Clinical trial NCT02753036: Chemotherapy-induced Cognitive Alterations in Recruits With Ovarian and Breast Cancer
Official title: Chemotherapy-induced Cognitive Alterations in Recruits With Ovarian and Breast Cancer (CICARO)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cognition Disorders
Polyneuropathies
Keywords: cognition
chemotherapy
polyneuropathy
paclitaxel
cancer
chemobrain
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2016-04-27
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic, department of gynecology

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)

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline compound score of standardized neuropsychological test
timeFrame: 3 weeks after last chemotherapy cycle (21 weeks)
Secondary outcomes:
measure: Change from baseline olfactory function
timeFrame: 3 weeks after last chemotherapy cycle (21 weeks)
measure: Change from baseline total neuropathy score (TNSr)
timeFrame: 3 weeks after last chemotherapy cycle (21 weeks)
measure: Change from baseline cytokine profiling (serum sample)
timeFrame: 3 weeks after last chemotherapy cycle (21 weeks)
measure: Change from baseline quality of life questionnaire
timeFrame: 3 weeks after last chemotherapy cycle (21 weeks)
measure: Change from baseline depression screening questionnaire
timeFrame: 3 weeks after last chemotherapy cycle (21 weeks)
measure: Change from baseline symptoms of polyneuropathy questionnaire
timeFrame: 3 weeks after last chemotherapy cycle (21 weeks)
measure: Change from baseline symptoms of cognitive decline (questionnaire)
timeFrame: 3 weeks after last chemotherapy cycle (21 weeks)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Petra Huehnchen, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.