Clinical trial · Interventional
Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer
Effect of Eszopiclone (Lunesta) on Sleep Disturbance and Pain in Cancer
NCT00365261CI-TRIAL-00022947completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sleep Initiation and Maintenance Disorders | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Eszopiclone | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- eszopiclone
- description
- active drug
- interventionNames
- Drug: Eszopiclone
- type
- PLACEBO_COMPARATOR
- label
- placebo
- description
- placebo
- interventionNames
- Drug: Placebo
Primary outcomes (2)
- measure
- Pain
- timeFrame
- post dosing
- description
- Pain was assessed with a 10-cm visual analog scale (0 = "no pain at all"; 10 = "severe, uncontrolled pain").
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female patients hospitalized for chemotherapy or blood/bone marrow transplant. 2. Age 20 - 75 3. Not currently regularly taking any prescribed sleeping pill more often than 4x/week. 4. Can tolerate oral medication. Exclusion Criteria: 1. Patients with a current history of substance abuse 2. Patients with a history of allergic response to Lunesta. 3. Patient who require additional oral or parenteral opioids after starting PCA opioid treatment.
References
Publications (1)
- RESULTDimsdale JE, Ball ED, Carrier E, Wallace M, Holman P, Mulroney C, Shaikh F, Natarajan L. Effect of eszopiclone on sleep, fatigue, and pain in patients with mucositis associated with hematologic malignancies. Support Care Cancer. 2011 Dec;19(12):2015-20. doi: 10.1007/s00520-010-1052-1. Epub 2010 Nov 30. PMID 21116652