Chemotherapy-induced Cognitive Alterations in Recruits With Ovarian and Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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Chemotherapy-induced Cognitive Alterations in Recruits With Ovarian and Breast Cancer (CICARO)

Conditions
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Cognition Disorders, Polyneuropathies

Intervention / Treatment
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* Drug: Chemotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chemotherapy<br>patients with ovarian cancer and paclitaxel + carboplatin combination chemotherapy as well as patients with breast cancer and paclitaxel +/- carboplatin combination chemotherapy | Drug: Chemotherapy<br>* standard combination chemotherapy (paclitaxel +/- carboplatin) if necessary according to treatment guidelines<br>|
| Healthy control<br>patients with benign gynecological tumors after laparoscopic surgical resection | |
| Tumor control<br>patients with breast cancer with anti-hormonal and/or localized radiation treatment but no chemotherapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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polyneuropathy, cognition, chemotherapy, paclitaxel, cancer, chemobrain