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

Cognition Disorders Clinical Trial

— CICARO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02753036
• Other study ID #: EA4/069/14
• Status: Active, not recruiting
• Start date: January 1, 2016
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2021
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognition Disorders
• Polyneuropathies

Intervention

Drug:
• Chemotherapy
standard combination chemotherapy (paclitaxel +/- carboplatin) if necessary according to treatment guidelines

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline olfactory function	standardized test battery (Sniffin Sticks)	3 weeks after last chemotherapy cycle (21 weeks)
Secondary	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)
Secondary	Change from baseline cytokine profiling (serum sample)	ELISA of serum samples	3 weeks after last chemotherapy cycle (21 weeks)
Secondary	Change from baseline quality of life questionnaire	EORTC-QLQ-C30	3 weeks after last chemotherapy cycle (21 weeks)
Secondary	Change from baseline depression screening questionnaire	DESC-I	3 weeks after last chemotherapy cycle (21 weeks)
Secondary	Change from baseline symptoms of polyneuropathy questionnaire	EORTC-QLQ-C30+CIPN20	3 weeks after last chemotherapy cycle (21 weeks)
Secondary	Change from baseline symptoms of cognitive decline (questionnaire)	everyday memory test	3 weeks after last chemotherapy cycle (21 weeks)