Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06407401
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-06
Brief Title:
Improvement of Quality of Life Through Supportive Treatments for Hormone Therapy - Related Symptoms in Patients With Early Breast Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Improvement of Quality of Life Through Supportive Treatments for Hormone Therapy - Related Symptoms in Patients With Early Breast Cancer A Pragmatic Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
This study is a pragmatic international multicenter randomized open label 3- arm trial of standard care vs two pharmacological interventions duloxetine or furosemide in patients with stage I-III ERHER2- early breast cancer with joint muscle andor bone pain caused by the endocrine therapy
The purpose of the BC-QOL trial is to find out whether treatment with duloxetine or furosemide given while patients are on treatment with endocrine therapy is active in improving quality of life QoL specifically by improving joint muscle andor bone pain caused by the endocrine therapy based on EORTC QLQ-BR42 skeletal scale
The purpose of the BC-QOL trial is to find out whether treatment with duloxetine or furosemide given while patients are on treatment with endocrine therapy is active in improving quality of life QoL specifically by improving joint muscle andor bone pain caused by the endocrine therapy based on EORTC QLQ-BR42 skeletal scale
Detailed Description:
Patients identified by their clinicians as suffering from Grade 2 or above endocrine therapy-related musculoskeletal symptoms jointbonemuscle pain for at least 4 weeks before enrolment will be centrally randomized 111 between
Control arm Standard of care SoC including a booklet focused on healthy behaviors
Experimental arm Duloxetine 60 mg 1 pill a day SoC
Experimental arm Furosemide 40 mg 1 pill a day SoC
Treatment duration will be 6 months All patients will receive usual care including a booklet focused on healthy behaviors particularly physical exercise to manage endocrine therapy side-effects Treatment administration and modifications as well as specific monitoring should be done in accordance to the SmPC of the corresponding drugs
Control arm Standard of care SoC including a booklet focused on healthy behaviors
Experimental arm Duloxetine 60 mg 1 pill a day SoC
Experimental arm Furosemide 40 mg 1 pill a day SoC
Treatment duration will be 6 months All patients will receive usual care including a booklet focused on healthy behaviors particularly physical exercise to manage endocrine therapy side-effects Treatment administration and modifications as well as specific monitoring should be done in accordance to the SmPC of the corresponding drugs
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