Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04864405
Status:
COMPLETED
Last Update Posted:
2023-08-07
First Post:
2021-04-09
Brief Title:
Evaluating the Dose Timing Morning vs Evening of Endocrine Therapy and Its Effects on Tolerability and Compliance
Sponsor:
Ottawa Hospital Research Institute
Organization:
Ottawa Hospital Research Institute
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None