{
"info": {
"nct_id": "NCT03151291",
"official_title": "Effects of Physical Exercise in the Form of Whole-body Electromyostimulation (WB-EMS) Combined With Individualized Nutritional Therapy Using Specific Dietary Supplements on Cancer Patients Undergoing Curative or Palliative Anti-cancer Treatment",
"inclusion_criteria": "* malignant disease (solid or hematological cancer) e.g. head and neck cancer, colorectal carcinoma, small intestinal cancer, gastric cancer, oesophageal cancer, pancreas carcinoma, liver cell carcinoma, cholangiocarcinoma,lung cancer, breast cancer, cervix cancer, ovarian cancer, prostate cancer, renal cell carcinoma, malignant melanoma, patients with leukaemia and malignant lymphomas\n* ECOG Performance Status ≤ 2\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* simultaneous participation in other nutritional or exercise intervention trials\n* acute cardiovascular events\n* use of anabolic medications\n* epilepsy\n* severe neurological diseases\n* skin lesions in the area of electrodes\n* energy active metals in body\n* pregnancy\n* acute vein thrombosis",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* malignant disease (solid or hematological cancer) e.g. head and neck cancer, colorectal carcinoma, small intestinal cancer, gastric cancer, oesophageal cancer, pancreas carcinoma, liver cell carcinoma, cholangiocarcinoma,lung cancer, breast cancer, cervix cancer, ovarian cancer, prostate cancer, renal cell carcinoma, malignant melanoma, patients with leukaemia and malignant lymphomas",
"criterions": [
{
"exact_snippets": "malignant disease (solid or hematological cancer)",
"criterion": "malignant disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "head and neck cancer",
"criterion": "head and neck cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "colorectal carcinoma",
"criterion": "colorectal carcinoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "small intestinal cancer",
"criterion": "small intestinal cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "gastric cancer",
"criterion": "gastric cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "oesophageal cancer",
"criterion": "oesophageal cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "pancreas carcinoma",
"criterion": "pancreas carcinoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "liver cell carcinoma",
"criterion": "liver cell carcinoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "cholangiocarcinoma",
"criterion": "cholangiocarcinoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "lung cancer",
"criterion": "lung cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "breast cancer",
"criterion": "breast cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "cervix cancer",
"criterion": "cervix cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "ovarian cancer",
"criterion": "ovarian cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "prostate cancer",
"criterion": "prostate cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "renal cell carcinoma",
"criterion": "renal cell carcinoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "malignant melanoma",
"criterion": "malignant melanoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "patients with leukaemia",
"criterion": "leukaemia",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "malignant lymphomas",
"criterion": "malignant lymphomas",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* ECOG Performance Status ≤ 2",
"criterions": [
{
"exact_snippets": "ECOG Performance Status ≤ 2",
"criterion": "ECOG Performance Status",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* simultaneous participation in other nutritional or exercise intervention trials",
"criterions": [
{
"exact_snippets": "simultaneous participation in other nutritional or exercise intervention trials",
"criterion": "participation in other trials",
"requirements": [
{
"requirement_type": "type",
"expected_value": [
"nutritional intervention",
"exercise intervention"
]
},
{
"requirement_type": "simultaneity",
"expected_value": true
}
]
}
]
},
{
"line": "* acute cardiovascular events",
"criterions": [
{
"exact_snippets": "acute cardiovascular events",
"criterion": "acute cardiovascular events",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* use of anabolic medications",
"criterions": [
{
"exact_snippets": "use of anabolic medications",
"criterion": "anabolic medications",
"requirements": [
{
"requirement_type": "use",
"expected_value": true
}
]
}
]
},
{
"line": "* epilepsy",
"criterions": [
{
"exact_snippets": "epilepsy",
"criterion": "epilepsy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* severe neurological diseases",
"criterions": [
{
"exact_snippets": "severe neurological diseases",
"criterion": "neurological diseases",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "severe"
}
]
}
]
},
{
"line": "* skin lesions in the area of electrodes",
"criterions": [
{
"exact_snippets": "skin lesions in the area of electrodes",
"criterion": "skin lesions",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* energy active metals in body",
"criterions": [
{
"exact_snippets": "energy active metals in body",
"criterion": "energy active metals",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* pregnancy",
"criterions": [
{
"exact_snippets": "pregnancy",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* acute vein thrombosis",
"criterions": [
{
"exact_snippets": "acute vein thrombosis",
"criterion": "acute vein thrombosis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}