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| Name | Class |
|---|---|
| Ligue contre le cancer, France | OTHER |
| Centre Hospitalier Universitaire de Besancon | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical activity intervention | Experimental | - Arm A "standard oncologic care coupled with physical activity intervention (3 times / week) " during 3 months |
|
| Control group | Active Comparator | - Arm B (control group) "standard oncologic care" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical activity intervention | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathalie Meneveau | University Hospital of Besançon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Besançon | Doubs | 25000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41636910 | Derived | Jacquinot Q, Ennequin G, Falcoz A, Sawyer D, Meneveau N, Mougin F. Exercise training decreases Neuregulin-1 concentrations in HER2-positive breast cancer patients undergoing adjuvant trastuzumab: the CARDAPAC study. Breast Cancer Res Treat. 2026 Feb 4;215(3):69. doi: 10.1007/s10549-026-07903-x. | |
| 36211552 | Derived |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control Group | Other | standard oncologic care |
|
| 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) |
| 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. |
| 28629338 | Derived | 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. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D008722 | Methods |