Cognitive function in patients with gynecological tumors
Organizational Data
- DRKS-ID:
- DRKS00015757
- Recruitment Status:
- Recruiting planned
- Date of registration in DRKS:
- 2018-10-29
- Last update in DRKS:
- 2018-10-29
- Registration type:
- Prospective
Acronym/abbreviation of the study
COGNIFiT
URL of the study
No Entry
Brief summary in lay language
Cancer patients often suffer from tiredness and listlessness, which can strongly influence the general quality of life. This syndrome, also called fatigue, can cause limitations in physical, emotional and mental areas of daily life. Physical activity and sleep patterns can also be affected by medical treatment. In addition, during and after medical cancer treatments, patients repeatedly report a loss of brain performance (e.g. concentration, memory). The scientific data on this phenomenon is contradictory and there are differences between the experienced and the measurable losses. On this basis, the COGNIFit study is intended to gain more comprehensive knowledge to better understand the influence of various therapies and other influencing variables on cognitive functions (brain performance) and to create a basis for implementing these findings in everyday medical practice in the long term. Approximately 200 cancer patients will participate in this study over a period of three years.
Brief summary in scientific language
Up to 80% of all cancer patients complain about cognitive impairments during medical treatment, known under the term "chemobrain". About 35% of all patients still describe cognitive deficits even years after the end of treatment, mainly manifesting in memory and concentration deficits, which do not only make returning to work difficult but ultimately reduce the quality of life of those affected. Despite the great relevance of the topic, little is known about the exact causes and mechanisms so far. Although studies have shown structural changes of the brain after various types of medical treatment, there is a blatant discrepancy between subjectively and objectively measured cognitive impairments. It is also unclear whether cognitive impairments are exclusively caused by medical treatment or whether it is also influenced by psycho-social factors (anxiety, depression, fatigue, sleep disorders, physical activity). Due to the use of both heterogeneous objective and subjective cognitive measures as well as an inadequate recording of influencing factors and biological mediators the informative value of the studies conducted so far is limited. Against this background, the COGNIFiT study will include an objective measurement of cognitive functions as recommended by the International Cancer and Cognition Task Force (ICCTF) in combination with an established questionnaire on subjectively perceived cognitive performance. Furthermore, potential biological and psycho-social influencing factors before and after drug therapy (especially chemo- and hormone therapy) in patients with different gynecological tumor types will be investigated. In addition, a subgroup of patients with immunotherapy will be examined for the first time. Over a period of 36 months, 200 patients at the NCT will undergo this assessment, which can be easily integrated into the medical routine. The results of the study will not only provide information on the severity of cognitive impairments but also on their causes and mechanisms. They will form the basis for effective preventive and supportive therapy measures at the NCT and may also have an impact on patients' fear of cognitive deficits.
Health condition or problem studied
- ICD10:
- C50 - Malignant neoplasm of breast
- ICD10:
- C51-C58 - Malignant neoplasms of female genital organs
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 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 measurement points (before the start of first-line therapy, after completion of first-line therapy (T2) and one year after T2) using the HVLT-R (Hopkins Verbal Learning Test–Revised), TMT A/B (Trail Making Test A and B) and the Pattern Separation Task. In addition, subjective parameters and data on mediator variables (movement questionnaire, FACT-cog, CES-D, EORTC-FA12, VAS, PSQI, return to work) are recorded at all measurement times.
- Arm 2:
- In addition to the patients, data will be collected in a healthy control group (n=30) in order to classify the patient data according to their clinical relevance.
Endpoints
- Primary outcome:
- 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 outcome:
- - 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.
Study Design
- Purpose:
- Supportive care
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting planned
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Medical center Nationales Centrum für Tumorerkrankungen Heidelberg
Recruitment period and number of participants
- Planned study start date:
- 2018-11-12
- Actual study start date:
- No Entry
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 200
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- Female
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional 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 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
Addresses
Primary Sponsor
- Address:
- Deutsches Krebsforschungszentrum (DKFZ)Prof. Dr. Karen SteindorfIm Neuenheimer Feld 28069120 HeidelbergGermany
- Telephone:
- +49 6221 56 5838
- Fax:
- +49 6221 56 5231
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.dkfz.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Abteilung Bewegung, Präventionsforschung und Krebs (G210) Deutsches Krebsforschungszentrum (DKFZ) und Nationales Centrum für Tumorerkrankungen (NCT)Dr. Dr. Philipp ZimmerIm Neuenheimer Feld 58169120 HeidelbergGermany
- Telephone:
- +49 6221 42-2220
- Fax:
- +49 6221 42-2229
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.dkfz.de
Contact for Public Queries
- Address:
- Abteilung Bewegung, Präventionsforschung und Krebs (G210) Deutsches Krebsforschungszentrum (DKFZ) und Nationales Centrum für Tumorerkrankungen (NCT)Dr. Dr. Philipp ZimmerIm Neuenheimer Feld 58169120 HeidelbergGermany
- Telephone:
- +49 6221 42-2220
- Fax:
- +49 6221 42-2229
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.dkfz.de
Principal Investigator
- Address:
- Abteilung Bewegung, Präventionsforschung und Krebs (G210) Deutsches Krebsforschungszentrum (DKFZ) und Nationales Centrum für Tumorerkrankungen (NCT)Dr. Dr. Philipp ZimmerIm Neuenheimer Feld 58169120 HeidelbergGermany
- Telephone:
- +49 6221 42-2220
- Fax:
- +49 6221 42-2229
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.dkfz.de
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Deutsches Krebsforschungszentrum (DKFZ)Im Neuenheimer Feld 28069120 HeidelbergGermany
- Telephone:
- +49 6221 56 5838
- Fax:
- +49 6221 56 5231
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.dkfz.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Medizinischen Fakultät HeidelbergAlte Glockengießerei 11/169115 HeidelbergGermany
- Telephone:
- +49-6221-338220
- Fax:
- +49-6221-3382222
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2018-07-20
- Ethics committee number:
- S-489/2018
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2018-09-17
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry