Cognition in Breast Cancer Patients: The Impact of Cancer-related Stress (Cognicares)
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ClinicalTrials.gov Identifier: NCT01264562 |
Recruitment Status
:
Completed
First Posted
: December 22, 2010
Last Update Posted
: May 3, 2016
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Condition or disease |
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Breast Cancer |
Primary hypothesis:
*The adverse effects of cancer and cancer therapy on cognitive function in breast cancer patients are entirely or partly mediated by stress and the ensuing dysfunction of the HPA-axis.
Secondary objectives:
- Determining the effect of cancer diagnosis, chemotherapy, disease-related stress, acute stress response, posttraumatic stress disorder, posttraumatic stress symptoms, anxiety, and depression on the HPA-axis in breast cancer patients
- Determining the effect of cognitive dysfunction assessed with neuropsychological tests, cancer diagnosis, chemotherapy, disease-related stress, acute stress response, posttraumatic stress disorder, posttraumatic stress symptoms, anxiety, and depression on subjective cognitive function in breast cancer patients
- Prevalence of acute stress response, posttraumatic stress disorder and posttraumatic stress symptoms, and extent of cancer-specific stress in breast cancer patients treated with or without chemotherapy
Study Type : | Observational |
Actual Enrollment : | 254 participants |
Observational Model: | Case Control |
Time Perspective: | Prospective |
Official Title: | Cognition in Breast Cancer Patients: The Impact of Cancer-related Stress |
Study Start Date : | January 2011 |
Actual Primary Completion Date : | October 2014 |
Actual Study Completion Date : | October 2014 |

Group/Cohort |
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Chemotherapy group
Breast cancer patients treated with chemotherapy
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Non-chemotherapy group
Breast cancer patients not treated with chemotherapy
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Healthy controls
Women without a cancer diagnosis, matched for age and education
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- Course of cognitive function [ Time Frame: 12 months ]Performance on a battery of cognitive tests
- Course of subjective cognitive function [ Time Frame: 12 months ]Self-reported cognitive problems
- Course of the HPA-axis function [ Time Frame: 12 months ]Cortisol awakening response and diurnal profile
- Course of the stress response [ Time Frame: 12 months ]Acute stress response, posttraumatic stress disorder, and posttraumatic stress symptoms; cancer-specific stress
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria, both patient groups:
- primary breast cancer, stage 0-IIIc, therapy not yet started
- informed consent
Inclusion Criteria, healthy control group:
- breast diagnostics with benign result (no treatment necessary)
- informed consent
Exclusion Criteria:
- not fluent in German
- substance abuse
- history of psychosis
- history of neurologic disorder
- previous systemic cancer treatment
- Addison' disease
- Cushing's syndrome

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): NCT01264562
Germany | |
Frauenklinik des Helios Amper Klinikums Dachau | |
Dachau, Bavaria, Germany, 85221 | |
Kreisklinik Ebersberg | |
Ebersberg, Bavaria, Germany, 85560 | |
Klinikum Landshut, Department of Obstetrics and Gynecology and Breast Cancer Services | |
Landshut, Bavaria, Germany, 84034 | |
Rotkreuzklinikum Muenchen | |
Munich, Bavaria, Germany, 80634 | |
Klinikum Dritter Orden | |
Munich, Bavaria, Germany, 80638 | |
Ludwig Maximilian University, Department of Gynecology and Obstetrics | |
Munich, Bavaria, Germany, 81377 |
Principal Investigator: | Kerstin Hermelink, PhD | Ludwig Maximilian University, Department of Gynecology and Obstetrics |
Additional Information:
Publications of Results:
Other Publications:
Responsible Party: | Kerstin Hermelink, Study Principal Investigator, Ludwig-Maximilians - University of Munich |
ClinicalTrials.gov Identifier: | NCT01264562 History of Changes |
Other Study ID Numbers: |
DKH 109132 |
First Posted: | December 22, 2010 Key Record Dates |
Last Update Posted: | May 3, 2016 |
Last Verified: | May 2016 |
Keywords provided by Kerstin Hermelink, Ludwig-Maximilians - University of Munich:
chemotherapy, adjuvant adverse effects breast neoplasms |
cognition disorders Stress Disorders, post-traumatic cortisol |
Additional relevant MeSH terms:
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |