Clinical trial NCT01264562: Cognition in Breast Cancer Patients: The Impact of Cancer-related Stress
Official title: Cognition in Breast Cancer Patients: The Impact of Cancer-related Stress
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: chemotherapy, adjuvant
adverse effects
breast neoplasms
cognition disorders
Stress Disorders, post-traumatic
cortisol
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: Deutsche Krebshilfe e.V., Bonn (Germany)
First posted: 2010-12-22
Enrollment: 254
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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, Helios Amper Hospital Dachau, Department of Gynecology and Obstetrics

Brief 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.

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 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

Primary outcomes:
measure: Course of cognitive function
timeFrame: 12 months
Secondary outcomes:
measure: Course of subjective cognitive function
timeFrame: 12 months
measure: Course of the HPA-axis function
timeFrame: 12 months
measure: Course of the stress response
timeFrame: 12 months
Other outcomes:
Locations:
city: Dachau
country: Germany
facility: Frauenklinik des Helios Amper Klinikums Dachau
state: Bavaria
city: Ebersberg
country: Germany
facility: Kreisklinik Ebersberg
state: Bavaria
city: Landshut
country: Germany
facility: Klinikum Landshut, Department of Obstetrics and Gynecology and Breast Cancer Services
state: Bavaria
city: Munich
country: Germany
facility: Rotkreuzklinikum Muenchen
state: Bavaria
city: Munich
country: Germany
facility: Klinikum Dritter Orden
state: Bavaria
city: Munich
country: Germany
facility: Ludwig Maximilian University, Department of Gynecology and Obstetrics
state: Bavaria
Study officials:
affiliation: Ludwig Maximilian University, Department of Gynecology and Obstetrics
name: Kerstin Hermelink, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Hermelink 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.
citation: Voigt 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.