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

Phase 4

Completed

• Conditions: Breast Cancer

• Registration Number: NCT04864405
• Lead Sponsor: Ottawa Hospital Research Institute

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-04-09
• Study First Submitted QC: 2021-04-27
• Study First Posted: 2021-04-28
• Study Start: 2021-06-30
• Primary Completion: 2022-09-05
• Study Completion: 2023-07-29
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-03
• Last Update Posted: 2023-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 247

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Endocrine toxicity and tolerability at 12 weeks	12 weeks after treatment initiation	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).

Secondary Outcome Measures

Name	Time	Method
Health related quality of life scores	Baseline, 4, 8, 12 and 52 weeks after treatment initiation	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).
Endocrine therapy rates of non-compliance	52 weeks after treatment initiation	Rates of non-persistence or non-compliance with initially prescribed endocrine therapy
Cost-effectiveness	52 weeks after treatment initiation	Incremental cost-effectiveness rations (cost per one quality-adjusted life year (QALY) gained).
Endocrine toxicity and tolerability	Baseline, 4, 8, 12 and 52 weeks after treatment initiation	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).

Trial Locations

Locations (2)

The Ottawa Hospital Cancer Centre; 🇨🇦 Ottawa, Ontario, Canada

Thunder Bay Regional Health Sciences Centre; 🇨🇦 Thunder Bay, Ontario, Canada