Impact of Prehabilitation With Exercise and Nutrition, and Comprehensive Follow-up in Women With Breast Cancer: The PREACT Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Cardiorespiratory fitness (peak oxygen consumption): Direct method
研究概览
简要总结
Breast cancer (BC) is the most common cancer among women worldwide. Cancer treatments are associated with numerous adverse events that reduce patients' functionality and alter their clinical and molecular profiles. Physical exercise and adherence to nutritional guidelines during treatment and survivorship have been shown to improve recovery prognosis and reduce treatment-related complications. However, the specific effects of prehabilitation, defined as "the process in the cancer continuum that occurs between diagnosis and the start of treatment," remain unknown in BC. A concurrent training program and specific nutritional guidelines during this phase could reduce treatment-related adverse events and improve recovery. Similarly, including a home-based exercise program and nutritional guidelines throughout the cancer treatment continuum could enhance the benefits achieved and improve various aspects of functionality, clinical status, and quality of life. Therefore, the main aim of this randomized controlled trial is to evaluate the impact and effects of a supervised prehabilitation program (combining high-intensity concurrent training and personalized nutritional guidelines) and a supportive care intervention (home-based exercise and personalized nutritional guidelines) on functional, neuromuscular, and cardiorespiratory capacity, quality of life, body composition, and clinical and molecular outcomes in women with BC. In addition, the sustainability of the benefits achieved in the long-term care and the evolution of the outcomes assessed throughout the continuum of cancer treatments will be analyzed.
详细描述
The administration of breast cancer (BC) treatments is associated with various adverse events and acute toxicities that negatively affect molecular, functional, and clinical outcomes in patients with BC. Additionally, these adverse events may reduce treatment tolerance [e.g., relative dose intensity (RDI)], which has been shown to be associated with a worse prognosis in this population. Implementing a high-intensity concurrent training program and specific nutritional guidelines during this phase could reduce adverse treatment events and improve recovery. Likewise, including an unsupervised exercise program and nutritional guidelines during the rest of the cancer treatment may enhance the benefits obtained and improve different outcomes related to the patients' functionality, clinical status, quality of life, and treatment tolerance. Therefore, the aim of this study is to determine the effects of a prehabilitation program (combining high-intensity concurrent training and personalized nutritional guidelines) and a supportive care intervention (home-based exercise and personalized nutritional guidelines) on different outcomes in newly diagnosed women with BC.
This prospective, two-arm parallel randomized controlled trial will be conducted in Valladolid (Castilla y León, Spain). A total of 66 newly diagnosed women with BC will be recruited through medical and diagnostic appointments. Women will be recruited immediately after diagnosis and must be scheduled to receive neoadjuvant chemotherapy or hormone therapy, surgery, or radiation therapy. After completion of baseline study assessments, participants will be randomized to an experimental group or a control group. Participants assigned to the experimental group will undergo a supervised prehabilitation program consisting of structured exercise training and personalized nutritional guidelines, followed by a home-based program during the medical treatment period. Participants in the control group will be asked to continue their usual care and will receive general recommendations for physical exercise and nutrition. Molecular (inflammation-related proteins, epinephrine and norepinephrine), functional (cardiorespiratory fitness, 30-Second Sit-to-Stand Test, Six-Minute Walk Test, handgrip strength and maximal voluntary isometric contraction), clinical (body composition, muscle thickness, and arm volume), and patient-reported (quality of life, upper-limb disability, fatigue, 24-hour nutritional record and food frequency questionnaire) outcomes will be assessed at baseline (week 0) and at various points during the scheduled cancer-associated treatments. Treatment tolerance (relative dose intensity, dose reduction, dose delay, early discontinuation of treatment, and number of patients completing the planned total dose) and treatment-related complications (seroma, infection; hematoma, wound dehiscence, persistent post-surgical pain, lymphedema, neuropathy, and thromboembolism) will be recorded throughout the continuum of treatments.
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
盲法说明
The person analyzing the data collected (investigators, statisticians) will not know to which group each person belongs.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who have a newly confirmed diagnosis of stage 0-III breast cancer.
- •Age 18 to 65 years old with a body mass index between 18.5 and 35 kg·m-².
- •Have a medical indication for surgery or neoadjuvant systemic treatment (chemotherapy or hormone therapy) or radiotherapy.
- •Be able to perform supervised physical exercise, as determined by prior medical assessment.
- •Understand and voluntarily sign the written informed consent before the start of the study.
排除标准
- •Women with a diagnosis of metastatic breast cancer.
- •Women with any medical condition that contraindicates physical exercise, such as severe cardiovascular disease, significant respiratory or kidney failure.
- •Women with presence of serious uncontrolled comorbidities, such as decompensated diabetes, severe hypertension or acute psychiatric disorders, among others.
