Viewing Study NCT00365261



Ignite Creation Date: 2024-05-05 @ 4:59 PM
Last Modification Date: 2024-10-26 @ 9:27 AM
Study NCT ID: NCT00365261
Status: COMPLETED
Last Update Posted: 2016-07-11
First Post: 2006-08-15

Brief Title: Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer
Sponsor: University of California San Diego
Organization: University of California San Diego

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
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

Study Oversight

Has Oversight DMC: None
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?: None
Secondary IDs
Secondary ID Type Domain Link
ESRC 054 OTHER Sepracor None