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EORTC 2237-BCG-QLG: Improvement of Quality of Life through supportive treatments for Endocrine Therapy – related symptoms in patients with early Breast cancer; A pragmatic randomized Controlled Trial (QOL-ET-BC)
EU CTIS ID: 2024-513442-10-00
What this study is testing
The primary objective is to evaluate if patients treated in either intervention arm (duloxetine or furosemide) will have better control of the endocrine therapy related MSK pain, particularly arthralgias and/or myalgias and/or bone pain at 3 months.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Female (both pre- and postmenopausal) or male patients
- Completed baseline assessment of patient-reported questionnaires (EORTC QLQ-C30 and EORTC QLQ-BR42)
- Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations
- Patients of childbearing / reproductive potential must agree to use at least one highly effective contraceptive measure until treatment discontinuation
- 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.
- A breastfeeding patient should discontinue nursing prior to the first dose of study treatment and until 1 month after the last study treatment
You likely can't join if
- Current history of grade ≥ 2 CTCAE V5.0 depression and/or anxiety
- Known difficulty in tolerating oral medications or conditions which would impair absorption of oral medications
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol, understanding and completion of questionnaires and follow-up schedule
- Participation in another interventional study with systemic drugs
- History of suicide-related events
- Current use of diuretics, antidepressants and irreversible monoamine oxidase inhibitors (MAOIs)
See the full eligibility criteria
- Female (both pre- and postmenopausal) or male patients
- Completed baseline assessment of patient-reported questionnaires (EORTC QLQ-C30 and EORTC QLQ-BR42)
- Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations
- Patients of childbearing / reproductive potential must agree to use at least one highly effective contraceptive measure until treatment discontinuation
- 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.
- A breastfeeding patient should discontinue nursing prior to the first dose of study treatment and until 1 month after the last study treatment
- Age ≥18 years
- Ongoing adjuvant ET 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 the same ET during the study
- Adjuvant cyclin dependent kinase 4 and 6 (CDK4/6) inhibitor or poly ADP ribose polymerase (PARP) inhibitor treatment is allowed as long as they are planned to be kept during the study duration
- 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
- 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 as defined below: • Glomerular filtration rate estimated via the MDRD equation of ≥ 30 mL/min/1.73m2 • Potassium levels ≥ 3.0 mmol/L • Sodium levels ≥ 130 mmol/L • Total bilirubin <1.5 times the upper limit of normal (ULN) (< 3 times the upper limit of normal for Gilbert’s disease)
- Current history of grade ≥ 2 CTCAE V5.0 depression and/or anxiety
- Known difficulty in tolerating oral medications or conditions which would impair absorption of oral medications
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol, understanding and completion of questionnaires and follow-up schedule
- Participation in another interventional study with systemic drugs
- History of suicide-related events
- Current use of diuretics, antidepressants and irreversible monoamine oxidase inhibitors (MAOIs)
- Current use of prescribed or natural medicines with known interactions with furosemide and/or duloxetine
- Uncontrolled high blood pressure defined as systolic ≥150 mmHg and ≥ diastolic 100 mmHg
- Symptomatic hypotension, hypovolemia, or dehydration
- Addison’s disease
- Porphyria
- Uncontrolled intercurrent illness, including psychiatric conditions, chronic alcoholism, and drug addiction
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Jordan
- Saudi Arabia
- United Arab Emirates
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Jordan; Saudi Arabia; United Arab Emirates. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.