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

Breast Cancer Clinical Trial

Official title:

A Pragmatic Randomised, Multicentre Trial Evaluating the Dose Timing (Morning vs Evening) of Endocrine Therapy and Its Effects on Tolerability and Compliance (REaCT-CHRONO)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04864405
• Other study ID #: REaCT-CHRONO
• Status: Completed
• Phase: Phase 4
• Start date: June 30, 2021
• Est. completion date: July 29, 2023

Study information

• Verified date: August 2023
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: July 29, 2023
• Est. primary completion date: September 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

• Metastatic cancer
• Previous endocrine therapy for breast cancer

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Canada	The Ottawa Hospital Cancer Centre	Ottawa	Ontario
Canada	Thunder Bay Regional Health Sciences Centre	Thunder Bay	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rates of non-compliance to endocrine therapy	Comparing rates of non-compliance and non-persistence to endocrine therapy with patient age, turmour stage, chemotherapy use and type of endocrine therapy. The rates of non-compliance and rates of non-persistence will be tracked throughout the duration of the study and then compared to patient age, tumour stage, chemotherapy use and the type of endocrine therapy used.	52 weeks after treatment initiation
Primary	Endocrine toxicity and tolerability at 12 weeks	Measured by the change in total Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) questionnaire from baseline to 12 weeks following the beginning of endocrine therapy. FACT-ES is a validated sub scale of the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system. FACT-ES consists of 46 items on a 5 point Likert type scale ranging from 0 (not at all) to 4 (very much). It is designed to measure five domains of health related quality of life in breast cancer patients receiving endocrine therapy: physical, social, emotional, functional well-being as well as an endocrine symptom sub-scale (ESS).	12 weeks after treatment initiation
Secondary	Endocrine toxicity and tolerability	Measured by the change in total score and individual Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) questionnaires from baseline to 4, 8, 12 and 52 weeks following the beginning of endocrine therapy. FACT-ES consists of 46 items on a 5 point Likert type scale ranging from 0 (not at all) to 4 (very much). It is designed to measure five domains of health related quality of life in breast cancer patients receiving endocrine therapy: physical, social, emotional, functional well-being as well as an endocrine symptom sub-scale (ESS).	Baseline, 4, 8, 12 and 52 weeks after treatment initiation
Secondary	Health related quality of life scores	Measured by the change in the total score and individual sub scales of the validated Functional Assessment of Cancer Therapy for patients with Breast cancer (FACT-B) questionnaire from baseline to 4, 8, 12 and 52 weeks following the beginning of endocrine therapy. The FACT-B consists of 37 items on a 5 point Likert type scale ranging from 0 (not at all) to 4 (very much). It is designed to measure five domains of health related quality of life in breast cancer patients: physical, social, emotional, functional well-being as well as a breast-cancer sub-scale (BCS).	Baseline, 4, 8, 12 and 52 weeks after treatment initiation
Secondary	Endocrine therapy rates of non-compliance	Rates of non-persistence or non-compliance with initially prescribed endocrine therapy	52 weeks after treatment initiation
Secondary	Cost-effectiveness	Incremental cost-effectiveness rations (cost per one quality-adjusted life year (QALY) gained).	52 weeks after treatment initiation