HER2 Positive Breast Cancer
Conditions
Keywords
Breast cancer, HER2+, Adapted physical activity, Neoadjuvant chemotherapy
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.
Interventions
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
Sponsors
Centre Jean Perrin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | BMI |
| 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 | — |
| 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 | — |
| 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 | At each cycle of neoadjuvant chemotherapy : every three weeks during 5 months | frequency of dose reduction (%), of postponement (%) or of treatment discontinuation (%) |
| 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 |
| 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 |
Countries
France
Outcome results
None listed