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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2020-10-31

Brief Summary

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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

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Detailed Description

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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

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Physical activity intervention

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

Group Type EXPERIMENTAL

Physical activity intervention

Intervention Type OTHER

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.

Control group

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

Group Type ACTIVE_COMPARATOR

Control Group

Intervention Type OTHER

standard oncologic care

Interventions

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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.

Intervention Type OTHER

Control Group

standard oncologic care

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No