Precision Physical Exercise for Personalized Onco-Hematology.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Functional physical condition
研究概览
简要总结
Physical exercise, particularly strength training, has become an effective strategy to improve physical function, muscle mass, and quality of life in cancer patients. However, the biological mechanisms underlying these benefits remain poorly understood, especially during active treatment. The PEPOH project (Precision physical Exercise for Personalized Onco-Hematology) proposes a single-center clinical trial conducted at the Fundación del Instituto de Investigación Biomédica de Salamanca (FIBSAL) including five different patient cohorts: lung, colorectal (CRC), and breast cancer, chronic lymphocytic leukemia, and multiple myeloma. Participants will be randomly assigned to either an in-person intervention group, performing a supervised strength training program twice a week for 12 weeks combined with a home-based exercise program, or a control group performing only the home-based program. Biological samples will be collected before and after the intervention for multi-dimensional characterization (Genomics, Transcriptomics, Proteomics and Metabolomics) and systematic integration with parameters of functional capacity, quality of life, psychological well-being, frailty, and body composition. The main objective of the project is to determine biological parameters associated with strength exercise and their relationship with clinical parameters related to prognosis, therapy response and survival. This multi-dimensional approach will enable the detection of exercise adaptation biomarkers and generate knowledge about the mechanisms linking exercise with improved health outcomes in individuals with cancer. PEPOH will contribute to biomedical science and will enhance the comprehensive care of oncohematologic patients by integrating multi-omic and clinical data into a precision exercise model. This project will also contribute to society by offering a cost-effective, safe, and transferable intervention, which increases the overall quality of life.
详细描述
The main aim of the PEPOH project is to characterise and predict clinical response to strength training in solid and/or hematological tumors in patients (under active therapy and/or during the therapy process) by an exhaustive and systematic integration of multi-omics datasets to determine signatures associated with treatment tolerance, disease progression and overall survival.
Several specific objectives derive from this main goal:
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- Determine the immunomodulator effect of physical exercise by deciphering differential molecular profiles in peripheral blood by next-generation sequencing (RNA, SNPs, CHIP), proteomics and metabolomics, which provide novel insights for a comprehensive analysis of the effect of exercise on patients
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- Evaluate the impact of a physical exercise programme in oncohematological patients on multidimensional indicators of their intrinsic capacity related to overall quality of life:
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- Functional physical condition (muscle strength, walking speed, balance, and fatigue).
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- Psychological well-being and mental health.
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- Body composition and anthropometric variables.
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- Sleep quality, overall quality of life, and cancer-related quality of life.
All these objectives respond to three main priorities in current oncology:
- to understand the physiological and molecular mechanisms underlying the therapeutic effects of exercise.
- to generate robust evidence in highly vulnerable and underrepresented populations, such as hematologic cancer patients.
- to establish the basis for incorporating strength training as a standardized adjuvant intervention within the clinical management of cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusión criteria:
- •Adult patients (≥18 years), capable of signing the informed consent and willing to participate in the study.
- •Performance status (ECOG) 0-
- •Specific inclusion criteria are defined for each cohort involved in the study as follows:
- •Lung cancer: Patients diagnosed with non-small cell lung carcinoma in metastatic stage, eligible for combined immunotherapy and chemotherapy, with active treatment.
- •Colorectal cancer: Patients with stage II, III, or IV resected colorectal cancer undergoing adjuvant chemotherapy.
- •Breast cancer: Female patients with histologically confirmed hormone receptor-positive/HER2-negative breast cancer, receiving active hormonal therapy (tamoxifen, aromatase inhibitor, or fulvestrant) in either adjuvant or stable metastatic phase.
- •Chronic lymphocytic leukemia (CLL): Patients diagnosed with CLL who have not received and are not in need of pharmacological treatment.
- •Multiple myeloma (MM): Patients with a confirmed new diagnosis of MM under active first line treatment and non-candidates to autologous transplantation.
排除标准
- •Presence of unstable bone metastases or extensive bone involvement associated with a high risk of fracture.
- •Uncontrolled cardiovascular, respiratory, musculoskeletal, or metabolic diseases that contraindicate physical exercise at the investigator's discretion.
- •Explicit medical contraindication to exercise training.
- •Documented poor adherence (<80%).
- •Treatment discontinuation, disease progression, intolerance, or any other medical, personal, or logistical circumstance that, in the opinion of the investigators, may compromise participant safety or the integrity of the study.
结局指标
主要结局
Functional physical condition
时间窗: 36 months
Dynamometry and Short Physical Performance Battery scale
次要结局
- Psychological well-being and mental health(36 months)
- Determination of body composition(36 months)
- Sleep quality(36 months)
- Overall Quality of life(36 months)
- Genomics profiling(36 months)
- Proteomics profiling(36 months)
- Multi-Omics data integration for comprehensive physiological analysis(36 months)
研究者
CARLOS MARTIN SANCHEZ
PhD
University of Salamanca