RecruitingPhase 2ACTRN12619001284156

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


Sponsor

University of Sydney

Enrollment

51 participants

Start Date

Sep 1, 2022

Study Type

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

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Many women with breast cancer who are taking hormone-blocking therapy (such as tamoxifen or aromatase inhibitors) experience significant sleep problems. Poor sleep affects quality of life, mood, and overall health, yet there are few well-studied treatments specifically for this group. This trial is testing whether melatonin — a natural hormone the body makes to regulate sleep — can help improve sleep in women receiving hormone-blocking treatment for breast cancer. Participants will be randomly and blindly assigned to take either melatonin tablets or a placebo (dummy tablets) every evening before bed for 12 weeks. Neither the participant nor the research team will know which they are taking until the study is complete. Sleep will be monitored using questionnaires and a wrist-worn activity tracker (actigraph watch), and participants will keep a medication diary. You may be eligible if you are female, 18 or older, have stage 1 to 3 breast cancer, have been on hormone-blocking therapy for at least 3 months, and have poor sleep that started or worsened after your breast cancer diagnosis. Women with sleep apnoea, those currently using sleeping medications, or those working regular night shifts are not eligible. This trial offers a simple, non-invasive way to potentially address one of the most common and distressing side effects of breast cancer treatment.

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

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)

Concord Repatriation Hospital - Concord

NSW, Australia

Macarthur Cancer Therapy Centre - Campbelltown

NSW, Australia

Southern Highlands Private Hospital - Bowral

NSW, Australia

The Northern Beaches Hospital - Frenchs Forest

NSW, Australia

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ACTRN12619001284156


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