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OpenTrials
Completed

NCT Number: NCT00365261

Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer

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

Completed

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UCSD Thornton Hospital

La Jolla, California, 92037, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients hospitalized for chemotherapy or blood/bone marrow transplant.
  • Age 20 - 75
  • Not currently regularly taking any prescribed sleeping pill more often than 4x/week.
  • Can tolerate oral medication.

Exclusion criteria

  • Patients with a current history of substance abuse
  • Patients with a history of allergic response to Lunesta.
  • Patient who require additional oral or parenteral opioids after starting PCA opioid treatment.

Treatment and study plan

Eszopiclone

Drug

eszopiclone 2 to 3 mg po at bedtime

Other names: Lunesta

Placebo

Drug

placebo 2 to 3 mg po at bedtime

Primary outcomes

  1. Pain

    Time frame: post dosing

    Pain was assessed with a 10-cm visual analog scale (0 = "no pain at all"; 10 = "severe, uncontrolled pain").

  2. Patient Self-report Data on Fatigue

    Time frame: 2 days post treatment

    Patients completed the five-item Profile of Mood States Scale, Short Form (POMS-SF) Fatigue-Inertia Scale to rate their fatigue complaints (scores range from 0 to 28; higher scores denote more fatigue).

Secondary outcomes

  1. Opiate Dosing From Patient Controlled Analgesia

    Time frame: 2 days post dosing

    Morphine or dilaudid dose delivered at fixed rate with optional self-administered prn boluses. Dilaudid doses were converted into morphine equivalents by multiplying the dose by 5.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

Effect of Eszopiclone (Lunesta) on Sleep Disturbance and Pain in Cancer

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Aug 17, 2006
Registry last updated
Jul 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.