Cognition DisordersCICARONCT02753036
Chemotherapy-induced Cognitive Alterations in Recruits With Ovarian and Breast Cancer
An observational study of Cognition Disorders and Polyneuropathies, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cognition Disorders, Polyneuropathies
- What is being tested?
- Chemotherapy
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2016to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic, department of gynecology
Who may be able to join
- age
- written informed consent
- Karnofsky index >70% / ECOG <1
- at least 8 years of education
Who cannot join
- post surgical delirium
- major depression
- alcohol or drug abuse
- anemia < 8 g/dl
- mild cognitive impairment or dementia
- previous neurotoxic chemotherapy treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chemotherapy-induced Cognitive Alterations in Recruits With Ovarian and Breast Cancer (CICARO)
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.
Read the 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)
- Conditions
- Cognition Disorders, Polyneuropathies
- Being tested
- Chemotherapy
- Keywords
- cognition, chemotherapy, polyneuropathy, paclitaxel, cancer, chemobrain
- Medical subject headings
- Cognition Disorders, Polyneuropathies, Neoplasms, Chemotherapy-Related Cognitive Impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
standard combination chemotherapy (paclitaxel +/- carboplatin) if necessary according to treatment guidelines
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy | patients with ovarian cancer and paclitaxel + carboplatin combination chemotherapy as well as patients with breast cancer and paclitaxel +/- carboplatin combination chemotherapy Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline compound score of standardized neuropsychological test
standardized neuropsychological test covering verbal memory, visual-spatial memory, short term/ working memory, executive functions
Measured: 3 weeks after last chemotherapy cycle (21 weeks)
Secondary outcomes (7)
Change from baseline olfactory function
standardized test battery (Sniffin Sticks)
Measured: 3 weeks after last chemotherapy cycle (21 weeks)
Change from baseline total neuropathy score (TNSr)
reduced version includes clinical examination and neurography of sural and peroneal nerve
Measured: 3 weeks after last chemotherapy cycle (21 weeks)
Change from baseline cytokine profiling (serum sample)
ELISA of serum samples
Measured: 3 weeks after last chemotherapy cycle (21 weeks)
Change from baseline quality of life questionnaire
EORTC-QLQ-C30
Measured: 3 weeks after last chemotherapy cycle (21 weeks)
Change from baseline depression screening questionnaire
DESC-I
Measured: 3 weeks after last chemotherapy cycle (21 weeks)
Change from baseline symptoms of polyneuropathy questionnaire
EORTC-QLQ-C30+CIPN20
Measured: 3 weeks after last chemotherapy cycle (21 weeks)
Change from baseline symptoms of cognitive decline (questionnaire)
everyday memory test
Measured: 3 weeks after last chemotherapy cycle (21 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study start1 Jan 2016
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognition DisordersStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petra Huehnchen, Charite University, Berlin, Germany
- Investigators
- Petra Huehnchen, Dr., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753036
- Sponsor's protocol ID
- EA4/069/14
- Acronym
- CICARO
- Status last verified
- Aug 2021
- First submitted
- 20 Apr 2016
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 35133982
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy-induced Cognitive Alterations in Recruits With Ovarian and Breast Cancer (CICARO)
- ClinicalTrials.gov ID
- NCT02753036
- Acronym / sponsor ID
- CICARO / EA4/069/14
- Conditions
- Cognition Disorders, Polyneuropathies
- Keywords
- cognition, chemotherapy, polyneuropathy, paclitaxel, cancer, chemobrain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 27 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | – | Drug: Chemotherapypatients with ovarian cancer and paclitaxel + carboplatin combination chemotherapy as well as patients with breast cancer and paclitaxel +/- carboplatin combination 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic, department of gynecology
Key inclusion criteria (4 listed)
- age
- written informed consent
- Karnofsky index >70% / ECOG <1
- at least 8 years of education
Key exclusion criteria (6 listed)
- post surgical delirium
- major depression
- alcohol or drug abuse
- anemia < 8 g/dl
- mild cognitive impairment or dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chemotherapystandard combination chemotherapy (paclitaxel +/- carboplatin) if necessary according to treatment guidelines | Drug | Chemotherapy |
Primary outcome
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
7 secondary outcomes
Change from baseline olfactory function
Time frame: 3 weeks after last chemotherapy cycle (21 weeks)
Change from baseline total neuropathy score (TNSr)
Time frame: 3 weeks after last chemotherapy cycle (21 weeks)
Change from baseline cytokine profiling (serum sample)
Time frame: 3 weeks after last chemotherapy cycle (21 weeks)
Change from baseline quality of life questionnaire
Time frame: 3 weeks after last chemotherapy cycle (21 weeks)
Change from baseline depression screening questionnaire
Time frame: 3 weeks after last chemotherapy cycle (21 weeks)
Change from baseline symptoms of polyneuropathy questionnaire
Time frame: 3 weeks after last chemotherapy cycle (21 weeks)
Change from baseline symptoms of cognitive decline (questionnaire)
Time frame: 3 weeks after last chemotherapy cycle (21 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- Derived from this study: PubMed 35133982Huehnchen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petra Huehnchen, Dr. principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognition Disorders and Polyneuropathies, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline compound score of standardized neuropsychological test (time frame: 3 weeks after last chemotherapy cycle (21 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02753036, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.