- •Women with severe functional limitations that prevent planned interventions from being performed (e.g., physical disabilities that compromise exercise).
- •Women who are pregnant, breastfeeding, or likely to become pregnant during the trial or who have inability to communicate.
研究组 & 干预措施
Exercise and nutrition group
Participants assigned to the experimental group will undergo a supervised prehabilitation program consisting of structured exercise training and personalized nutritional guidelines, followed by a home-based program (exercise and nutrition) during the treatment period.
干预措施: Prehabilitation: Exercise and nutrition (Other)
Control group
Participants assigned to this group will be asked to continue their usual care and will receive general recommendations for physical activity and nutrition.
结局指标
主要结局
Cardiorespiratory fitness (peak oxygen consumption): Direct method
时间窗: Baseline; up to 1 week before initiation of systemic therapy; up to 1 week after completion of systemic therapy; up to 1 week before initiation of radiotherapy; and up to 1 week after completion of radiotherapy.
The change in peak oxygen consumption (ml·kg-¹·min-¹) will be assessed. A Wattbike AtomX cycle ergometer (Wattbike, Nottingham, England) and a stationary gas analyzer (Cortex Metalyzer 3B, Leipzig, Germany) will be used in the study. A gradual incremental exercise protocol will be applied, starting at 50 watts with increments of 25 watts every two minutes, until voluntary exhaustion is reached or medical reasons are presented to end exercise.
Cardiorespiratory fitness: Indirect method (30-Second Sit-to-Stand Test)
时间窗: Baseline; up to 1 week after prehabilitation; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
The change in the estimated peak of oxygen consumption (ml·kg-¹·min-¹) will be assessed.
Cardiorespiratory fitness: Indirect method (Six-Minute Walk Test)
时间窗: Baseline; up to 1 week after prehabilitation; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
The change in the estimated peak of oxygen consumption (ml·kg-¹·min-¹) will be assessed.
次要结局
- Handgrip strength(Baseline; up to 1 week after prehabilitation; 1 week post-surgery, up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks))
- Upper-body maximal voluntary isometric contraction: Chest press(Baseline; up to 1 week after prehabilitation; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks))
- Lower-body maximal voluntary isometric contraction: Squat(Baseline; up to 1 week after prehabilitation; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).)
- Inflammation-related proteins(Baseline; up to 1 week after prehabilitation; 1 week after surgery or immediately after completion of the first treatment.)
- Epinephrine and norepinephrine(Baseline; 1 week before initiation of the first treatment (radiotherapy, chemotherapy or hormone therapy).)
- Weight(Baseline; up to 1 week after prehabilitation; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).)
- Height(Baseline; up to 1 week after prehabilitation; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).)
- Body composition (Bioimpedance)(Baseline; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).)
- Muscle thickness: vastus lateralis(Baseline; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).)
- Physical activity levels(Baseline and up to 4 weeks.)
- Muscle thickness: rectus femoris(Baseline; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).)
- Arm volume(Baseline; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).)
- Health-related quality of life(Baseline; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).)
- Upper-limb disability(Baseline; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).)
- Self-reported pain(Baseline; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).)
- Fatigue(Baseline; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).)
- Dietary intake(Baseline; up to 1 week after prehabilitation; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).)
- Treatment-related complications(Through study completion, an average of 1 year.)
- Length of hospitalization(Through study completion, an average of 1 year.)
- Cardiorespiratory fitness (peak ventilation)(Baseline; up to 1 week before initiation of systemic therapy; up to 1 week after completion of systemic therapy; up to 1 week before initiation of radiotherapy; and up to 1 week after completion of radiotherapy.)
- Cardiorespiratory fitness (mean and peak heart rate)(Baseline; up to 1 week before initiation of systemic therapy; up to 1 week after completion of systemic therapy; up to 1 week before initiation of radiotherapy; and up to 1 week after completion of radiotherapy.)
- Cardiorespiratory fitness (peak respiratory quotient)(Baseline; up to 1 week before initiation of systemic therapy; up to 1 week after completion of systemic therapy; up to 1 week before initiation of radiotherapy; and up to 1 week after completion of radiotherapy.)
- Physical function (30-Second Sit-to-Stand Test)(Baseline; up to 1 week after prehabilitation; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).)
- Physical function (Six-Minute Walk Test)(Baseline; up to 1 week after prehabilitation; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).)
- Treatment tolerance (relative dose intensity)(Through study completion, an average of 1 year.)
- Treatment tolerance (dose reduction)(Through study completion, an average of 1 year.)
- Treatment tolerance (dose delay)(Through study completion, an average of 1 year.)
- Treatment tolerance (early treatment discontinuation)(Through study completion, an average of 1 year.)
- Treatment tolerance (completion of planned total dose)(Through study completion, an average of 1 year.)