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

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02753036
Collaborator
(none)
72
1
89.9
0.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Actual Enrollment :
72 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Chemotherapy-induced Cognitive Alterations in Recruits With Ovarian and Breast Cancer (CICARO)
Actual Study Start Date :
Jan 1, 2016
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Chemotherapy

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

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

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Change from baseline olfactory function [3 weeks after last chemotherapy cycle (21 weeks)]

    standardized test battery (Sniffin Sticks)

  2. 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

  3. Change from baseline cytokine profiling (serum sample) [3 weeks after last chemotherapy cycle (21 weeks)]

    ELISA of serum samples

  4. Change from baseline quality of life questionnaire [3 weeks after last chemotherapy cycle (21 weeks)]

    EORTC-QLQ-C30

  5. Change from baseline depression screening questionnaire [3 weeks after last chemotherapy cycle (21 weeks)]

    DESC-I

  6. Change from baseline symptoms of polyneuropathy questionnaire [3 weeks after last chemotherapy cycle (21 weeks)]

    EORTC-QLQ-C30+CIPN20

  7. Change from baseline symptoms of cognitive decline (questionnaire) [3 weeks after last chemotherapy cycle (21 weeks)]

    everyday memory test

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Charité Universitätsmedizin Berlin Berlin Germany 10117

Sponsors and Collaborators

  • Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Petra Huehnchen, Dr., Charite University, Berlin, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Petra Huehnchen, resident and postdoctoral fellow, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT02753036
Other Study ID Numbers:
  • EA4/069/14
First Posted:
Apr 27, 2016
Last Update Posted:
Aug 19, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Petra Huehnchen, resident and postdoctoral fellow, Charite University, Berlin, Germany
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 19, 2021