The overall aim of this clinical trial is to improve the knowledge of the pharmacological treatment of insomnia in patients with advanced cancer who use opioids. Despite the high prevalence of insomnia in patients in advanced cancer, there are no randomized controlled data involving pharmacological interventions for insomnia in advanced cancer. Thus, there is a need to evaluate the effectiveness of zopiclone for insomnia patients with advanced cancer.
Conditions
Interventions
Trade Name: Zopiclone
Pharmaceutical Form: Capsule
INN or Proposed INN: zopiklon
CAS Number: 43200-80-2
Other descriptive name: ZOPICLONE
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
St. Olavs Hospital, trondheim University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically verified malignant disease Presence of metastatic / disseminated disease Presence of insomnia syndrome Must be at least 18 years of age Regularly scheduled oral, subcutaneous, transdermal or intravenous opioid treatment dose corresponding to step III at the WHO pain ladder with a stable dose for at least 2 days Able to comply with all study procedures Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: On-going treatment or previous treatment (within 4 weeks) for more than consecutive 3 days with medications given for insomnia. Adverse reactions to zopiclone History of substance abuse Concomitant use of rifampicin and erythromycin Any other contraindication for zopiclone Unfit for participation for any reason as judged by the investigator Severe cognitive impairment as assessed by the investigator Pregnancy or lactation Scheduled surgery within the next week In the need of change in opioid dose at baseline (study visit 1) Scheduled intravenous administration of chemotherapy during the study period (from baseline to day 8) or intravenous administration of chemotherapy during the last week Change in corticosteroid dose last week before baseline or planned dose change within 7 days from baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to study the short time effectiveness of zopiclone on patient reported sleep quality in patients with advanced cancer who use opioids and who report insomnia.;Secondary Objective: The secondary objective is to study the effectiveness of zopiclone on self-reported total sleep time and sleep onset latency;Primary end point(s): Primary endpoint is patient-reported sleep quality during the final study night (night six) assessed on a numerical rating scale (NRS) 0-10. 0= Best sleep, 10=Worst possible sleep.;Timepoint(s) of evaluation of this end point: In the morning after night six, at 9 am | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints are mean values of patient reported total sleep time and sleep onset latency (how long (minutes) it takes to fall asleep) during the final study night (night six).;Timepoint(s) of evaluation of this end point: In the morning after night six, at 9 am | — |
Countries
Norway
Contacts
Public ContactPål Klepstad
St. Olavs Hospital, Trondheim University Hospital
Outcome results
None listed