Neurotoxic phenomena are among the most common and difficult to treat side effects of chemotherapy. The development of chemotherapy induced peripheral neuropathy (CIPN) is a well-recognized adverse reaction in the peripheral nervous system. Side effects of chemotherapy in the central nervous system, however, particularly changes of cognitive function (in non-medical literature referred to as "chemobrain") are diffuse and difficult to attribute to individual cytostatic drugs. The primary purpose of this study is to assess cognitive function in patients with ovarian and breast cancer before and after systemic chemotherapy with paclitaxel with standardized neuropsychological tests and compare the outcome to patients with benign gynecological tumors and breast cancer without chemotherapy treatment, respectively. Secondary parameters include the assessment of olfactory function, total neuropathy score and cytokine profiles.
Primary outcome parameter: compound score of standardized neuropsychological test Secondary parameters: * olfactory function (Sniffin Sticks) * total neuropathy score (TNS), reduced version (clinical examination, neurography of sural and peroneal nerve) * cytokine profiling from serum samples (ELISA) * quality of life (questionnaire) * depression screening (questionnaire) * symptoms of polyneuropathy (questionnaire) * symptoms of cognitive impairment (everyday memory test questionnaire) Assessment time points: * baseline (after surgical tumor resection and before chemotherapy) * follow up 1 (3 weeks after last chemotherapy cycle or 21 weeks (control patients)) * follow up 2 (optional; 1 year after chemotherapy completion)
Study Type
OBSERVATIONAL
Enrollment
72
standard combination chemotherapy (paclitaxel +/- carboplatin) if necessary according to treatment guidelines
Charité Universitätsmedizin Berlin
Berlin, Germany
Change from baseline compound score of standardized neuropsychological test
standardized neuropsychological test covering verbal memory, visual-spatial memory, short term/ working memory, executive functions
Time frame: 3 weeks after last chemotherapy cycle (21 weeks)
Change from baseline olfactory function
standardized test battery (Sniffin Sticks)
Time frame: 3 weeks after last chemotherapy cycle (21 weeks)
Change from baseline total neuropathy score (TNSr)
reduced version includes clinical examination and neurography of sural and peroneal nerve
Time frame: 3 weeks after last chemotherapy cycle (21 weeks)
Change from baseline cytokine profiling (serum sample)
ELISA of serum samples
Time frame: 3 weeks after last chemotherapy cycle (21 weeks)
Change from baseline quality of life questionnaire
EORTC-QLQ-C30
Time frame: 3 weeks after last chemotherapy cycle (21 weeks)
Change from baseline depression screening questionnaire
DESC-I
Time frame: 3 weeks after last chemotherapy cycle (21 weeks)
Change from baseline symptoms of polyneuropathy questionnaire
EORTC-QLQ-C30+CIPN20
Time frame: 3 weeks after last chemotherapy cycle (21 weeks)
Change from baseline symptoms of cognitive decline (questionnaire)
everyday memory test
Time frame: 3 weeks after last chemotherapy cycle (21 weeks)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.