Breast CancerCognicaresNCT01264562
Cognition in Breast Cancer Patients: The Impact of Cancer-related Stress
An observational study of Breast Cancer, run by Ludwig-Maximilians - University of Munich at 6 sites in Germany.
Trial summary
The study will investigate the impact of cancer-related stress and its consequences (acute and posttraumatic stress symptoms, altered cortisol secretion) on cognitive function in breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 254 participants
- Where
- 6 sitesGermany
- Study dates
- Jan 2011to Oct 2014
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients of the Ludwig Maximilian University of Munich Breast Cancer Center; Klinikum Landshut Department of Obstetrics and Gynecology and Breast Cancer Services; Kreisklinik Ebersberg Department of Gynecology and Obstetrics; Klinikum Dritter Orden Department of Gynecology and Obstetrics; Rotkreuzklinikum Muenchen Department of Gynecology and Obstetrics, Helios Amper Hospital Dachau, Department of Gynecology and Obstetrics
Who may be able to join
- primary breast cancer, stage 0-IIIc, therapy not yet started
- informed consent
- breast diagnostics with benign result (no treatment necessary)
- informed consent
Who cannot join
- not fluent in German
- substance abuse
- history of psychosis
- history of neurologic disorder
- previous systemic cancer treatment
- Addison' disease
- Cushing's syndrome
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Frauenklinik des Helios Amper Klinikums Dachau
Dachau, Bavaria, 85221
Kreisklinik Ebersberg
Ebersberg, Bavaria, 85560
Klinikum Landshut, Department of Obstetrics and Gynecology and Breast Cancer Services
Landshut, Bavaria, 84034
Rotkreuzklinikum Muenchen
Munich, Bavaria, 80634
Klinikum Dritter Orden
Munich, Bavaria, 80638
Ludwig Maximilian University, Department of Gynecology and Obstetrics
Munich, Bavaria, 81377
About this study
The study will investigate the impact of cancer-related stress and its consequences (acute and posttraumatic stress symptoms, altered cortisol secretion) on cognitive function in breast cancer patients. The hypothesis that stress associated with the cancer diagnosis and the cancer treatment is a major cause of cognitive dysfunction in breast cancer patients shall be evaluated.
Read the detailed description
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
- Conditions
- Breast Cancer
- Keywords
- chemotherapy, adjuvant, adverse effects, breast neoplasms, cognition disorders, Stress Disorders, post-traumatic, cortisol
- Medical subject headings
- Breast Neoplasms, Cognition Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy group | Breast cancer patients treated with chemotherapy | |
| Non-chemotherapy group | Breast cancer patients not treated with chemotherapy | |
| Healthy controls | Women without a cancer diagnosis, matched for age and education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Course of cognitive function
Performance on a battery of cognitive tests
Measured: 12 months
Secondary outcomes (3)
Course of subjective cognitive function
Self-reported cognitive problems
Measured: 12 months
Course of the HPA-axis function
Cortisol awakening response and diurnal profile
Measured: 12 months
Course of the stress response
Acute stress response, posttraumatic stress disorder, and posttraumatic stress symptoms; cancer-specific stress
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Krebshilfe e.V., Bonn (Germany)
- Responsible party
- Principal investigator, Kerstin Hermelink, Ludwig-Maximilians - University of Munich
- Investigators
- Kerstin Hermelink, PhD, Principal investigator, Ludwig Maximilian University, Department of Gynecology and Obstetrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264562
- Sponsor's protocol ID
- DKH 109132
- Acronym
- Cognicares
- Status last verified
- May 2016
- First submitted
- 20 Dec 2010
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hermelink K, Buhner M, Harbeck N. Response. J Natl Cancer Inst. 2016 Apr 13;108(8):djw049. doi: 10.1093/jnci/djw049. Print 2016 Aug. No abstract available.
PubMed 27075856Hermelink K, Voigt V, Kaste J, Neufeld F, Wuerstlein R, Buhner M, Munzel K, Rjosk-Dendorfer D, Grandl S, Braun M, von Koch FE, Hartl K, Hasmuller S, Bauerfeind I, Debus G, Herschbach P, Harbeck N. Elucidating pretreatment cognitive impairment in breast cancer patients: the impact of cancer-related post-traumatic stress. J Natl Cancer Inst. 2015 Apr 16;107(7):djv099. doi: 10.1093/jnci/djv099. Print 2015 Jul.
