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

Breast Cancer Clinical Trial

— Cognicares  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01264562
• Other study ID #: DKH 109132
• Status: Completed
• Phase: N/A
• First received: December 20, 2010
• Last updated: May 1, 2016
• Start date: January 2011
• Est. completion date: October 2014

Study information

• Verified date: May 2016
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Germany	Frauenklinik des Helios Amper Klinikums Dachau	Dachau	Bavaria
Germany	Kreisklinik Ebersberg	Ebersberg	Bavaria
Germany	Klinikum Landshut, Department of Obstetrics and Gynecology and Breast Cancer Services	Landshut	Bavaria
Germany	Klinikum Dritter Orden	Munich	Bavaria
Germany	Ludwig Maximilian University, Department of Gynecology and Obstetrics	Munich	Bavaria
Germany	Rotkreuzklinikum Muenchen	Munich	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich	Deutsche Krebshilfe e.V., Bonn (Germany)

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Hermelink K, Bühner M, Harbeck N. Response. J Natl Cancer Inst. 2016 Apr 13;108(8). pii: djw049. doi: 10.1093/jnci/djw049. Print 2016 Aug. — View Citation

Hermelink K, Voigt V, Kaste J, Neufeld F, Wuerstlein R, Bühner M, Münzel K, Rjosk-Dendorfer D, Grandl S, Braun M, von Koch FE, Härtl K, Hasmüller S, Bauerfeind I, Debus G, Herschbach P, Harbeck N. Elucidating pretreatment cognitive impairment in breast ca — View Citation

Voigt V, Neufeld F, Kaste J, Bühner M, Sckopke P, Wuerstlein R, Hellerhoff K, Sztrókay-Gaul A, Braun M, von Koch FE, Silva-Zürcher E, Hasmüller S, Bauerfeind I, Debus G, Herschbach P, Mahner S, Harbeck N, Hermelink K. Clinically assessed posttraumatic str — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Course of cognitive function	Performance on a battery of cognitive tests	12 months	No
Secondary	Course of subjective cognitive function	Self-reported cognitive problems	12 months	No
Secondary	Course of the HPA-axis function	Cortisol awakening response and diurnal profile	12 months	No
Secondary	Course of the stress response	Acute stress response, posttraumatic stress disorder, and posttraumatic stress symptoms; cancer-specific stress	12 months	No

External Links

•   website of the Ludwig Maximilian University of Munich, Breast Cancer Center, Psycho-Oncology