Clinical trial · Observational
Chemotherapy-induced Cognitive Alterations in Recruits With Ovarian and Breast Cancer
Chemotherapy-induced Cognitive Alterations in Recruits With Ovarian and Breast Cancer (CICARO)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cognition Disorders | — | UNRESOLVED | — |
| Polyneuropathies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
Design
Arms and outcomes
Arms (3)
- label
- Chemotherapy
- description
- patients with ovarian cancer and paclitaxel + carboplatin combination chemotherapy as well as patients with breast cancer and paclitaxel +/- carboplatin combination chemotherapy
- interventionNames
- Drug: Chemotherapy
- label
- Healthy control
- description
- patients with benign gynecological tumors after laparoscopic surgical resection
- label
- Tumor control
- description
- patients with breast cancer with anti-hormonal and/or localized radiation treatment but no chemotherapy
Primary outcomes (1)
- measure
- Change from baseline compound score of standardized neuropsychological test
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHuehnchen 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. PMID 35133982