Improvement of Quality of Life Through Supportive Treatments for Hormone Therapy - Related Symptoms in Patients With Early Breast Cancer

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

399

Participants

Timeline

Start Date

December 31, 2024

Primary Completion Date

April 18, 2028

Study Completion Date

November 30, 2028

Conditions
ER+ Breast CancerHER2-negative Breast CancerBreast Cancer Stage IBreast Cancer Stage IIBreast Cancer Stage IIIDrug-Related Side Effects and Adverse ReactionsMusculoskeletal Pain
Interventions
DRUG

Duloxetine 60 MG

"Patients randomized to the duloxetine arm will take duloxetine orally daily, with or without food, on a continuous dosing schedule.~Initial dose is 30 mg daily for 1 week, followed by 60 mg daily for a total of 6 months of treatment, followed by a taper off the medication of 30 mg daily for 1 additional week."

DRUG

Furosemide 40 mg

Patients randomized to the furosemide arm will take furosemide 40 mg orally daily, on an empty stomach with plenty of liquid, on a continuous dosing schedule.

BEHAVIORAL

Booklet for healthy behaviors

All patients will receive usual care, including a booklet focused on healthy behaviors, particularly physical exercise, to manage endocrine therapy side-effects.

All Listed Sponsors
lead

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK