DIVERSE C00-C75
Conditions
Interventions
Group 1: Exercise Group: In addition to primary care via physiotherapists, patients alocated to this group will receive 30-35 minutes of a supervised high intensity training on a stationary bicycle er
Sponsors
Universitäres Centrum für Tumorerkrankungen (UCT) FrankfurtKrankenhaus NordwestKlinik für Onkologie und Hämatologie
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: • Entities: Bronchial Carcinoma (NSCLC), Bladder Carcinoma, Malignant Melanoma, Renal Cell Carcinoma, Gastrointestinal Tumors, Triple-negative Mamma CA • PD-1, PD-L1, CTLA4 Receptor + • Upcoming first or second-line therapy (t0 before therapy)
Exclusion criteria
Exclusion criteria: • Comorbidities that prevent participation in exercise intervention (e.g. CHD, Heart failure NYHA>3, orthopedic disorders, cerebral spasms, psychological diseases that do not allow intervention from the point of view of the study physician) • Upcoming, planned surgery in intervention period • Formation of metastases in the central nervous system or osseous with danger of stability • A medical or mental condition which, in the opinion of the investigator, does not permit the patient to participate in the study or to provide a legally valid signature on the informed consent form. • Presence of cognitive impairments of other causes (e.g. dementia, multiple sclerosis, condition after apoplexy/skull-brain trauma, condition after brain tumor) unwillingness to store and share personal medical data under the Protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary measurement is the patients outcome in several neuropsychological tests as recommended by the ICCTF, The test battery will include the Trail Making Test (TMT: selective attention, set shifting), German versions of the Hopkins Verbal Learning Test Revised (HVLT-R: verbal learning and memory) and the Controlled Oral Word Association Test (COWAT/RWT: verbal fluency). In addition, a classical Go/No-go paradigm will be used to measure executive functioning subdomain response inhibition. Measurements will take place at three points (before first immunotherapy, shortly after intervention (week 13) and 6 months after the end of intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjective perceived impairment of cognitive performance --> FACT-COG Functional Assessment of Cancer Therapy - Cognitive Function ( Version 3) and FEDA questionnaire of Experienced Deficits of Attention Psychological stress of patients --> Hospital Anxiety and Depression Scale Patients`fatigue --> Multidimensional Fatigue Inventory - 20 Items questionnaire Sleep Quality --> Pittsburgh Sleeping Quality Index (PSQI) Level of activity: Physical Activity Questionnaire (KAS, DSHS-Cologne) Performance Status --> Classification of the Eastern Cooperative Oncology Group (ECOG Performance Status) Vocabulary intelligence test --> MWT-B Physical performance of patients --> spiroergometric performance The quality of life of patients --> EORTC QLQ-C30 questionnaires Determination of immune status and periphere neurotrophic factors of patients --> analyse relevant blood parameters (BDNF, VEGF, IGF-1), blood serum pro. (TNF-a, CRP) and anti-inflammatory cytokines (IL-1, IL-10). The analysis will be realised by using enzyme-linked immunosorbent assays (ELISAs). Measurements will take place at three points (before first immunotherapy, shortly after intervention (week 13) and 6 months after the end of intervention. | — |
Countries
Germany
Contacts
Public ContactNils Schaffrath
Universitäres Centrum für Tumorerkrankungen (UCT) FrankfurtKrankenhaus NordwestKlinik für Onkologie und Hämatologie
Outcome results
None listed