CogniFit study

Abstract

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 large discrepancy between subjectively and objectively measured cognitive impairments. It is also unclear whether cognitive impairments are exclusively caused by medical treatment or whether they are 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 objective measurements 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 cancer therapy in patients with different gynecological tumor types will be investigated.

Over a period of 36 months, 200 patients at the NCT will undergo these assessments. 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 and may also mitigate patients' fear of cognitive deficits.

Current status

Recruitment ended at the beginning of March 2022. The data are currently being evaluated.

Registration

Deutsches Register Klinischer Studien (DRKS00015757)

Publications

Assessment of Cancer-Related Cognitive Impairments Across Anti-Cancer Therapies in a Predominantly Breast Cancer Cohort (2026):  Lei, Q., Schmidt, M., Zimmer, P., Meyer, P., Schneeweiss, A., Steindorf, K.,  International journal of cancer; 10.1002/ijc.70691

The role of cognitive impairments in patients' return to work and quality of working life after treatment of breast or gynecologic cancer  (2025): Kias A, Schmidt ME, Steindorf K. Journal of Cancer Survivorship, https://doi.org/10.1007/s11764-025-01928-9

Subjective and Objective Cancer-Related Cognitive Impairments Among Systemic and Radiation Therapy-Naïve Female Cancer Patients (2025): Onyedibe MC, Schmidt ME, Bizer P, Zimmer P, Steindorf K Cancer Medicine, 14(8):e70908, 10.1002/cam4.70908