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

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ClinicalTrials.gov Identifier: NCT02753036
Recruitment Status : Active, not recruiting
First Posted : April 27, 2016
Last Update Posted : August 19, 2021
Sponsor:
Information provided by (Responsible Party):
Petra Huehnchen, Charite University, Berlin, Germany

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
Cognition Disorders Polyneuropathies Drug: Chemotherapy

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)

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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 : January 1, 2016
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Group/Cohort 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



Primary Outcome Measures :
  1. Change from baseline compound score of standardized neuropsychological test [ Time Frame: 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 [ Time Frame: 3 weeks after last chemotherapy cycle (21 weeks) ]
    standardized test battery (Sniffin Sticks)

  2. Change from baseline total neuropathy score (TNSr) [ Time Frame: 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) [ Time Frame: 3 weeks after last chemotherapy cycle (21 weeks) ]
    ELISA of serum samples

  4. Change from baseline quality of life questionnaire [ Time Frame: 3 weeks after last chemotherapy cycle (21 weeks) ]
    EORTC-QLQ-C30

  5. Change from baseline depression screening questionnaire [ Time Frame: 3 weeks after last chemotherapy cycle (21 weeks) ]
    DESC-I

  6. Change from baseline symptoms of polyneuropathy questionnaire [ Time Frame: 3 weeks after last chemotherapy cycle (21 weeks) ]
    EORTC-QLQ-C30+CIPN20

  7. Change from baseline symptoms of cognitive decline (questionnaire) [ Time Frame: 3 weeks after last chemotherapy cycle (21 weeks) ]
    everyday memory test


Biospecimen Retention:   Samples With DNA
serum samples, PBMC


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
primary care clinic, department of gynecology
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02753036


Locations
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Germany
Charité Universitätsmedizin Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Petra Huehnchen, Dr. Charite University, Berlin, Germany
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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: April 27, 2016    Key Record Dates
Last Update Posted: August 19, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Petra Huehnchen, Charite University, Berlin, Germany:
cognition
chemotherapy
polyneuropathy
paclitaxel
cancer
chemobrain
Additional relevant MeSH terms:
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Polyneuropathies
Cognition Disorders
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders