Trial document




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  DRKS00008531

Trial Description

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Title

Influence of acute physical activity on the NK-cell cytotoxicity of esophageal cancer patients

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Former investigations give first hints that physical activity has a positive influence on the development of several cancer types, cancer-related mortality as well as cancer recurence. The way physical activity promotes these influences is not understood yet. As a possible mechanism a sports related activation of the body owns cancer defense by natural killer cells is discussed. Natural killer cells belong to the immune system and have the ability to recognize and kill cancer cells.
This study should investigate, if a single bout of aerobic exercise could improve the ability of natural killer cells to kill cancer cells and promote a migration of natural killer cells into the tumor tissue of esophageal cancer patients (This study is an amendment of the study DRKS00005037). Therefore, 24 esophageal carcinoma patients should be included before surgical tumor removal. Patients will be randomized in an intervention and a control group. The intervention group performs an intensive bout of aerobic exercise 10-14 hours before tumor removal. The control group stays in rest during the same time interval. Before, after and 12 hours after the bout of exercise or rest blood is drawn. The blood samples are used for isolation of natural killer cells and analyzing of tumor cell killing. Further the natural killer cells will be characterized in respect for subgroups. After the tumor removal the tissue is investigated for intratumoral natural killer cells.
With these investigations it should be shown if a single bout of aerobic exercise could improve the ability of natural killer cells to kill tumor cells and if it could promote a migration of natural killer cells into the tumor tissue.

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Brief Summary in Scientific Language

The literature shows a positive influence of physical activity on cancer specific mortality. Furthermore, physical activity could improve the risk for primary cancers and relapses. The knowledge about the underlying mechanisms is still sparse. An exercise induced activation of the body owns cancer defense by natural killer cells is discussed as one such mechanism. Therefore, this study investigates the influence of a single bout of aerobic exercise on natural killer cell cytotoxcity and the tumorinfiltration by natural killer cells (Amendment of the study DRKS00005037).
For this purpose 24 esophageal cancer patients before surgical tumor resection and without neoadjuvant therapy should be included. Patients will be randomized into an intervention and a control group. The intervention group will perform a single bout of aerobic exercise on a bicycle ergometer 10-14 hours before tumor resection. In the same time interval, the control group will stay in rest. Before, after and 12 hours after exercise or rest blood will be drawn. Natural killer cells will be isolated from the blood samples and the cytotoxicity will be measured. Additionally, a characterization of natural killer cells in respect to their subsets will be done. Finally, the removed tumor tissue will be analyzed for intratumoral natural killer cells.
With these analyses it will be shown, if a single bout of aerobic exercise can influence the natural killer cell cytotoxicity and the migration into the tumor tissue.

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Organizational Data

  •   DRKS00008531
  •   2015/06/17
  •   [---]*
  •   yes
  •   Approved
  •   13-050, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   Esophageal carcinoma
  •   C15 -  Malignant neoplasm of oesophagus
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Interventions/Observational Groups

  •   Interventiongroup: The interventiongroup will have a single bout of aerobic exercise about 12 h befor tumorresection. The will performe a step-protocoll on a bycicle-ergometer. Load starts at 20 watt and will be increased every 3 minutes with 10 watts. With that protocoll a long duration and a high intensity will be ensured.
  •   Controlgroup: The controlgroup will not perform any exercise. They will stay in rest for 30 minutes at least 12 hours befor tumorresection.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Control group receives no treatment
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Primary outcome is the nk-cell-cytotoxicity. Before, after and 12 h after the single bout of exercise blood will be drawn. From this blood samples nk-cells will be isolated and used in cytotoxicity assays with the cell line K562 as target cell.

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Secondary Outcome

Secondary edpoints are the characterization of NK-cells and the tumorinfiltration by NK-cells.
For the characterization blood will be drawn (befor, after and 12 h after exercise) and the NK-cells will be investigated for their subgroups (CD56bright and CD56dim) and for the degranulation marker CD107a by flow cytometry.
The tumor tissue will be removed and analysed for NK-cell infiltration by imunohistochemistry. Therefore the NK-cells will be stained by CD56 and CD57.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/10/06
  •   24
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Esophageal carcinoma, befor Operation (tumoe removal), medical innocuousness for the sport intervention

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Exclusion Criteria

Age < 18 years, therapy befor operatione (chemotherapy or radiation), medical contraindications for exercise

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Addresses

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    • Deutsche Sporthochschule Köln, Institut für Kreislaufforschung und Sportmedizin, Abteilung für molekulare und zelluläre Sportmedizin
    • Mr.  Prof. Dr.  Wilhelm  Bloch 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    • Deutsche Sporthochschule Köln, Institut für Kreislaufforschung und Sportmedizin, Abteilung für molekulare und zelluläre Sprotmedizin
    • Mr.  Alexander  Schenk 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    • Deutsche Sporthochschule Köln, Institut für Kreislaufforschung und Sportmedizin, Abteilung für molekulare und zelluläre Sprotmedizin
    • Mr.  Alexander  Schenk 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Sporthochschule Köln, Institut für Kreislaufforschung und Sportmedizin, Abteilung für molekulare und zelluläre Sportmedizin
    • Mr.  Prof. Dr.  Wilhelm  Bloch 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    • Deutsche Sporthochschule Köln, Institut für Kreislaufforschung und SPortmedizin, Abteilung für molekulare und zelluläre Sportmedizin
    • Mr.  PD. Dr.  Freerk T.  Baumann 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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Status

  •   Recruiting stopped after recruiting started
  •   2018/12/31
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.