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

University of Franche-Comté

Status: Terminated

Conditions: Breast Cancer

Treatments: Other: Control Group; Other: Physical activity intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02433067

UFranche-Comte

Details and patient eligibility

About

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

Full 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.

Enrollment: 89 patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18 to 85 years
• First breast cancer HER2 + histologically confirmed,
• WHO grade Performance Index ≤1
• Normal renal function (creatinine clearance ≥ 60 ml min-1)
• Normal heart function with LVEF ≥ 50%
• Normal liver function (AST and ALT normal)
• Physical activity certificate issued by a cardiologist or an oncologist,
• Active contraception or postmenopausal

Exclusion criteria

• Patients aged under 18 and over 85
• Patients having no breast cancer HER2+
• Patients with metastases
• Heart failure (LVEF ≤50%) and respiratory (O2 saturation ≤ 92%),
• Autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis)
• Symptomatic osteoarthritis,
• Cardiovascular diseases (angina or uncontrolled high blood pressure) or heart-lung (chronic obstructive pulmonary disease)
• Patients suffering from malnutrition (Body Mass Index (BMI) <18 kg m-2) or weight loss of over 10% during the last 3 months,
• Patients with psychiatric or cognitive disorders deemed unsuitable for a sporting activity
• Pregnant or lactating Patients.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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89 participants in 2 patient groups

Physical activity intervention

Experimental group

Description:

- Arm A "standard oncologic care coupled with physical activity intervention (3 times / week) " during 3 months

Treatment:

Other: Physical activity intervention

Control group

Active Comparator group

Description:

- Arm B (control group) "standard oncologic care"

Treatment:

Other: Control Group