Clinical trial NCT02433067: Physical Activity Intervention on Myocardial Function in Patients With HER2 + Breast Cancer
Official title: Impact of Physical Activity Intervention on Myocardial Function in Patients With HER2 + Breast Cancer, During Treatment With Trastuzumab in Adjuvant
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Franche-Comté
Sponsor class: OTHER
Collaborators: name: Ligue contre le cancer, France
name: Centre Hospitalier Universitaire de Besancon
First posted: 2015-05-04
Enrollment: 89
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility 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.

Primary outcomes:
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: The Left Ventricular Ejection Fraction (LVEF) will be evaluated baseline (T0), and 6 months (T6), to see if there is a significant change
Secondary outcomes:
measure: Weight and volume of left and right ventricular
timeFrame: baseline (T0), 3 months (T3) and 6 months (T6)
measure: Body composition
timeFrame: baseline (T0), 3 months (T3) and 6 months (T6)
measure: Metabolic responses
timeFrame: baseline (T0), 3 months (T3) and 6 months (T6)
measure: Maximal voluntary quadriceps
timeFrame: baseline (T0), 3 months (T3) and 6 months (T6)
measure: score of Quality of life
timeFrame: Baseline (T0), 3 months (T3) and 6 months (T6)
measure: score of Pain
timeFrame: Baseline (T0), 3 months (T3) and 6 months (T6)
measure: Fatigue
timeFrame: baseline (T0), 3 months (T3) and 6 months (T6)
measure: Level of physical activity
timeFrame: baseline (T0), 3 months (T3) and 6 months (T6)
measure: Pulmonary function (at rest and during exercise)
timeFrame: baseline (T0), 3 months (T3) and 6 months (T6)
measure: hormonal responses
timeFrame: baseline (T0), 3 months (T3) and 6 months (T6)
measure: inflammatory responses
timeFrame: baseline (T0), 3 months (T3) and 6 months (T6)
Other outcomes:
Locations:
city: Besancon
country: France
facility: University Hospital
state: Doubs
Study officials:
affiliation: University Hospital of Besançon
name: Nathalie Meneveau
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.