None listed
Conditions
Brief summary
This study will investigate the effectiveness of temazepam and prolonged release melatonin (melatonin PR) on the sleep quality of patients with advanced cancer experiencing insomnia Who is it for? You may be eligible to join this study if you are aged 18 and above, have been diagnosed with advanced cancer and are experiencing insomnia Study details Participants in this study are randomly allocated (by chance) to one of three groups. Participants in one group will receive temazepam daily for 7 days. Participants in another group will receive melatonin daily for 7 days. And participants in the other group will receive placebo daily for 7 days. Sleep quality, quality of life and global impression of change will be assessed using questionnaires. Participants will have to complete two part questionnaires each day during the treatment. Part one within 2 hours of waking up in the morning and part two at bedtime. Sleep disturbance is a common and distressing problem in patients with advanced cancer. It is important to find ways to help cancer patients sleep better so that their overall quality of life is improved.
Interventions
Arm A: Temazepam 10mg, Day 1 to day 7, once daily 1 oral capsule 30 minutes before bed
Arm B: Melatonin PR 2mg, Day 1 to day 7, once daily 1 oral capsule 30 minutes before bed
Arm C: Placebo, Day 1 to day 7, once daily 1 oral capsule 30 minutes before bed
Sponsors
Western Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient has provided written informed consent Male or female patients aged equal or above 18 years Presence of advanced cancer of any aetiology Patient has an Insomnia Severity Score (ISI) above 11 Australian modified Karnofsky performance status equal or above 40%. Patient is willing and able to comply with the protocol requirements for the duration of the study
Exclusion criteria
Patient has pain or other unstable symptoms that the clinician and patient feels is directly contributing to poor sleep unless the symptom is optimally treated with no potential to change during the course of the study Patients with unstable symptoms can be re-screened once the symptoms are stable Patient who has taken any prescription medication for sleep within 3 days prior to randomisation. Patients on prescription medication for sleep can be re-screened once medication has been ceased for 3 or more days Concurrent use of benzodiazepines for any indication Patient has had more than 2 falls in the past week Patients on varying doses of corticosteroids for any reason during the intervention period or 3 days prior to randomisation Plan for surgery during the study period Formally diagnosed active and uncontrolled alcohol or substance abuse disorder Intolerance to melatonin or temazepam Patient is pregnant or lactating Unstable psychiatric illness as assessed by the clinician Any contraindication listed on the product description for temazepam or melatonin The patient is on another clinical trial of an investigational agent that is likely to interfere with sleep
Outcome results
None listed