2025-522848-40-00招募中4 期
Impact of EXercise on quality of life of early breast cancer patients on treatment with adjuvant Aromatase Inhibitors with or without CDK4/6 inhibitors. "The EX-AI study"
Fundacion Grupo Espanol De Investigacion En Cancer De Mama2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2025年12月29日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- The primary endpoint will consist on determining of the changes from baseline in the QoL-related to ET symptoms measured by the EORTC QLQ-BR45 questionnaire (questions 54-56, 63-69).
研究概览
简要总结
The primary objective of this study is to evaluate the effect of a 6-month training program in QoL-related to ET.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent document (ICD) prior to any specific study procedures, showing patience, willingness and ability to comply with the physical activity program in the experimental group, and scheduled visits and study procedures in both groups.
- •With the consent of the investigator for participation in physical training and considering the medical history of the patient.
- •Patients ≥18 years of age at signing of ICD.
- •Documented histologically confirmed HR+/HER2− invasive EBC, adequately treated according to standard clinical practice and with absence of any evidence of disease (loco-regional or metastatic at distance). HR and HER2 assessments are performed under institutional guidelines. HR testing should utilize an assay consistent with the most recent ASCO/CAP Guidelines. HER2 negativity is determined as immunohistochemistry (IHC) score 0/1+ or negative by in situ hybridization (ISH) according to the recommendations of the most recent ASCO/CAP Guidelines.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-
- •Pre-, peri-, and post-menopausal women (as determined by the investigator and according to the institutional guidelines) that have already received between 10 and 18 weeks of an AI (with or without a LHRHa) before the randomization in the study and administered according to local guidelines. NOTE: Patients that are candidates to receive an adjuvant CDK4/6i will only be eligible if the CDK4/6i was initiated at least 6 weeks before the randomization in the study and administered according to local guidelines.
- •Patients must have undergone adequate (definitive) loco-regional therapy (surgery with or without radiation therapy), with or without neo-/adjuvant systemic CT
- •Patients must have an adequate organ and bone marrow function according to the standard clinical practice and institutional guidelines
- •Patients must be able and willing to fill out repeated questionnaires on QoL, pain and fatigue, as well as to adhere to the physical activity program.
- •Fluent Spanish language skills for the complete comprehension of the questionnaires.
排除标准
- •Patients have received less than 10 weeks or more than 18 weeks of an AI (with or without a LHRHa) before the randomization in the study.
- •Patients that are candidate to receive an adjuvant CDK4/6i initiated the treatment less than 6 weeks before the randomization in the study.
- •Patients have musculoskeletal injuries.
- •Patients have known significant heart disease (myocardial infarction, unstable angina, congestive heart failure, cardiomyopathy, etc.).
- •Patients with weight over 150kg.
- •Patients have any type of illness or mental condition that prevents or compromises the well-being of the patient or compliance with the procedures.
- •Patients have any cardiovascular contraindication to physical training by the investigator.
- •Patients have been performing supervised training, either aerobic and/or resistance training (at a gym [group or individual classes] or in a specific sport), at least 2 days per week in the past 6 months.
- •No access and/or unable to manage the website and other digital tools (i.e. applications) for training sessions.
结局指标
主要结局
The primary endpoint will consist on determining of the changes from baseline in the QoL-related to ET symptoms measured by the EORTC QLQ-BR45 questionnaire (questions 54-56, 63-69).
The primary endpoint will consist on determining of the changes from baseline in the QoL-related to ET symptoms measured by the EORTC QLQ-BR45 questionnaire (questions 54-56, 63-69).
次要结局
- Change from baseline in global QoL that will be evaluated by questions 29-30 of the EORTC QLQ-C30 questionnaire.
- AIMSS will be assessed using the Brief Pain Inventory (BPI) scale.
- Fatigue will be measured by the Brief Fatigue Inventory (BFI) scale.
- Adherence and compliance to treatment will be recorded using the pill counting method and patient diary
- Body composition will be measured by bioimpedance scale. Weight, body mass index (BMI), lean, muscle and fat mass (including visceral fat), water percentage, bone density and basal metabolic rate will be collected
- Adherence to the exercise program will be recorded through the exercise professionals’ assistance and assessment through the virtual training platform (called “10 Mets”).
- Sexual relations (libido, body image and vaginal dryness) will be evaluated through the specific items included in the EORTC QLQ-BR45 questionnaire (questions 39-42, 44-46 and 70-73).
- Cognitive impairment will be evaluated through the specific items included in the EORTC QLQ-C30 questionnaire (questions 20 and 25).
- Safety will be assessed by standard clinical and laboratory tests (hematology, serum chemistry). Adverse events (AEs) grade will be defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 5.0. Tolerability will be assessed by incidence of treatment dose modifications, discontinuations due to AEs, number of administered cycles, dose intensity, etc.
研究者
Clinical Operations Department
Scientific
Fundacion Grupo Espanol De Investigacion En Cancer De Mama
研究点 (2)
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