Evaluating the Dose Timing (Morning vs Evening) of Endocrine Therapy and Its Effects on Tolerability and Compliance

Sponsor
Ottawa Hospital Research Institute
Study ID
NCT04864405
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Morning administration of endocrine therapy — OTHER
    Endocrine therapy administered within one hour of patient wake up time
  • Evening administration of endocrine therapy — OTHER
    Endocrine therapy administered within one hour of the patient bed time

Study Details

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.

Key Dates

Start date
Jun 30, 2021
Status verified
Dec 2025
Primary completion
Sep 5, 2022
Completion
Jul 29, 2023

Study Design

Enrollment
245 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Morning administration of endocrine therapy
    Administration of endocrine therapy defined as, within one hour of the patient wake up time
  • Active Comparator: Evening administration of endocrine therapy
    Administration of endocrine therapy defined as, within one hour of the patient bed time

Primary Outcome Measure

Change in Endocrine Toxicity and Tolerability at 12 Weeks [ Time Frame: Baseline to 12 weeks after treatment initiation ]

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