Cognition Disorders, Polyneuropathies
Conditions
Keywords
cognition, chemotherapy, polyneuropathy, paclitaxel, cancer, chemobrain
Brief summary
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.
Detailed description
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)
Interventions
DRUGChemotherapy
standard combination chemotherapy (paclitaxel +/- carboplatin) if necessary according to treatment guidelines
Sponsors
Charite University, Berlin, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* age * written informed consent * Karnofsky index \>70% / ECOG \<1 * at least 8 years of education
Exclusion criteria
* post surgical delirium * major depression * alcohol or drug abuse * anemia \< 8 g/dl * mild cognitive impairment or dementia * previous neurotoxic chemotherapy treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline compound score of standardized neuropsychological test | 3 weeks after last chemotherapy cycle (21 weeks) | standardized neuropsychological test covering verbal memory, visual-spatial memory, short term/ working memory, executive functions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline total neuropathy score (TNSr) | 3 weeks after last chemotherapy cycle (21 weeks) | reduced version includes clinical examination and neurography of sural and peroneal nerve |
| Change from baseline cytokine profiling (serum sample) | 3 weeks after last chemotherapy cycle (21 weeks) | ELISA of serum samples |
| Change from baseline quality of life questionnaire | 3 weeks after last chemotherapy cycle (21 weeks) | EORTC-QLQ-C30 |
| Change from baseline olfactory function | 3 weeks after last chemotherapy cycle (21 weeks) | standardized test battery (Sniffin Sticks) |
| Change from baseline symptoms of polyneuropathy questionnaire | 3 weeks after last chemotherapy cycle (21 weeks) | EORTC-QLQ-C30+CIPN20 |
| Change from baseline symptoms of cognitive decline (questionnaire) | 3 weeks after last chemotherapy cycle (21 weeks) | everyday memory test |
| Change from baseline depression screening questionnaire | 3 weeks after last chemotherapy cycle (21 weeks) | DESC-I |
Countries
Germany
Outcome results
None listed