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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-30

Study Completion Date

2023-07-29

Brief Summary

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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.

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Detailed Description

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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. Compliance is defined as the degree or extent of conformity to the recommended administration by the provider, whereas persistence refers to the act of continuing treatment for a certain prescribed duration. Treatment adherence is especially important in breast cancer, as early cessation or reduced compliance to hormonal therapy are associated with reduced disease-free survival and increased mortality. 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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Morning administration of endocrine therapy

Administration of endocrine therapy defined as, within one hour of the patient wake up time

Group Type ACTIVE_COMPARATOR

Morning administration of endocrine therapy

Intervention Type OTHER

Endocrine therapy administered within one hour of patient wake up time

Evening administration of endocrine therapy

Administration of endocrine therapy defined as, within one hour of the patient bed time

Group Type ACTIVE_COMPARATOR

Evening administration of endocrine therapy

Intervention Type OTHER

Endocrine therapy administered within one hour of the patient bed time

Interventions

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Morning administration of endocrine therapy

Endocrine therapy administered within one hour of patient wake up time

Intervention Type OTHER

Evening administration of endocrine therapy

Endocrine therapy administered within one hour of the patient bed time

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with an early stage or locally advanced hormonal receptor positive breast cancer
* Plan to receive endocrine therapy
* 18 years of age or older
* Able to provide oral consent
* Willing and able to complete questionnaires as per study protocol