Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2026-02-25 @ 8:15 PM
Study NCT ID:
NCT00365261
Status:
COMPLETED
Last Update Posted:
2016-07-11
First Post:
2006-08-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer
Sponsor:
University of California, San Diego
Organization:
Study Overview
Official Title:
Effect of Eszopiclone (Lunesta) on Sleep Disturbance and Pain in Cancer
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the effectiveness of Lunesta on cancer patients who have received chemotherapy and who require patient controlled analgesia (PCA), specifically to assess whether Lunesta will:
* improve sleep thereby decreasing need for opiates via PCA
* improve sleep thereby decreasing pain by self report
* improve sleep thereby decreasing fatigue by self report
* improve sleep thereby decreasing need for opiates via PCA
* improve sleep thereby decreasing pain by self report
* improve sleep thereby decreasing fatigue by self report
Detailed Description:
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 chemotherapy 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.
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 chemotherapy 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ESRC 054 | OTHER | Sepracor | View |