NCT02753036

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 72 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Cognition Disorders
• Polyneuropathies

Interventions

Type	Name	Description
DRUG	Chemotherapy	standard combination chemotherapy (paclitaxel +/- carboplatin) if necessary according to treatment guidelines

Timeline

• Start date: 2016-01-01
• Primary completion: 2022-12-31
• Completion: 2023-06-30
• First posted: 2016-04-27
• Last updated: 2021-08-19

Locations

1 site across 1 country: Germany