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

• Conditions: Cognition Disorders; Polyneuropathies
• Interventions: Drug: Chemotherapy

• Registration Number: NCT02753036
• Lead Sponsor: Charite University, Berlin, Germany

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)

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2016-04-20
• Study First Submitted QC: 2016-04-25
• Study First Posted: 2016-04-27
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-13
• Last Update Posted: 2021-08-19
• Primary Completion: 2022-12-31
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 72

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chemotherapy	Chemotherapy	patients with ovarian cancer and paclitaxel + carboplatin combination chemotherapy as well as patients with breast cancer and paclitaxel +/- carboplatin combination chemotherapy

Primary Outcome Measures

Name	Time	Method
Change from baseline compound score of standardized neuropsychological test	3 weeks after last chemotherapy cycle (21 weeks)	standardized neuropsychological test covering verbal memory, visual-spatial memory, short term/ working memory, executive functions

Secondary Outcome Measures

Name	Time	Method
Change from baseline depression screening questionnaire	3 weeks after last chemotherapy cycle (21 weeks)	DESC-I
Change from baseline quality of life questionnaire	3 weeks after last chemotherapy cycle (21 weeks)	EORTC-QLQ-C30
Change from baseline symptoms of cognitive decline (questionnaire)	3 weeks after last chemotherapy cycle (21 weeks)	everyday memory test
Change from baseline cytokine profiling (serum sample)	3 weeks after last chemotherapy cycle (21 weeks)	ELISA of serum samples
Change from baseline olfactory function	3 weeks after last chemotherapy cycle (21 weeks)	standardized test battery (Sniffin Sticks)
Change from baseline total neuropathy score (TNSr)	3 weeks after last chemotherapy cycle (21 weeks)	reduced version includes clinical examination and neurography of sural and peroneal nerve
Change from baseline symptoms of polyneuropathy questionnaire	3 weeks after last chemotherapy cycle (21 weeks)	EORTC-QLQ-C30+CIPN20

Trial Locations

Locations (1)

Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany