Sleep Initiation and Maintenance Disorders
Conditions
Keywords
pain, fatigue, sleep, bone marrow transplant, cancer
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.
Interventions
DRUGEszopiclone
eszopiclone 2 to 3 mg po at bedtime
DRUGPlacebo
placebo 2 to 3 mg po at bedtime
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain | post dosing | Pain was assessed with a 10-cm visual analog scale (0 = no pain at all; 10 = severe, uncontrolled pain). |
| Patient Self-report Data on Fatigue | 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
| Measure | Time frame | Description |
|---|---|---|
| Opiate Dosing From Patient Controlled Analgesia | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Eszopiclone receipt of active drug | 23 |
| Placebo receipt of placebo | 22 |
| Total | 45 |
Baseline characteristics
| Characteristic | Placebo | Eszopiclone | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 0 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 23 Participants | 43 Participants |
| Age, Continuous | 46 years STANDARD_DEVIATION 15.86 | 45.52 years STANDARD_DEVIATION 13.06 | 45.76 years STANDARD_DEVIATION 14.33 |
| Region of Enrollment United States | 22 participants | 23 participants | 45 participants |
| Sex: Female, Male Female | 9 Participants | 13 Participants | 22 Participants |
| Sex: Female, Male Male | 13 Participants | 10 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 23 | 3 / 22 |
| serious Total, serious adverse events | 0 / 23 | 0 / 22 |
Outcome results
Primary
Pain
Pain was assessed with a 10-cm visual analog scale (0 = no pain at all; 10 = severe, uncontrolled pain).
Time frame: post dosing
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eszopiclone | Pain | 3.72 scores on a scale | Standard Error 0.38 |
| Placebo | Pain | 5.41 scores on a scale | Standard Error 0.47 |
Primary
Patient Self-report Data on Fatigue
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).
Time frame: 2 days post treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eszopiclone | Patient Self-report Data on Fatigue | 2.41 scores on a scale | Standard Error 0.2 |
| Placebo | Patient Self-report Data on Fatigue | 2.77 scores on a scale | Standard Error 0.17 |
Secondary
Opiate Dosing From Patient Controlled Analgesia
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.
Time frame: 2 days post dosing
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Eszopiclone | Opiate Dosing From Patient Controlled Analgesia | 36.35 mg |
| Placebo | Opiate Dosing From Patient Controlled Analgesia | 40.94 mg |