Chemotherapy-induced Cognitive Alterations in Recruits With Ovarian and Breast Cancer (CICARO)
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Change from baseline compound score of standardized neuropsychological test
Study Overview
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:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
Chemotherapy
patients with ovarian cancer and paclitaxel + carboplatin combination chemotherapy as well as patients with breast cancer and paclitaxel +/- carboplatin combination chemotherapy
Intervention: Chemotherapy (Drug)
Outcomes
Primary Outcomes
Change from baseline compound score of standardized neuropsychological test
Time Frame: 3 weeks after last chemotherapy cycle (21 weeks)
standardized neuropsychological test covering verbal memory, visual-spatial memory, short term/ working memory, executive functions
Secondary Outcomes
- Change from baseline depression screening questionnaire(3 weeks after last chemotherapy cycle (21 weeks))
- Change from baseline quality of life questionnaire(3 weeks after last chemotherapy cycle (21 weeks))
- Change from baseline symptoms of cognitive decline (questionnaire)(3 weeks after last chemotherapy cycle (21 weeks))
- Change from baseline cytokine profiling (serum sample)(3 weeks after last chemotherapy cycle (21 weeks))
- Change from baseline olfactory function(3 weeks after last chemotherapy cycle (21 weeks))
- Change from baseline total neuropathy score (TNSr)(3 weeks after last chemotherapy cycle (21 weeks))
- Change from baseline symptoms of polyneuropathy questionnaire(3 weeks after last chemotherapy cycle (21 weeks))
Investigators
Petra Huehnchen
resident and postdoctoral fellow
Charite University, Berlin, Germany