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临床试验/NCT07267000
NCT07267000招募中不适用

EXERCISE AND THE IMMUNE RESPONSE IN LUNG CANCER

Medical University of Graz2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
2
主要终点
Response to immunotherapy

研究概览

简要总结

This project is about the effect of a 12-week training therapy intervention in patients suffering from non-small cell and small-cell lung cancer. It has widely been accepted that exercise is preventive against certain types of cancer. Individuals following an active lifestyle have a significantly lower risk for several chronic diseases, including cancer, as compared to sedentary ones. However, evidence is still lacking for exercise as part of routine cancer treatment. It has widely been accepted that exercise strongly impacts immune response, and might influence antitumor immune response as well. In this study, patients suffering from lung cancer undergo either a 12-week training program consisting of moderate-intensity continuous exercise (MICE), or a 12-week program with high-intensity interval exercise. Both groups will be compared to a control group receiving standard exercise recommendations. The immunologic response, i.e. cytokine profiles and changes in peripheral blood mononuclear cell (PBMC) characteristics will be the main endpoint. Blood will be taken from the patients at different timepoints, and blood samples will be tested for these immunologic changes. FACS analysis will be used to assess the properties of immune cells and potential changes upon the exercise regimen. Mitochondrial function will be assessed via the Seahorse machine, and mass spectrometry (lipidomics) will be used for the analysis of lipid profile changes.

详细描述

Lung cancer is the number one cause of cancer-related deaths worldwide. A few decades ago, the prognosis at lung cancer first diagnosis was generally poor with only a few months of median survival. New treatment regimens have markedly improved survival times - especially in certain histologic and molecular pathologic subtypes. The positive effect of exercise on the incidence of several cancer entities such as colorectal- or breast cancer, has been demonstrated previously. Physically active individuals are diagnosed with cancer significantly less often as compared to sedentary people. In oncologic follow-up care, a positive effect of exercise and training with an advantage in survival has also been proven, e.g. in breast cancer patients.

In addition, existing data shows a positive effect of exercise on the immune system: active individuals show a different pattern of proinflammatory markers in the blood serum, with every exercise session generating an immune-stimulatory effect which changes the immunologic serum profile also at rest. Thus, regular exercise has an anti-inflammatory long-term effect.

Hypothesis and Objectives: With this project the investigators seek to demonstrate distinct immunologic changes, assessing cytokine serum profiles and changes in peripheral blood mononuclear cell (PBMC) characteristics upon a medically guided training regimen. The investigators assume that the antitumor immune response is positively affected by the training therapy regimen.

Setting and Methods. To exactly define "exercise" in this setting, as a first step the investigators will test two exercise types in healthy individuals. According to the individual exercise capacity as determined by spiroergometry, healthy subjects will either perform moderate-intensity continuous exercise (MICE), or a high-intensity interval training (HIIT). By means of venous blood sampling before and after training the investigators determine the respective changes of serum immune markers through exercise. The same two training types will then be performed by lung cancer patients upon immunotherapy, with one patient group doing MICE-sessions, one group doing the HIIT and a third group who will receive general exercise recommendations but otherwise will not undergo supervised training. Inflammatory serum parameters and PBMC characteristics will be compared between the groups. Moreover, the overall aerobic capacity (and respective changes before and after the training intervention), as well as quality of life will be analysed.

Patients in the exercise groups will be advised to train once a week under medical supervision, and to walk briskly for 30 minutes every day of the week in addition. The investigators' hypothesis is, that exercise should be implemented as a complementary treatment strategy in the lung cancer treatment setting, possibly improving not only physical health and wellbeing but also treatment response. In addition to improving the patients' quality of life by a better physical capacity and fitness, helping the participants in everyday activities, the investigators propose that the implementation of exercise programs in various oncologic settings in future may improve the patients' outcome.

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
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients suffering from non-small cell or small-cell lung cancer of any histologic subtype, irrespective of routine treatment regimen
  • ECOG 0 or 1

排除标准

  • Kachexia (BMI<18.5)
  • instable bone metastases
  • orthopedic condition rendering the patient unable to ride a stationary bike
  • any medical contraindication for exercise and training
  • a living will against basic or advanced life support

研究组 & 干预措施

Continuous Exercise

Experimental

Patients in this arm will undergo a 12-week training therapy regimen consisting of twice weekly supervised moderate-intensity continuous exercise (MICE) and home-based walking exercise for 30 minutes, five times a week, in addition.

干预措施: Exercise (Behavioral)

Controls

Active Comparator

Patients in this arm will receive general recommendations on an active lifestyle, but will not take part in supervised training sessions and are not asked to do home-based exercise either.

干预措施: Control (Other)

High Intensity Interval Exercise

Experimental

Patients in this arm will undergo a 12-week training therapy regimen consisting of twice weekly supervised high-intensity interval exercise and home-based walking exercise for 30 minutes, five times a week, in addition.

干预措施: Exercise (Behavioral)

结局指标

主要结局

Response to immunotherapy

时间窗: From enrollment to the first CT scan after the 12 week training therapy intervention

Response to immunotherapy will be measured on the one hand metrically based on the change of tumor volume in mm3, and on the other hand based on the RECIST criteria.

次要结局

  • Immunologic changes - FACS analysis(From enrollment to after completion of the 12 week training therapy intervention)
  • Seahorse analysis(From enrollment to after completion of the exercise intervention)
  • Mass spectrometry - Lipidomics(From enrollment to after completion of the 12 week exercise intervention.)
  • Cytokine profiling(From enrollment to after completion of the 12 week training therapy intervention.)

研究者

发起方
Medical University of Graz
申办方类型
Other
责任方
Sponsor

研究点 (2)

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