NCT04676009已完成不适用
Feasibility of an Acute Physical Exercise Before Immunotherapy and Chemotherapy Infusion for Metastatic Non-small-cell Lung Cancer Patients: Protocol ERICA Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Investigate the feasibility of an acute physical exercise during the immunotherapy/chemotherapy preinfusion
研究概览
简要总结
Because of metastatic Non-Small Cell Lung Cancer (mNSCLC) and its treatments, patients suffer from numerous symptoms such as dyspnea, muscle atrophy, pain, fatigue, loss of appetite, altered physical condition and lung function, which may further impair the patient's overall condition. Nevertheless, it has been suggested that physical exercise could improve response to treatment at the clinical level due to its known effects on the immune system. Moreover, preclinical studies have shown that exercise performed during chemotherapy administration could result in physiological benefits such as improved intra-tumoral infusion and drug delivery. The ERICA study aims to assess the feasibility of an acute physical exercise immediately before immunotherapy and chemotherapy administration in patients with mNSCLC.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years old,
- •Having a newly metastatic non-small-cell lung cancer (NSCLC) without an EGFR/ALK alteration diagnosis,
- •Being scheduled to receive a 1st line intravenous chemotherapy (Cisplatin and Pemetrexed or Carboplatin and Pemetrexed or Taxol and Carboplatin), and immunotherapy (monoclonal anti-PD-1 and anti-PD-L1 antibodies : Pembrolizumab) treatment NB : patients who have previously received one or more treatments other than chemotherapy (e.g. targeted therapy) and must start their first chemotherapy are eligible,
- •Treated in Centre Leon Berard,
- •Having an Eastern Co-operative Oncology Group (ECOG) performance status ≤ 2,
- •Being voluntary and available to get involved throughout the study duration,
- •Being able to engage in Physical Activity with a medical certificate attested by one of the investigators clinical oncologist or the referring oncologist,
- •Affiliated with a social security scheme,
- •Having dated and signed an informed consent.
- •Able to read, write and understand French
排除标准
- •Patient with unstable bone metastases or unconsolidated pathologic fractures, Having a central nervous system impairment with neurological disorder avoids the physical exercise practice on a cycle ergometry,
- •Personal history or co-existence of another primary cancer (except of in situ cancer regardless of the site and/or basal cell skin cancer and/or cancer in complete remission for more than 5 years),
- •Having severe undernutrition defined according to the Haute Autorité de Santé (i.e. , for an adult aged ≥18 years and < 70 : BIM ≤ 17 or weight loss ≥ 10% in 1 month or ≥15% in 6 months or ≥ 15% compared to the usual weight before the disease diagnosis or albuminemia < 30 g/l ; for an adult aged ≥70 years : BIM < 18 or weight loss ≥ 10% in 1 month or ≥15% in 6 months or an albuminemia < 30 g/l),
- •Having a severe amenia (hemoglobin ≤ 8 g/dl) during the 30 last days prior inclusion,
- •Presenting cardiovascular history or any cardiovascular risk: chronic coronary (or poorly balanced), artery disease, cardiac arrhythmia, symptomatic heart disease, uncontrolled or untreated hypertension, heart attack diagnosed within the last 6 months, coronary angioplasty with or without stent less than 6 months old, coronary artery bypass surgery less than 12 months old, history of poorly balanced type 2 diabetes,
- •In case of diabetes: Glycated hemoglobin (HbA1c) > 7% (in the last 3 months),
- •Stage IV Chronic Obstructive Pulmonary Disease (FEV1 < 30%),
- •Patient with a contraindication to the proposed physical exercise in the study (orthopedic disorder likely to impede walking and pedaling such as disabling coxarthrosis or gonarthrosis, operated or not),
- •Already included in a PA study,
- •Cannot be followed for medical, social, family, geographical or psychological reasons, for the duration of the intervention (3 months) and then for the duration of the post-intervention follow-up (3 months),
- •Patient under legal protection measure (under guardianship, curatorship, safeguard of justice),
- •Deprived of liberty by judicial or administrative decision,
- •Pregnant patient.
