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

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

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

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Physical activity intervention; Other: Control Group

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 Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Doubs
    • Besancon, Doubs, France, 25000
      • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight and volume of left and right ventricular	evaluated with echocardiography	baseline (T0), 3 months (T3) and 6 months (T6)
Body composition	evaluated byimpedance and with tape measure and pliers of Harpenden	baseline (T0), 3 months (T3) and 6 months (T6)
Metabolic responses	evaluated with enzyme-linked immunosorbent assay (ELISA)	baseline (T0), 3 months (T3) and 6 months (T6)
Maximal voluntary quadriceps	evaluated with chair quadriceps with strain gauge	baseline (T0), 3 months (T3) and 6 months (T6)
score of Quality of life	evaluated with questionnaire	Baseline (T0), 3 months (T3) and 6 months (T6)
score of Pain	evaluated with questionnaire	Baseline (T0), 3 months (T3) and 6 months (T6)
Fatigue	evaluated with questionnaire	baseline (T0), 3 months (T3) and 6 months (T6)
Level of physical activity	evaluated with questionnaire	baseline (T0), 3 months (T3) and 6 months (T6)
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)
hormonal responses	evaluated with enzyme-linked immunosorbent assay (ELISA)	baseline (T0), 3 months (T3) and 6 months (T6)
inflammatory responses	evaluated with enzyme-linked immunosorbent assay (ELISA)	baseline (T0), 3 months (T3) and 6 months (T6)

Collaborators and Investigators

• Sponsor: University of Franche-Comté
• Collaborators: Centre Hospitalier Universitaire de Besancon; Ligue contre le cancer, France
• Investigators: Principal Investigator: Nathalie Meneveau, University Hospital of Besancon

Publications and helpful links

General Publications

• Jacquinot Q, Meneveau N, Falcoz A, Bouhaddi M, Roux P, Degano B, Chatot M, Curtit E, Mansi L, Paillard MJ, Bazan F, Chaigneau L, Dobi E, Meynard G, Vernerey D, Pivot X, Mougin F. Cardiotoxicity is mitigated after a supervised exercise program in HER2-positive breast cancer undergoing adjuvant trastuzumab. Front Cardiovasc Med. 2022 Sep 23;9:1000846. doi: 10.3389/fcvm.2022.1000846. eCollection 2022.
• Jacquinot Q, Meneveau N, Chatot M, Bonnetain F, Degano B, Bouhaddi M, Dumoulin G, Vernerey D, Pivot X, Mougin F. A phase 2 randomized trial to evaluate the impact of a supervised exercise program on cardiotoxicity at 3 months in patients with HER2 overexpressing breast cancer undergoing adjuvant treatment by trastuzumab: design of the CARDAPAC study. BMC Cancer. 2017 Jun 19;17(1):425. doi: 10.1186/s12885-017-3420-4.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: April 14, 2015
• First Submitted That Met QC Criteria: April 28, 2015
• First Posted (Estimate): May 4, 2015

Study Record Updates

• Last Update Posted (Actual): October 6, 2020
• Last Update Submitted That Met QC Criteria: October 5, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: UFranche-Comte