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

NCT02753036 | Unknown DMC

• 1 other identifier: EA4/069/14
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognition Disorders; Polyneuropathies

Keywords

cognition; chemotherapy; polyneuropathy; paclitaxel; cancer; chemobrain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change from baseline olfactory function

  3 weeks after last chemotherapy cycle (21 weeks)

• Change from baseline total neuropathy score (TNSr)

  3 weeks after last chemotherapy cycle (21 weeks)

• Change from baseline cytokine profiling (serum sample)

  3 weeks after last chemotherapy cycle (21 weeks)

• Change from baseline quality of life questionnaire

  3 weeks after last chemotherapy cycle (21 weeks)

• Change from baseline depression screening questionnaire

  3 weeks after last chemotherapy cycle (21 weeks)

Study Arms (3)

Chemotherapy

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

Drug: Chemotherapy

Healthy control

patients with benign gynecological tumors after laparoscopic surgical resection

Tumor control

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

Interventions

Chemotherapy DRUG

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

Chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

primary care clinic, department of gynecology

You may qualify if:

• age
• written informed consent
• Karnofsky index \>70% / ECOG \<1
• at least 8 years of education

You may not qualify if:

• post surgical delirium
• major depression
• alcohol or drug abuse
• anemia \< 8 g/dl
• mild cognitive impairment or dementia
• previous neurotoxic chemotherapy treatment

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Related Publications (1)

• 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.

  PMID: 35133982 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

serum samples, PBMC

MeSH Terms

Conditions

Cognition Disorders; Polyneuropathies; Neoplasms; Chemotherapy-Related Cognitive Impairment

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Cognitive Dysfunction

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Petra Huehnchen, Dr.

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident and postdoctoral fellow

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: April 27, 2016
• Study Start: January 1, 2016
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: August 19, 2021

Record last verified: 2021-08

Locations

DE (1)