Randomized Controlled Trial of Simultaneous Exercise During Neo-/Adjuvant Chemotherapy in Breast Cancer Patients and Its Effects on Neurocognition

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The ECCO-study evaluates the efficacy of simultaneous controlled exercise during neo/-adjuvant chemotherapy in breast cancer patients and its effects on neurocognition. In this study the investigators examine the benefits of the individualized high intensity training program on a cancer related cognitive impairment. Changes in patients' cognition are evaluated by neuropsychological testing. Possible structural changes are detected with MRI volumetry. Biomarkers connected to Cancer Related Cognitive Impairment (CRCI) and chemotherapy related inflammatory processes which impair cognition, respectively, will be assessed.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Histologically confirmed breast cancer and planned neo- and adjuvant chemotherapy

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Age 18 - 70 years

• Adequate hematologic functions 28d prior to randomization (Platelet count over 50 G/L, Hemoglobin over 8 g/dL)

• Able to perform exercise according to protocol

• Signed informed consent prior to randomization

• Fluid in German

Locations
Other Locations
Austria
Kepler University Hospital
RECRUITING
Linz
Contact Information
Primary
Milan R Vosko, MD, PhD
milan.vosko@kepleruniklinikum.at
+435768083
Backup
David Kiesl, MD
david.kiesl@kepleruniklinikum.at
+43768083
Time Frame
Start Date: 2019-12-01
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 126
Treatments
Active_comparator: Arm A: Exercise intervention arm
Placebo_comparator: Arm B: Control arm
Related Therapeutic Areas
Sponsors
Collaborators: University of Graz, German Sport University, Cologne, Charite University, Berlin, Germany, Charles University, Czech Republic
Leads: Johannes Kepler University of Linz

This content was sourced from clinicaltrials.gov