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

NCT ID: NCT02753036

Last Updated: 2021-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 72 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2023-06-30

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)

Conditions

Cognition Disorders; Polyneuropathies

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Chemotherapy

patients with ovarian cancer and paclitaxel + carboplatin combination chemotherapy as well as patients with breast cancer and paclitaxel +/- carboplatin combination chemotherapy

Chemotherapy

Intervention Type: DRUG

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

Healthy control

patients with benign gynecological tumors after laparoscopic surgical resection

No interventions assigned to this group

Tumor control

patients with breast cancer with anti-hormonal and/or localized radiation treatment but no chemotherapy

No interventions assigned to this group

Interventions

Chemotherapy

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Petra Huehnchen

resident and postdoctoral fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Petra Huehnchen, Dr.

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

Charité Universitätsmedizin Berlin

Berlin, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 35133982 (View on PubMed)

Other Identifiers

EA4/069/14

Identifier Type: -

Identifier Source: org_study_id