2024-513442-10-00撤回3 期
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)
Europese Organisatie Voor Onderzoek En Behandeling Van Kanker Organisation Europeenne Pour La Recherche Et Le Traitement Du Cancer European Organi9 个研究点 分布在 5 个国家目标入组 252 人开始时间: 2025年2月11日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 252
- 试验地点
- 9
- 主要终点
- Change from baseline in the skeletal scale as assessed by the EORTC QLQ-BR42 at month 3. • The skeletal scale score is computed based on the following four individual items from the EORTC QLQ-BR42 questionnaire Have you had problems with your joints? • Have you had stiffness in your joints? • Have you had pain in your joints? • Have you had aches or pains in your bones?
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
- •Uncontrolled intercurrent illness, including psychiatric conditions, chronic alcoholism, and drug addiction
结局指标
主要结局
Change from baseline in the skeletal scale as assessed by the EORTC QLQ-BR42 at month 3. • The skeletal scale score is computed based on the following four individual items from the EORTC QLQ-BR42 questionnaire Have you had problems with your joints? • Have you had stiffness in your joints? • Have you had pain in your joints? • Have you had aches or pains in your bones?
Change from baseline in the skeletal scale as assessed by the EORTC QLQ-BR42 at month 3. • The skeletal scale score is computed based on the following four individual items from the EORTC QLQ-BR42 questionnaire Have you had problems with your joints? • Have you had stiffness in your joints? • Have you had pain in your joints? • Have you had aches or pains in your bones?
次要结局
- Discontinuation of endocrine therapy
- Change from baseline in the skeletal scale as assessed by the EORTC QLQ-BR42 questionnaire at month 6
- Change from baseline in Global health status/QoL scale according to EORTC-QLQ-C30 questionnaire at 3 and 6 months
- Change from baseline in Emotional functioning scale according to EORTC-QLQ-C30 questionnaire at 3 and 6 months
- Change from baseline Endocrine therapy symptoms scale according to EORTC-BR42 questionnaire at 3 and 6 months
- Safety according to the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0 for toxicity and Serious Adverse Event reporting
研究者
Stéphanie Kromar
Scientific
Europese Organisatie Voor Onderzoek En Behandeling Van Kanker Organisation Europeenne Pour La Recherche Et Le Traitement Du Cancer European Organi
研究点 (9)
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