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 EXAI Study"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 74
- 试验地点
- 17
- 主要终点
- Effect of a training program in quality of life questionnaire (QoL)-related to endocrine therapy
研究概览
简要总结
This is a national clinical trial (Spain), conducted in approximately 5 sites, where patients who agree to participate will be included in one of two exercise program groups: the experimental group (a combined resistance and aerobic exercise program) and the control group.
The study will begin with a pilot phase involving approximately 74 patients.
Approximately 37 patients in the experimental group will follow a 6-month training program consisting of exercise sessions three alternate days per week (combining resistance and aerobic exercise).
Approximately 37 patients in the control group will receive standard medical care. These patients will be provided with international exercise guidelines for cancer patients.
Patients will continue with their assigned physical activity intervention until the maximum number of months for the intervention, unacceptable toxicity, discontinuation of hormone therapy, or withdrawal of consent-whichever occurs first.
详细描述
Study population:
The target population for randomization in this study includes women diagnosed with Hormone receptor (HR)+/Human epidermal growth factor receptor 2 (HER2)-negative- early-stage breast cancer (EBC) and who have already received between 10 and 18 weeks of an AI (with or without a LHRHa) before the randomization in the study. Those patients that are candidates to receive an adjuvant CDK4/6i should have initiated the treatment at least 6 weeks before the randomization in the study.
Study treatment:
Although patients should receive adjuvant ET (including an AI [steroidal inhibitors such as exemestane or non-steroidal inhibitors such as anastrozole or letrozole], with or without a CDK4/6i and with or without a LHRHa) to be eligible for this study, the clinical decisions concerning the optimum management strategy for a particular patient will be taken independently of and prior to any decision by the investigator to invite a patient to participate in the study and according to the approved product information, local treatment guidelines and/or routine clinical practice.
The EX-AI study has been developed to be pragmatic as it adheres to local guidelines for the use of ET in the adjuvant setting. There are no extra tests or assessments required as we allow patients management to follow the standard of care. The burden on patients is limited to completing the training program and questionnaires/scales. The diagnostic and monitoring procedures used do not introduce any risk or burden beyond those associated with routine clinical practice in Spain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 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.
- •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 American Society of Clinical Oncology (ASCO)/ College of American Pathologists (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 candidate 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.
- •With the consent of the investigator for participation in physical training and considering the medical history of the patient.
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.
研究组 & 干预措施
Control group
Approximately 37 patients in the control group will receive usual health care. This patients' group will be provided with the international exercise guidelines for cancer patients.
Experimental group
Approximately 37 patients in the experimental group will perform a 6-month training program consisting of exercise sessions 3 alternating days per week (combined resistance + aerobic exercise).
干预措施: Training program (Behavioral)
结局指标
主要结局
Effect of a training program in quality of life questionnaire (QoL)-related to endocrine therapy
时间窗: Through study treatment, and average of 12 months
To determine the changes from baseline in the QoL-related to endocrine therapy (ET) symptoms measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer 45 (EORTC QLQ-BR45) questionnaire (questions 54-56, 63-69). To calculate the scores for each desirable dimension Scoring Manuals will be followed. Summary statistics (mean, mean confidence interval (CI), standard deviation, median and range) of absolute scores and their changes from baseline will be summarized at each assessment time. The comparison between treatment groups will be performed using a linear mixed model. Patients will complete this questionnaire at at baseline and during physical activity intervention: 1.5, 3, 6 and 12 months.
次要结局
- Body composition(Through study treatment, and average of 12 months)
- Change from baseline in global QoL(Through study treatment, and average of 12 months)
- Aromatase inhibitor associated musculoskeletal syndrome (AIMSS)(Through study treatment, and average of 12 months)
- Fatigue(Through study treatment, and average of 12 months)
- Adherence to the physical activity program(Through study treatment, and average of 12 months)
- Tolerability to the treatment(Through study treatment, and average of 12 months)
- Compliance to treatment(Through study treatment, and average of 12 months)
- Information on sexual relations: libido(Through study treatment, and average of 12 months)
- Information on sexual relations: body image(Through study treatment, and average of 12 months)
- Information on sexual relations: vaginal dryness(Through study treatment, and average of 12 months)
- Cognitive impairment(Through study treatment, and average of 12 months)
- The Number of Participants Who Experienced Adverse Events (AE) Related to Study Treatment(Through study treatment, and average of 12 months)