C50 C51-C58
Conditions
Interventions
Group 1: In order to investigate the influence of different medical treatments on cognitive abilities longitudinally, patients with breast cancer or gynecological tumors are cognitively tested at 3 me
Sponsors
Deutsches Krebsforschungszentrum (DKFZ)
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion criteria for patients - Female - Age = 18 years - Diagnosis of breast cancer or gynecological tumor - Before the start of a first-line therapy from the following categories: o Chemotherapy o Radiotherapy o Hormone therapy o Immunotherapy Inclusion criteria for healthy control group (n=30) - Female - Age = 18 years - native speaker
Exclusion criteria
Exclusion criteria: Exclusion criteria for patients and healthy control group: - Previous, known or treated tumor disease - Known neurodegenerative diseases (e.g. MS, Alzheimer's, Huntington's) - Known psychological diseases - Known neurological damage (e.g. epilepsy, apoplexy) - thyroid disorders - Medication that has a proven effect on cognitive performance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The influence of different first-line medical therapies on verbal memory performance of gynecological cancer patients. Verbal memory performance is enhanced by the Hopkins Verbal Learning Test - Revised (HVLT-R), whereby the variable "Total Recall" is defined as the primary target parameter. The endpoints mentioned will be recorded at three measurement times: - Before starting the first-line therapy (T1) - 7-14 days after completion of first-line therapy, with a maximum of 6 months after completing the first-line therapy (T2) - One year after T2 (T3) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Influence of different first-line medical therapies on other objectively measured cognitive domains o attention: Trail Making Test (TMT) A o cognitive flexibility: TMT B o visual differentiation capability: Visual Pattern Separation Task - Influence of first-line medical therapy on the subjective cognitive performance, measured using the FACTcog - Influence of first-line medical therapy on systemic inflammatory status and the peripheral concentration of neurotrophic factors. For the detection of peripheral inflammation markers and the concentration of neurotrophic factors, 9 ml of venous blood is taken from the study participants and archived as serum at -80 °C. The analyses are performed in the NCT (Nationales Centrum für Tumorerkrankungen) after completion of the last patient examination using Enzyme-Linked ImmunoSorbent Assay (ELISA). Currently planned target parameters are Interleukin-6, Interleukin-1, Receptor antagonist, brain-derived neurotrophic factor, tryptophan, kynurenine, kynurenic acid and quinolinic acid. The final selection of the parameters takes place before starting with the analysis on the basis of the current literature. | — |
Countries
Germany
Contacts
Public ContactPhilipp Zimmer
Abteilung Bewegung, ?Präventionsforschung und ?Krebs (G210) Deutsches ?Krebsforschungszentrum ?(DKFZ) und Nationales Centrum für Tumorerkrankungen (NCT)
Outcome results
None listed