结局指标
主要结局
Investigate the feasibility of an acute physical exercise during the immunotherapy/chemotherapy preinfusion
时间窗: 3 months
Ratio of the number of acute physical exercise sessions immunotherapy/chemotherapy preinfusion performed by"exercise" group patient / number of acute physical exercise sessions planned
次要结局
- Investigate the muscle mass and sarcopenia(Baseline, 3 months, 6 months)
- Investigate the lower strength muscular function change(Baseline, 3 months, 6 months)
- Investigate the maximum isometric upper limb strength change(Baseline, 3 months, 6 months)
- Investigate the physical activity fitness (sub-maximum endurance test)(Baseline, 3 months)
- Investigate the patient health-related quality of life change(Baseline, 3 months, 6 months)
- Investigate the Physical Activity level change(Baseline, 3 months and 6 months)
- Investigate the IL-1béta change (inflammation biomarkers)(Baseline and 3 months)
- Investigate the IL-6 change (inflammation biomarkers)(Baseline and 3 months)
- Investigate the Myostatin change (inflammation biomarkers)(Baseline and 3 months)
- Investigate the malondialdehyde (MDA) change(Baseline and 3 months)
- Investigate the patient health-related quality of life specific to lung cancer change(Baseline, 3 months, 6 months)
- Investigate the fatigue change(Baseline, 3 months, 6 months)
- Investigate the Follistatin (inflammation biomarkers)(Baseline and 3 months)
- Investigate the sleep quality change(Baseline, 3 months, 6 months)
- Investigate the impact of social vulnerability(Baseline)
- Investigate the immune biomarkers change(Baseline and 3 months)
- Investigate the GDF15 (inflammation biomarkers)(Baseline and 3 months)
- Investigate the TNF-alpha change (inflammation biomarkers)(Baseline and 3 months)
- Progression free survival(6 months)
- Safety of the intervention(3 months)
- Investigate the glucose change(Baseline and 3 months)
- Investigate the insulin change(Baseline and 3 months)
- Investigate the Activin change (inflammation biomarkers)(Baseline and 3 months)
- Investigate the NH3 (inflammation biomarkers)(Baseline and 3 months)
- Investigate the IFN-gamma change (inflammation biomarkers)(Baseline and 3 months)
- Investigate the glutathione peroxidase (GPX) change(Baseline and 3 months)
- Investigate the Xanthine Myeloperoxidase (MPO) change(Baseline and 3 months)
- Investigate the GDF5 (BMP14) (inflammation biomarkers)(Baseline and 3 months)
- Investigate the IL-10 (inflammation biomarkers)(Baseline and 3 months)
- Investigate the IL-15 (inflammation biomarkers)(Baseline and 3 months)
- Investigate the Aminogramme (inflammation biomarkers)(Baseline and 3 months)
- Investigate the Superoxide dismutase (SOD) change(Baseline and 3 months)
- Investigate the catalase (CAT) change(Baseline and 3 months)
- Investigate the CRP (inflammation biomarkers)(Baseline and 3 months)
- Investigate the Cortisol change (inflammation biomarkers)(Baseline and 3 months)
- Investigate the Advanced oxidation protein products (AOPP) change(Baseline and 3 months)
- Tracker activity acceptability(3 months)
- Investigate the lactat change(Baseline and 3 months)
- Investigate the PCR change(Baseline and 3 months)
- Investigate the Xanthine oxidase (XO) change(Baseline and 3 months)
- Proportion of patients who have severe toxicity (grade >2)(Up to 3 months)
- Acceptability of the study(3 months)
- Adherence of the intervention(3 months and 6 months)
- Investigate the HIF-1 change(Baseline and 3 months)
- Investigate the patient anthropometrics change(Baseline, 3 months, 6 months)
研究者
研究点 (2)
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