The influence of immunotherapy and chemotherapy accompanying endurance training on incidence and severity of cognitive deficits as well as other therapy-induced side effects and complications in oncological patients. A randomized controlled trial

Not Applicable

• Conditions: DIVERSE; C00-C75; Malignant neoplasms, stated or presumed to be primary, of specified sites, except of lymphoid, haematopoietic and related tissue

• Registration Number: DRKS00011390
• Lead Sponsor: niversitäres Centrum für Tumorerkrankungen (UCT) FrankfurtKrankenhaus NordwestKlinik für Onkologie und Hämatologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 2

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

• 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.