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Sponsored by: |
University of California, San Diego |
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Information provided by: | University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT00365261 |
To assess the effectiveness of Lunesta on cancer patients who have received a blood or marrow transplant and who require patient controlled analgesia (PCA), specifically to assess whether Lunesta will:
Condition | Intervention | Phase |
---|---|---|
Sleep Initiation and Maintenance Disorders |
Drug: eszopiclone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Effect of Eszopiclone (Lunesta) on Sleep Disturbance and Pain in Cancer |
Estimated Enrollment: | 50 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | March 2009 |
Pain and fatigue are the most common symptom complaints of cancer patients. Although dramatic improvements have come about in recognizing and treating cancer related pain, less progress has been made in treating fatigue. Interventions to improve sleep may offer benefit in terms of pain and fatigue.
One of the less commonly recognized side effects of opiate use is sleep disruption.
Experimentally-induced sleep disruption lowers the threshold for detection of painful stimuli. Thus, although opiates are obviously helpful for pain, they do so at certain "costs": they increase next day fatigue, constipation, and have other side effects; they disrupt sleep which further increases next day fatigue; and finally, by virtue of their sleep disruptive properties, they lower the threshold for pain stimuli.
Cancer patients requiring blood/bone marrow transplants (BMT) commonly require PCA because of oral mucositis. The objective of this study is to assess whether opiate usage may be reduced and complaints of fatigue and pain be lessened if patients had better sleep.
Ages Eligible for Study: | 20 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
UCSD Thornton Hospital | Recruiting |
La Jolla, California, United States, 92037 | |
Contact: Joel E Dimsdale, MD 619-543-5592 jdimsdale@ucsd.edu | |
Principal Investigator: Joel E Dimsdale, MD |
Principal Investigator: | Joel E Dimsdale, MD | UCSD |
Study ID Numbers: | UCSD 060340, ESRC 054 |
Study First Received: | August 15, 2006 |
Last Updated: | June 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00365261 |
Health Authority: | United States: Institutional Review Board |
pain fatigue sleep bone marrow transplant cancer |
Sleep Initiation and Maintenance Disorders Signs and Symptoms Fatigue Mental Disorders Neurologic Manifestations |
Dyssomnias Sleep Disorders Pain Sleep Disorders, Intrinsic |
Nervous System Diseases |