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Spots Global Cancer Trial Database for Physical Activity Intervention on Myocardial Function in Patients With HER2 + Breast Cancer

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Trial Identification

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

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

Study ID: NCT02433067

Conditions

Breast Cancer

Study Description

Brief 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

University Hospital, Besancon, Doubs, France

Contact Details

Name: Nathalie Meneveau

Affiliation: University Hospital of Besançon

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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