NCT02433067

Physical Activity Intervention on Myocardial Function in Patients With HER2 + Breast Cancer

Impact of Physical Activity Intervention on Myocardial Function in Patients With HER2 + Breast Cancer, During Treatment With Trastuzumab in Adjuvant

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: University of Franche-Comté · Academic / Other
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Purpose of the study is to examine the effects of 3 months of physical activity intervention on myocardial function (Left ventricular ejection fraction) in patients with HER2+ breast cancer

Detailed description

Primary objective: To evaluate in patients with HER2 + breast cancer, treated only by trastuzumab, the impact of three months individualized physical activity intervention (55 minutes, 3 times per week) on left ventricular ejection fraction (LVEF). Secondary objectives: To evaluate the impact of physical activity intervention on body composition, muscle function, metabolic, hormonal and inflammatory responses, pain, fatigue and quality of life. This study examines patients aged 18 to 85 years, diagnosed with early breast cancer with HER2 overexpression confirmed histologically and eligible to receive treatment with trastuzumab (adjuvant). This study includes 3 assessments phases: baseline (T0), 3 months (T3) and 6 months (T6) for both arms. The programme is organised as follows: Arm A "standard oncologic care coupled with physical activity intervention (3 times / week) " for 3 months ; Arm B (control group) "standard oncologic care". Between T3 and T6, volontary physical activity level will follow by actimetry.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	Physical activity intervention	Patients in arm A (interventional) will carry out a physical activity intervention during 3 months. Patients should perform an interval training program on cycle-ergometer during 3 sessions per week.
OTHER	Control Group	standard oncologic care

Timeline

• Start date: 2015-04-01
• Primary completion: 2020-10-01
• Completion: 2020-10-01
• First posted: 2015-05-04
• Last updated: 2020-10-06

Locations

1 site across 1 country: France