At a glance
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A Pragmatic Randomised, Multicentre Trial Evaluating the Dose Timing (Morning vs Evening) of Endocrine Therapy and Its Effects on Tolerability and Compliance (REaCT-CHRONO)
In Brief
A Phase 4 clinical trial evaluating Morning administration of endocrine therapy and Evening administration of endocrine therapy for Breast Cancer. Completed, enrolled 245 participants across 2 sites.
Detailed Summary
Endocrine therapy is an established treatment for hormone receptor-positive breast cancer, but can cause significant side effects with deterioration in quality of life. The side effects of all forms of endocrine therapy are well recognized and can lead to treatment non-persistence or non-compliance. Chronotherapy, also called chronotherapeutics, is defined as the administration of a medication in coordination with circadian rhythm in order to minimize side effects and yield a greater efficacy. The investigators propose to perform a pragmatic, multi-centre, open-label, randomized clinical trial to establish the optimal timing (morning vs. evening) of administering endocrine therapy based on side effects and benefits in early stage breast cancer patients.
Study Details
Timeline
Interventions
Endocrine therapy administered within one hour of patient wake up time
Endocrine therapy administered within one hour of the patient bed time