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The purpose of this study is to assess the feasibility of a home-based adapted physical activity during neoadjuvant chemotherapy for HER2+ breast cancer.
After the assessment of their physical fitness, a home-based adapted physical activity program composed by aerobic and muscle strengthening exercises will be delivered to each patient. The aim of the intervention is to reach international recommendation in a progressive way during neoadjuvant chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional | Experimental | Home-Based Adapted Physical Activity intervention during neoadjuvant chemotherapy : 150 minutes per week of aerobic and muscle strengthening exercises during 18 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-based Adapted Physical Activity | Other | Home-based adapted physical activity to attend progressively 150 minutes of physical activity per week at the end of neoadjuvant chemotherapy. 5 times 30 minutes of walking + 3 times 30 minutes of muscle strengthening exercises per week during 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients reaching international physical activity recommendations for post-neoadjuvant chemotherapy assessment | Time spent to physical activity and sedentariness will be evaluated by Recent Physical Activity Questionnaire (RPAQ) | Change from baseline (T0: before neoadjuvant chemotherapy) at the 5 months (T1: end of neoadjuvant chemotherapy) |
| Measure | Description | Time Frame |
|---|---|---|
| Longitudinal evolution of RPAQ score | Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy | |
| Quality of life : Quality of Life Questionnaire-C30 | Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xavier DURANDO, MD | Centre Jean Perrin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Jean Perrin | Clermont-Ferrand | 63011 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34966667 | Derived | Ginzac A, Bernadach M, Molnar I, Duclos M, Thivat E, Durando X. Adapted Physical Activity for Breast Cancer Patients Treated with Neoadjuvant Chemotherapy and Trastuzumab Against HER2 (APACAN2): A Protocol for a Feasibility Study. Front Oncol. 2021 Dec 13;11:744609. doi: 10.3389/fonc.2021.744609. eCollection 2021. |
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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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|
| Asthenia : Multidimensional Fatigue Inventory-20 | Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy |
| Anthropometrics measurements | BMI | Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy |
| Anthropometrics measurements | Hip circumference (cm) | Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy |
| Physical capacity : six-minutes walking distance test | Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy |
| Physical capacity : Voluntary muscular strength | Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy |
| Physical capacity : VO2max | This measure is optional | Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy |
| Lipid profile : total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides | Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy |
| Ventricular ejection fraction assessed by echocardiography or cardiac scintigraphy | Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy |
| Changes of cancer treatment | frequency of dose reduction (%), of postponement (%) or of treatment discontinuation (%) | At each cycle of neoadjuvant chemotherapy : every three weeks during 5 months |
| Assessment of physical activity level using a validated smartphone application (eMouveRecherche) | Including sedentariness time | Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy |
| D017437 |
| Skin and Connective Tissue Diseases |