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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:
Assessment time points:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy | patients with ovarian cancer and paclitaxel + carboplatin combination chemotherapy as well as patients with breast cancer and paclitaxel +/- carboplatin combination chemotherapy |
| |
| Healthy control | patients with benign gynecological tumors after laparoscopic surgical resection | ||
| Tumor control | patients with breast cancer with anti-hormonal and/or localized radiation treatment but no chemotherapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy | Drug | standard combination chemotherapy (paclitaxel +/- carboplatin) if necessary according to treatment guidelines |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline compound score of standardized neuropsychological test | standardized neuropsychological test covering verbal memory, visual-spatial memory, short term/ working memory, executive functions | 3 weeks after last chemotherapy cycle (21 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline olfactory function | standardized test battery (Sniffin Sticks) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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primary care clinic, department of gynecology
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| Name | Affiliation | Role |
|---|---|---|
| Petra Huehnchen, Dr. | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Universitätsmedizin Berlin | Berlin | 10117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35133982 | Derived | Huehnchen P, Schinke C, Bangemann N, Dordevic AD, Kern J, Maierhof SK, Hew L, Nolte L, Kortvelyessy P, Gopfert JC, Ruprecht K, Somps CJ, Blohmer JU, Sehouli J, Endres M, Boehmerle W. Neurofilament proteins as a potential biomarker in chemotherapy-induced polyneuropathy. JCI Insight. 2022 Mar 22;7(6):e154395. doi: 10.1172/jci.insight.154395. |
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| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D011115 | Polyneuropathies |
| D009369 | Neoplasms |
| D000084202 | Chemotherapy-Related Cognitive Impairment |
| ID | Term |
|---|---|
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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serum samples, PBMC
| 3 weeks after last chemotherapy cycle (21 weeks) |
| Change from baseline cytokine profiling (serum sample) | ELISA of serum samples | 3 weeks after last chemotherapy cycle (21 weeks) |
| Change from baseline quality of life questionnaire | EORTC-QLQ-C30 | 3 weeks after last chemotherapy cycle (21 weeks) |
| Change from baseline depression screening questionnaire | DESC-I | 3 weeks after last chemotherapy cycle (21 weeks) |
| Change from baseline symptoms of polyneuropathy questionnaire | EORTC-QLQ-C30+CIPN20 | 3 weeks after last chemotherapy cycle (21 weeks) |
| Change from baseline symptoms of cognitive decline (questionnaire) | everyday memory test | 3 weeks after last chemotherapy cycle (21 weeks) |
| D009422 | Nervous System Diseases |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D060825 | Cognitive Dysfunction |