A Pilot Study to Investigate the Effect of Cytotoxic Therapy and/or Radiotherapy on Cancer Related Sleep Disturbances in CLL and Breast Cancer Patients Experiencing Fatigue
The goal of this clinical research study is to learn if treatments to kill cancer cells including lenalidomide and/or radiation therapy can help to control symptoms such as sleep problems and fatigue in patients with chronic lymphocytic leukemia (CLL) and/or breast cancer.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Open Label Study to Investigate the Effect of Cytotoxic Therapy and/or Radiotherapy Including Lenalidomide on Cancer Related Sleep Disturbances in Chronic Lymphocytic Leukemia (CLL) and Breast Cancer Patients Experiencing Clinically Significant Fatigue|
- Total Sleep Time as measured by polysomnography (PSG) [ Time Frame: Before and after 1st cycle of Lenalidomide treatment (57days (+/- 3 days)) ] [ Designated as safety issue: No ]Sleep record scored by registered polysomnographic technologists according to the standard criteria of Rechtschaffen and Kales. Records scored for total sleep time, number of minutes of wake after sleep onset (WASO), number of awakenings, sleep latency, sleep efficiency, and percentages of stages 1,2,3,4, and REM sleep, as well as cortical arousals (defined as sudden increases in electroencephalogram frequency of at least 3 second duration, following at least 10 seconds of continuous sleep, with or without accompanying muscle activity).
|Study Start Date:||November 2008|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Experimental: Sleep time
Assessment of patients with chronic lymphocytic leukemia (CLL) experience severe cancer related fatigue (CRF):
Lenalidomide + Actigraph + Questionnaire + Sleep Test
5 mg daily for 56 days.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00792077
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Sriram Yennurajalingam, MD||M.D. Anderson Cancer Center|