Adapted Physical Activity for Breast Cancer HER2 Positive Patient
Not Applicable
Terminated
- Conditions
- HER2 Positive Breast Cancer
- Interventions
- Other: Home-based Adapted Physical Activity
- Registration Number
- NCT02963363
- Lead Sponsor
- Centre Jean Perrin
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 36
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Interventional Home-based Adapted Physical Activity Home-Based Adapted Physical Activity intervention during neoadjuvant chemotherapy : 150 minutes per week of aerobic and muscle strengthening exercises during 18 weeks
- Primary Outcome Measures
Name Time Method Rate of patients reaching international physical activity recommendations for post-neoadjuvant chemotherapy assessment Change from baseline (T0: before neoadjuvant chemotherapy) at the 5 months (T1: end of neoadjuvant chemotherapy) Time spent to physical activity and sedentariness will be evaluated by Recent Physical Activity Questionnaire (RPAQ)
- Secondary Outcome Measures
Name Time Method Physical capacity : VO2max 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 This measure is optional
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 Anthropometrics measurements 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 Hip circumference (cm)
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 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 At each cycle of neoadjuvant chemotherapy : every three weeks during 5 months frequency of dose reduction (%), of postponement (%) or of treatment discontinuation (%)
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 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 Assessment of physical activity level using a validated smartphone application (eMouveRecherche) 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 Including sedentariness time
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 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
Trial Locations
- Locations (1)
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France