Treatment of sleep disturbance (insomnia) in patients with advanced cancer who use pain killers (opioids).

Phase 1

Active, not recruiting

Conditions: 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.
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2015-005306-11-NO

Lead Sponsor: St. Olavs Hospital, trondheim University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 100

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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