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

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ClinicalTrials.gov Identifier: NCT04864405
Recruitment Status : Active, not recruiting
First Posted : April 28, 2021
Last Update Posted : April 21, 2022
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: Morning administration of endocrine therapy Other: Evening administration of endocrine therapy Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 247 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : June 30, 2021
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Morning administration of endocrine therapy
Administration of endocrine therapy defined as, within one hour of the patient wake up time
 Other: Morning administration of endocrine therapy
Endocrine therapy administered within one hour of 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
 Other: Evening administration of endocrine therapy
Endocrine therapy administered within one hour of the patient bed time


Outcome Measures
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Primary Outcome Measures :
  1. Endocrine toxicity and tolerability at 12 weeks [ Time Frame: 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 :
  1. Endocrine toxicity and tolerability [ Time Frame: 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).

  2. Health related quality of life scores [ Time Frame: 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).

  3. Endocrine therapy rates of non-compliance [ Time Frame: 52 weeks after treatment initiation ]
    Rates of non-persistence or non-compliance with initially prescribed endocrine therapy

  4. Cost-effectiveness [ Time Frame: 52 weeks after treatment initiation ]
    Incremental cost-effectiveness rations (cost per one quality-adjusted life year (QALY) gained).


Other Outcome Measures:
  1. Rates of non-compliance to endocrine therapy [ Time Frame: 52 weeks after treatment initiation ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04864405


Locations
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Canada, Ontario
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada, P7B 6V4
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
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Principal Investigator: Marie-France Savard, MD Ottawa Hospital Research Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT04864405    
Other Study ID Numbers: REaCT-CHRONO
First Posted: April 28, 2021    Key Record Dates
Last Update Posted: April 21, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ottawa Hospital Research Institute:
Breast Cancer
Endocrine Therapy
Chronotherapy
Chronotherapeutics
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases