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

Breast Cancer Clinical Trial

— CARDAPAC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02433067
• Other study ID #: UFranche-Comte
• Status: Terminated
• Phase: N/A
• Start date: April 2015
• Est. completion date: October 2020

Study information

• Verified date: October 2020
• Source: University of Franche-Comté
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 89
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.
• Control Group
standard oncologic care

Locations

Country	Name	City	State
France	University Hospital	Besancon	Doubs

Sponsors (3)

Lead Sponsor	Collaborator
University of Franche-Comté	Centre Hospitalier Universitaire de Besancon, Ligue contre le cancer, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left Ventricular Ejection Fraction (LVEF)	evaluated with echocardiography	The Left Ventricular Ejection Fraction (LVEF) will be evaluated baseline (T0), and 6 months (T6), to see if there is a significant change
Secondary	Weight and volume of left and right ventricular	evaluated with echocardiography	baseline (T0), 3 months (T3) and 6 months (T6)
Secondary	Body composition	evaluated byimpedance and with tape measure and pliers of Harpenden	baseline (T0), 3 months (T3) and 6 months (T6)
Secondary	Metabolic responses	evaluated with enzyme-linked immunosorbent assay (ELISA)	baseline (T0), 3 months (T3) and 6 months (T6)
Secondary	Maximal voluntary quadriceps	evaluated with chair quadriceps with strain gauge	baseline (T0), 3 months (T3) and 6 months (T6)
Secondary	score of Quality of life	evaluated with questionnaire	Baseline (T0), 3 months (T3) and 6 months (T6)
Secondary	score of Pain	evaluated with questionnaire	Baseline (T0), 3 months (T3) and 6 months (T6)
Secondary	Fatigue	evaluated with questionnaire	baseline (T0), 3 months (T3) and 6 months (T6)
Secondary	Level of physical activity	evaluated with questionnaire	baseline (T0), 3 months (T3) and 6 months (T6)
Secondary	Pulmonary function (at rest and during exercise)	evaluated with respiratory functional test and maximal exercise test	baseline (T0), 3 months (T3) and 6 months (T6)
Secondary	hormonal responses	evaluated with enzyme-linked immunosorbent assay (ELISA)	baseline (T0), 3 months (T3) and 6 months (T6)
Secondary	inflammatory responses	evaluated with enzyme-linked immunosorbent assay (ELISA)	baseline (T0), 3 months (T3) and 6 months (T6)