NCT01264562

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
254

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2010

Completed
10 days until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

May 3, 2016

Status Verified

May 1, 2016

Enrollment Period

3.8 years

First QC Date

December 20, 2010

Last Update Submit

May 1, 2016

Conditions

Breast Cancer

Keywords

chemotherapy, adjuvantadverse effectsbreast neoplasmscognition disordersStress Disorders, post-traumaticcortisol

Outcome Measures

Primary Outcomes (1)

  • Course of cognitive function

    Performance on a battery of cognitive tests

    12 months

Secondary Outcomes (3)

  • Course of subjective cognitive function

    12 months

  • Course of the HPA-axis function

    12 months

  • Course of the stress response

    12 months

Study Arms (3)

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

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • primary breast cancer, stage 0-IIIc, therapy not yet started
  • informed consent
  • breast diagnostics with benign result (no treatment necessary)
  • informed consent

You may not qualify if:

  • not fluent in German
  • substance abuse
  • history of psychosis
  • history of neurologic disorder
  • previous systemic cancer treatment
  • Addison' disease
  • Cushing's syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Frauenklinik des Helios Amper Klinikums Dachau

Dachau, Bavaria, 85221, Germany

Location

Kreisklinik Ebersberg

Ebersberg, Bavaria, 85560, Germany

Location

Klinikum Landshut, Department of Obstetrics and Gynecology and Breast Cancer Services

Landshut, Bavaria, 84034, Germany

Location

Rotkreuzklinikum Muenchen

Munich, Bavaria, 80634, Germany

Location

Klinikum Dritter Orden

Munich, Bavaria, 80638, Germany

Location

Ludwig Maximilian University, Department of Gynecology and Obstetrics

Munich, Bavaria, 81377, Germany

Location

Related Publications (3)

  • 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.

    PMID: 27075856BACKGROUND

  • 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.

    PMID: 25882713RESULT

  • 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.

    PMID: 26898732RESULT

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva

MeSH Terms

Conditions

Breast NeoplasmsCognition DisordersStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeurocognitive DisordersMental DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Study Officials

  • Kerstin Hermelink, PhD

    Ludwig Maximilian University, Department of Gynecology and Obstetrics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Principal Investigator

Study Record Dates

First Submitted

December 20, 2010

First Posted

December 22, 2010

Study Start

January 1, 2011

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

May 3, 2016

Record last verified: 2016-05

Locations

DE(6)