Melatonin for sleep disturbance in breast cancer patients
Phase II randomised control trial of melatonin versus placebo for the management of sleep disturbance in women with early stage breast cancer on adjuvant endocrine therapy
University of Sydney
51 participants
Sep 1, 2022
Interventional
Conditions
Summary
The purpose of this study is to see if melatonin supplementation can help improve sleep in women receiving hormone blocking therapy for breast cancer. Who is it for? You may be eligible for this study if you are aged 18 or over, have stage 1-3 breast cancer, are taking hormone blocking therapy and have trouble sleeping. Study details Participants in this study will be randomised by chance into two groups. One group will take melatonin tablets every evening before bed for 12 weeks. The other group will take a placebo tablet every evening before bed for 12 weeks. Neither the participants nor the researchers will know which participants are taking which tablets. All participants will complete questionnaires, complete a medication diary and wear an atigraph watch to measure your sleep. It is hoped this research will demonstrate the usefulness of melatonin in improving sleep in breast cancer patients.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Oral melatonin slow release 2mg tablets taken daily 1-2 hours before bedtime for 12 weeks Participants will complete a medication diary and pill counts will be performed
Locations(4)
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ACTRN12619001284156