OvS Breast: ENBI Project, Ovarian Suppression in Breast Cancer: Exercise, Nutrition and Behavioural Intervention Project
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Combined intervention evaluation on weight control
研究概览
简要总结
The goal of this clinical trial is to compare a combined intervention based on physical exercise, nutritional control, and individualized psycho-oncological support can achieve weight control and maintain adequate body composition in premenopausal women with localized BC with ER and/or PR expression who receive aLHRH in combination with TAM or AI as part of adjuvant treatment.
The study's primary objectives are to evaluate the impact of the combined intervention on weight reduction and favorable modification of body composition in terms of reduction in body fat and increase in lean mass.
The secondary objectives aim to evaluate the impact of the combined intervention program on CRF, heart rate (HR), capillary lactate levels, upper and lower body strength, physical functionality, and patient-reported outcomes (PROs). (exercise level, asthenia, self-perception, anxiety and depression), blood count and biochemistry values that could be modified, nutritional situation, and side effects of treatments.
详细描述
Breast cancer (BC) is the most common and incident neoplasia in women in Spain and is the third cause of cancer death after lung and colorectal cancer. In turn, BC with hormone receptor expression is the most common and corresponds to approximately 75% of BC cases.
Suppression of ovarian function combined with endocrine treatment (gonadotropin-releasing hormone analog (LHRH) associated with tamoxifen (TAM) or aromatase inhibitors (AI)) has demonstrated a benefit in terms of relapse-free survival (PFS) and overall survival (OS) in premenopausal women diagnosed with localized BC with estrogen receptor (ER) and progesterone (PR) expression. This benefit is mainly focused on patients diagnosed at younger ages (under 45 years) and those with other clinical-pathological factors that imply an exceptionally high risk of relapse.
Despite their benefits, the adverse effects of these treatments are not trivial and include significant toxicities in the cardiorespiratory, metabolic, sexual, and emotional spheres. Metabolic alterations include unfavorable changes in body composition with increases in the percentage of fat and weight that can be observed already in the first months of treatment, which in turn is directly related to an increased risk of BC relapse in these patients.
Changes in body composition with increased fat and decreased muscle mass lead to a pro-inflammatory and dysfunctional state of the immune system, which in turn has been linked to the development of cardiovascular diseases and a worse oncological prognosis.
Scientific evidence suggests that nutritional interventions combined with physical exercise and adapted to physiological needs, the baseline physical level, and the adverse effects derived from the treatments can be safe and effective in achieving adequate weight control and body composition. All of this would favor restoring the immune system's functionality and increasing patients' cardiorespiratory capacity (CRF), which could ultimately translate into a better quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who have reached the age of majority and up to 45 years of age.
- •Premenopausal status is defined clinically as a patient who maintains menstruation prior to the start of chemotherapy treatment if this has taken place.
- •Confirmed histological diagnosis of infiltrating breast carcinoma with expression of ER and/or RP stage I to III.
- •Loco-regional treatment with surgery and radiotherapy, if any, completed.
- •Adjuvant treatment with drugs that suppress ovarian function (aLHRH) is ongoing and expected to be maintained for at least 4 months at the beginning of the study.
- •Functional status according to the Eastern Cooperative Oncology Group (ECOG) scale 0-
- •Ability to understand and agree to the Informed Consent in writing.
排除标准
- •Presence of medical contraindications to perform physical exercise.
- •Presence of any of the American Thoracic Society (ATS) criteria to perform a cardiovascular capacity test.
- •Presence of active neoplastic disease: metastatic breast cancer or other active tumor diseases.
- •Pregnancy or breastfeeding.
- •Alcohol or other drug abuse (excluding smoking).
研究组 & 干预措施
Group 1, control
Group 1/Control: patients will receive the basic recommendations on healthy lifestyle habits indicated by the World Health Organization (WHO) through audiovisual material that they will receive via email. An explanatory video and a document with WHO guidelines will be included (https://apps.who.int/iris/bitstream/handle/10665/337004/9789240014817-spa.pdf).
干预措施: Basic recommendations (Behavioral)
Group 2, experimental
Group 2/ Exercise, nutrition, and psycho-oncological support: patients will carry out a cardiovascular and strength exercise program of moderate-high intensity at the facilities of the Exercise and Cancer Center organized in sessions of 60 to 75 minutes in duration, with a frequency of 2 days/week for 12 weeks; In addition, 3 sessions of nutritional counseling and 3 sessions of psycho-oncological intervention will be developed.
干预措施: Physical exercise (Behavioral)
Group 2, experimental
Group 2/ Exercise, nutrition, and psycho-oncological support: patients will carry out a cardiovascular and strength exercise program of moderate-high intensity at the facilities of the Exercise and Cancer Center organized in sessions of 60 to 75 minutes in duration, with a frequency of 2 days/week for 12 weeks; In addition, 3 sessions of nutritional counseling and 3 sessions of psycho-oncological intervention will be developed.
干预措施: Nutritional advice (Behavioral)
Group 2, experimental
Group 2/ Exercise, nutrition, and psycho-oncological support: patients will carry out a cardiovascular and strength exercise program of moderate-high intensity at the facilities of the Exercise and Cancer Center organized in sessions of 60 to 75 minutes in duration, with a frequency of 2 days/week for 12 weeks; In addition, 3 sessions of nutritional counseling and 3 sessions of psycho-oncological intervention will be developed.
干预措施: Psycho-oncological support (Behavioral)
结局指标
主要结局
Combined intervention evaluation on weight control
时间窗: 1 year
A combined intervention based on physical exercise, nutritional control, and individualized psycho-oncological support can achieve weight control and maintain adequate body composition in premenopausal women with localized breast cancer expressing estrogen receptors and progesterone receptors who receive adjuvant treatment. The psycho-oncological intervention program aims to increase motivation to adhere to the physical exercise program and nutritional recommendations and maintain long-term healthy lifestyle habits.
Combined intervention evaluation in body composition
时间窗: 1 year
The variables weight, kilograms, fat mass, lean mass, and extracellular water will be obtained with the Tanita BC-601 Gold scale, including an impedance meter. The height, waist, and hip circumferences will be obtained with a tape measure. These measurements are necessary for calculating the BMI and the waist-high index (measure in centimeters). Weight and height will be combined to report BMI in kg/m\^2 Units of measure: weight in kilograms, height in meters.
次要结局
- Improve Quality of Life on Patient Report Outcomes(1 year)
- Nutritional Status follow-up(1 year)
- Psycho-oncological assessment(1 year)
- Cardiorespiratory Fitness: Evaluation of physical activity performance(1 year)
- Endurance performance: Evaluation of physical activity performance:(1 year)
- Strength: Evaluation of physical activity performance(1 year)
- Physical functionality: Evaluation of physical activity performance(1 year)