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

Charité University Medicine Berlin

Status: Unknown

Conditions: Polyneuropathies; Cognition Disorders

Treatments: Drug: Chemotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT02753036

EA4/069/14

Details and patient eligibility

About

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.

Full 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)

Enrollment: 72 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

72 participants in 3 patient groups

Chemotherapy

Description:

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

Treatment:

Drug: Chemotherapy

Healthy control

Description:

patients with benign gynecological tumors after laparoscopic surgical resection

Tumor control

Description:

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