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

NCT02753036 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 72

Last updated 2021-08-19

No results posted yet for this study

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.

Conditions

  • Cognition Disorders
  • Polyneuropathies

Interventions

DRUG

Chemotherapy

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

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Petra Huehnchen, Dr. · Charite University, Berlin, Germany

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-01
Primary Completion
2022-12-31
Completion
2023-06-30

Countries

  • Germany

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02753036 on ClinicalTrials.gov