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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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24 August 2021 |
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Main ID: |
NCT02753036 |
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Date of registration:
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20/04/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Chemotherapy-induced Cognitive Alterations in Recruits With Ovarian and Breast Cancer
CICARO |
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Scientific title:
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Chemotherapy-induced Cognitive Alterations in Recruits With Ovarian and Breast Cancer (CICARO) |
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Date of first enrolment:
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January 1, 2016 |
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Target sample size:
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72 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02753036 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Petra Huehnchen, Dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Charite University, Berlin, Germany |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Polyneuropathies
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Cognition Disorders
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Intervention(s)
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Drug: Chemotherapy
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Primary Outcome(s)
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Change from baseline compound score of standardized neuropsychological test
[Time Frame: 3 weeks after last chemotherapy cycle (21 weeks)]
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Secondary Outcome(s)
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Change from baseline symptoms of cognitive decline (questionnaire)
[Time Frame: 3 weeks after last chemotherapy cycle (21 weeks)]
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Change from baseline symptoms of polyneuropathy questionnaire
[Time Frame: 3 weeks after last chemotherapy cycle (21 weeks)]
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Change from baseline total neuropathy score (TNSr)
[Time Frame: 3 weeks after last chemotherapy cycle (21 weeks)]
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Change from baseline quality of life questionnaire
[Time Frame: 3 weeks after last chemotherapy cycle (21 weeks)]
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Change from baseline olfactory function
[Time Frame: 3 weeks after last chemotherapy cycle (21 weeks)]
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Change from baseline cytokine profiling (serum sample)
[Time Frame: 3 weeks after last chemotherapy cycle (21 weeks)]
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Change from baseline depression screening questionnaire
[Time Frame: 3 weeks after last chemotherapy cycle (21 weeks)]
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Secondary ID(s)
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EA4/069/14
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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