Adapted Physical Activity for Breast Cancer HER2 Positive Patient

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the feasibility of a home-based adapted physical activity during neoadjuvant chemotherapy for HER2+ breast cancer.

Detailed Description
-----------------
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.

Official Title
-----------------
Feasibility Study of an Adapted Physical Activity (APA) for Breast Cancer Patients Treated by Neoadjuvant Chemotherapy and Targeted Therapy Against HER2

Conditions
-----------------
HER2 Positive Breast Cancer

Intervention / Treatment
-----------------
* Other: Home-based Adapted Physical Activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women > 18 years old Patient with HER2 (Human Epidermal growth factor Receptor 2) positive breast cancer histologically proven, eligible for neoadjuvant chemotherapy and targeted therapy against HER-2 Affiliation to the French social security scheme Patient who signed the participation consent before entering the trial Medical fitness certificate for sport Exclusion Criteria: Diagnosis of a second malignancy in the past 5 years, with the exception of a basal cell skin cancer Metastatic cancer Karnofsky index ≤ 90% Men Pregnant women Significant psychiatric or neurological abnormality Patient deprived of liberty by a court or administrative Contraindication for physical activity Patient unable to complete questionnaires (language barrier) Participation in a clinical trial with the same objective

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional<br>Home-Based Adapted Physical Activity intervention during neoadjuvant chemotherapy : 150 minutes per week of aerobic and muscle strengthening exercises during 18 weeks | Other: Home-based Adapted Physical Activity<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, HER2+, Adapted physical activity, Neoadjuvant chemotherapy