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Cognition in Breast Cancer Patients: The Impact of Cancer-related Stress (Cognicares)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by (Responsible Party):
Kerstin Hermelink, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT01264562
First received: December 20, 2010
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Cognition in Breast Cancer Patients: The Impact of Cancer-related Stress

Resource links provided by NLM:


Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • Course of cognitive function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Performance on a battery of cognitive tests


Secondary Outcome Measures:
  • Course of subjective cognitive function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Self-reported cognitive problems

  • Course of the HPA-axis function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Cortisol awakening response and diurnal profile

  • Course of the stress response [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Acute stress response, posttraumatic stress disorder, and posttraumatic stress symptoms; cancer-specific stress


Biospecimen Retention:   Samples Without DNA

Saliva


Enrollment: 254
Study Start Date: January 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01264562

Locations
Germany
Frauenklinik des 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
Klinikum Dritter Orden
Munich, Bavaria, Germany, 80638
Ludwig Maximilian University, Department of Gynecology and Obstetrics
Munich, Bavaria, Germany, 81377
Rotkreuzklinikum Muenchen
Munich, Bavaria, Germany, 80634
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Deutsche Krebshilfe e.V., Bonn (Germany)
Investigators
Principal Investigator: Kerstin Hermelink, PhD Ludwig Maximilian University, Department of Gynecology and Obstetrics
  More Information

Additional Information:
No publications provided

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
Study First Received: December 20, 2010
Last Updated: June 2, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Ludwig-Maximilians - University of Munich:
chemotherapy, adjuvant
adverse effects
breast neoplasms
cognition disorders
Stress Disorders, post-traumatic
cortisol

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 20, 2014