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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02433067
Recruitment Status : Terminated
First Posted : May 4, 2015
Last Update Posted : October 6, 2020
Sponsor:
Collaborators:
Ligue contre le cancer, France
Centre Hospitalier Universitaire de Besancon
Information provided by (Responsible Party):
Fabienne Mougin-Guillaume, University of Franche-Comté

Study Description
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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

Condition or disease Intervention/treatment Phase
Breast Cancer Other: Physical activity intervention Other: Control Group Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of Physical Activity Intervention on Myocardial Function in Patients With HER2 + Breast Cancer, During Treatment With Trastuzumab in Adjuvant
Study Start Date : April 2015
Actual Primary Completion Date : October 2020
Actual Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Physical activity intervention
- Arm A "standard oncologic care coupled with physical activity intervention (3 times / week) " during 3 months
 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.
Active Comparator: Control group
- Arm B (control group) "standard oncologic care"
 Other: Control Group
standard oncologic care


Outcome Measures
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Primary Outcome Measures :
  1. Left Ventricular Ejection Fraction (LVEF) [ Time Frame: The Left Ventricular Ejection Fraction (LVEF) will be evaluated baseline (T0), and 6 months (T6), to see if there is a significant change ]
    evaluated with echocardiography


Secondary Outcome Measures :
  1. Weight and volume of left and right ventricular [ Time Frame: baseline (T0), 3 months (T3) and 6 months (T6) ]
    evaluated with echocardiography

  2. Body composition [ Time Frame: baseline (T0), 3 months (T3) and 6 months (T6) ]
    evaluated byimpedance and with tape measure and pliers of Harpenden

  3. Metabolic responses [ Time Frame: baseline (T0), 3 months (T3) and 6 months (T6) ]
    evaluated with enzyme-linked immunosorbent assay (ELISA)

  4. Maximal voluntary quadriceps [ Time Frame: baseline (T0), 3 months (T3) and 6 months (T6) ]
    evaluated with chair quadriceps with strain gauge

  5. score of Quality of life [ Time Frame: Baseline (T0), 3 months (T3) and 6 months (T6) ]
    evaluated with questionnaire

  6. score of Pain [ Time Frame: Baseline (T0), 3 months (T3) and 6 months (T6) ]
    evaluated with questionnaire

  7. Fatigue [ Time Frame: baseline (T0), 3 months (T3) and 6 months (T6) ]
    evaluated with questionnaire

  8. Level of physical activity [ Time Frame: baseline (T0), 3 months (T3) and 6 months (T6) ]
    evaluated with questionnaire

  9. Pulmonary function (at rest and during exercise) [ Time Frame: baseline (T0), 3 months (T3) and 6 months (T6) ]
    evaluated with respiratory functional test and maximal exercise test

  10. hormonal responses [ Time Frame: baseline (T0), 3 months (T3) and 6 months (T6) ]
    evaluated with enzyme-linked immunosorbent assay (ELISA)

  11. inflammatory responses [ Time Frame: baseline (T0), 3 months (T3) and 6 months (T6) ]
    evaluated with enzyme-linked immunosorbent assay (ELISA)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02433067


Locations
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France
University Hospital
Besancon, Doubs, France, 25000
Sponsors and Collaborators
University of Franche-Comté
Ligue contre le cancer, France
Centre Hospitalier Universitaire de Besancon
Investigators
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Principal Investigator: Nathalie Meneveau University Hospital of Besançon
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Fabienne Mougin-Guillaume, Ph.D, University of Franche-Comté
ClinicalTrials.gov Identifier: NCT02433067    
Other Study ID Numbers: UFranche-Comte
First Posted: May 4, 2015    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases