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

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

NCT ID: NCT06407401

Condition: ER+ Breast Cancer
HER2-negative Breast Cancer
Breast Cancer Stage I
Breast Cancer Stage II
Breast Cancer Stage III
Drug-Related Side Effects and Adverse Reactions
Musculoskeletal Pain

Conditions: Official terms:
Breast Neoplasms
Musculoskeletal Pain
Drug-Related Side Effects and Adverse Reactions
Furosemide
Duloxetine Hydrochloride

Conditions: Keywords:
Quality of Life

Study type: Interventional

Study phase: Phase 3

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Duloxetine 60 MG
Description: 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.
Arm group label: Experimental arm SoC with duloxetine

Intervention type: Drug
Intervention name: Furosemide 40 mg
Description: 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.
Arm group label: Experimental arm SoC with Furosemide

Intervention type: Behavioral
Intervention name: Booklet for healthy behaviors
Description: All patients will receive usual care, including a booklet focused on healthy behaviors, particularly physical exercise, to manage endocrine therapy side-effects.
Arm group label: Control arm (SoC)
Arm group label: Experimental arm SoC with Furosemide
Arm group label: Experimental arm SoC with duloxetine

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 ER+/HER2- early breast cancer with joint, muscle and/or 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 and/or 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 [joint/bone/muscle pain]) for, at least, 4 weeks before enrolment will be centrally randomized 1:1:1 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.

Criteria for eligibility:
Criteria:
Inclusion criteria: - Female (both pre- and postmenopausal) or male patients - Age ≥18 years - Ongoing adjuvant ET (tamoxifen or OFS plus tamoxifen or OFS plus AI or AI ) for ER positive HER2 negative breast cancer stages I-III - Patients must have received at least 3 months and up to 3 years of ET and planned to continue ET during the study conduction - Present endocrine therapy related MSK pain (arthralgia and/or bone pain and/or myalgias), evaluated by the treating clinician as at least grade 2 CTCAE V5.0 for, at least, 4 weeks before enrolment, at the time of the clinic visit: - Grade 2: moderate pain; limiting instrumental activities daily living (ADL) - Grade 3: severe pain; limiting activities self-care ADL - Previous chemotherapy is allowed if completed at least 3 months before enrolment - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 - Adequate organ function - Completed baseline assessment of patient-reported questionnaires (EORTC QLQ-C30 and EORTC QLQ breast module) - Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations - Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 7 days prior to the first dose of study treatment. Note: women of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e., females who have had any evidence of menses in the past 12 months, except for those who had prior hysterectomy). However, women who have been amenorrhoeic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antioestrogens, low body weight, ovarian suppression, or other reasons. - Patients of childbearing / reproductive potential must agree to use at least one acceptable effective contraceptive measure until treatment discontinuation. - Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 1 month after the last study treatment. Exclusion criteria: - Current history of moderate/severe depression and/or anxiety, both defined as grade≥2 CTCAE V5.0 - History of suicide-related events - Current use of diuretics, antidepressants and/or phytoestrogens - Current use of prescribed or natural medicines with known interactions with furosemide and/or duloxetine - Contraindications to duloxetine: - Severe renal impairment (creatinine clearance < 30 mL/min) - Uncontrolled hypertension - Hepatic impairment Child Pugh Class B or C - Contraindications to furosemide: - Symptomatic hypotension, hypovolemia, or dehydration - Severe renal impairment (creatinine clearance < 30 mL/min) - Severe hypokalaemia and/or severe hyponatremia - Addison's disease - Porphyria - Uncontrolled intercurrent illness, including psychiatric conditions, chronic alcoholism, and drug addiction, that would, in the judgment of the investigator, limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent. - Known difficulty in tolerating oral medications or conditions which would impair absorption of oral medications such as: uncontrolled nausea or vomiting (i.e., CTCAE ≥ Grade 3 despite antiemetic therapy), ongoing gastrointestinal obstruction/motility disorder, malabsorption syndrome, or prior gastric bypass - Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol, understanding and completion of questionnaires and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the trial. - Participation in another interventional study with drugs.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: December 2024

Completion date: November 30, 2028

Lead sponsor:
Agency: European Organisation for Research and Treatment of Cancer - EORTC
Agency class: Other

Source: European Organisation for Research and Treatment of Cancer - EORTC

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06407401