Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer

University of California San Diego

Status and phase: Completed; Phase 4

Conditions: Sleep Initiation and Maintenance Disorders

Treatments: Drug: Placebo; Drug: Eszopiclone

Study type: Interventional

Funder types: Other

Identifiers

NCT00365261

UCSD 060340

ESRC 054 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

45 participants in 2 patient groups, including a placebo group

eszopiclone

Active Comparator group

Description:

active drug

Treatment:

Drug: Eszopiclone

placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Placebo