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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 : Recruiting
First Posted : April 27, 2016
Last Update Posted : July 21, 2017
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: Paclitaxel

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
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chemotherapy-induced Cognitive Alterations in Recruits With Ovarian and Breast Cancer (CICARO)
Study Start Date : January 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Group/Cohort Intervention/treatment
Chemotherapy Ovarian
patients with ovarian cancer and paclitaxel/ carboplatin combination chemotherapy
Drug: Paclitaxel
ovarian: carboplatin + paclitaxel breast: epirubicin + cyclophosphamide + paclitaxel

Control Ovarian
patients with benign gynecological tumors after surgical tumor resection
Chemotherapy Breast
patients with breast cancer and epirubicin/cyclophosphamide/paclitaxel combination chemotherapy
Drug: Paclitaxel
ovarian: carboplatin + paclitaxel breast: epirubicin + cyclophosphamide + paclitaxel

Control Breast
patients with breast cancer and radiation and/or antihormonal treatment



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 Without DNA
serum samples


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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 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


Contacts
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Contact: Petra Huehnchen, Dr. 0049-30-450-560137 petra.huehnchen@charite.de
Contact: Wolfgang Boehmerle, Dr., M.Sc. 0049-30-450-560137 wolfgang.boehmerle@charite.de

Locations
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Germany
Charité Universitätsmedizin Berlin Recruiting
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     History of Changes
Other Study ID Numbers: EA4/069/14
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
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
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action