PubMed 25882713Voigt V, Neufeld F, Kaste J, Buhner M, Sckopke P, Wuerstlein R, Hellerhoff K, Sztrokay-Gaul A, Braun M, von Koch FE, Silva-Zurcher E, Hasmuller S, Bauerfeind I, Debus G, Herschbach P, Mahner S, Harbeck N, Hermelink K. Clinically assessed posttraumatic stress in patients with breast cancer during the first year after diagnosis in the prospective, longitudinal, controlled COGNICARES study. Psychooncology. 2017 Jan;26(1):74-80. doi: 10.1002/pon.4102. Epub 2016 Feb 22.
PubMed 26898732
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognition in Breast Cancer Patients: The Impact of Cancer-related Stress
- ClinicalTrials.gov ID
- NCT01264562
- Acronym / sponsor ID
- Cognicares / DKH 109132
- Conditions
- Breast Cancer
- Keywords
- chemotherapy, adjuvant, adverse effects, breast neoplasms, cognition disorders, Stress Disorders, post-traumatic, cortisol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- Deutsche Krebshilfe e.V., Bonn (Germany)
- Study start
- Jan 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 22 Dec 2010 (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.
The study will investigate the impact of cancer-related stress and its consequences (acute and posttraumatic stress symptoms, altered cortisol secretion) on cognitive function in breast cancer patients. The hypothesis that stress associated with the cancer diagnosis and the cancer treatment is a major cause of cognitive dysfunction in breast cancer patients shall be evaluated.
Detailed description
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy group | – | –Breast cancer patients treated with chemotherapy |
| Non-chemotherapy group | – | –Breast cancer patients not treated with chemotherapy |
| Healthy controls | – | –Women without a cancer diagnosis, matched for age and education |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of the Ludwig Maximilian University of Munich Breast Cancer Center; Klinikum Landshut Department of Obstetrics and Gynecology and Breast Cancer Services; Kreisklinik Ebersberg Department of Gynecology and Obstetrics; Klinikum Dritter Orden Department of Gynecology and Obstetrics; Rotkreuzklinikum Muenchen Department of Gynecology and Obstetrics, Helios Amper Hospital Dachau, Department of Gynecology and Obstetrics
Key inclusion criteria (4 listed)
- primary breast cancer, stage 0-IIIc, therapy not yet started
- informed consent
- breast diagnostics with benign result (no treatment necessary)
- informed consent
Key exclusion criteria (7 listed)
- not fluent in German
- substance abuse
- history of psychosis
- history of neurologic disorder
- previous systemic cancer treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Course of cognitive function
Time frame: 12 months
Performance on a battery of cognitive tests
3 secondary outcomes
Course of subjective cognitive function
Time frame: 12 months
Course of the HPA-axis function
Time frame: 12 months
Course of the stress response
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2016.
- Background: PubMed 27075856Hermelink K, Buhner M, Harbeck N. Response. J Natl Cancer Inst. 2016 Apr 13;108(8):djw049. doi: 10.1093/jnci/djw049. Print 2016 Aug. No abstract available.
- Results publication: PubMed 25882713Hermelink K, Voigt V, Kaste J, Neufeld F, Wuerstlein R, Buhner M, Munzel K, Rjosk-Dendorfer D, Grandl S, Braun M, von Koch FE, Hartl K, Hasmuller S, Bauerfeind I, Debus G, Herschbach P, Harbeck N. Elucidating pretreatment cognitive impairment in breast cancer patients: the impact of cancer-related post-traumatic stress. J Natl Cancer Inst. 2015 Apr 16;107(7):djv099. doi: 10.1093/jnci/djv099. Print 2015 Jul.
- Results publication: PubMed 26898732Voigt V, Neufeld F, Kaste J, Buhner M, Sckopke P, Wuerstlein R, Hellerhoff K, Sztrokay-Gaul A, Braun M, von Koch FE, Silva-Zurcher E, Hasmuller S, Bauerfeind I, Debus G, Herschbach P, Mahner S, Harbeck N, Hermelink K. Clinically assessed posttraumatic stress in patients with breast cancer during the first year after diagnosis in the prospective, longitudinal, controlled COGNICARES study. Psychooncology. 2017 Jan;26(1):74-80. doi: 10.1002/pon.4102. Epub 2016 Feb 22.
- website of the Ludwig Maximilian University of Munich, Breast Cancer Center, Psycho-OncologyLink provided by the sponsor.
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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.
Kerstin Hermelink, PhD principal investigator
Ludwig Maximilian University, Department of Gynecology and Obstetrics
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Ludwig-Maximilians - University of Munich at 6 sites 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 7 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: finished, as of the sponsor's last update on 3 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Course of cognitive function (time frame: 12 months). 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 NCT01264562, which also lists 3 linked publications.
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 3 May 2016.