Clinical trial NCT02963363: Adapted Physical Activity for Breast Cancer HER2 Positive Patient
Official title: Feasibility Study of an Adapted Physical Activity (APA) for Breast Cancer Patients Treated by Neoadjuvant Chemotherapy and Targeted Therapy Against HER2
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: HER2 Positive Breast Cancer
Keywords: Breast cancer
HER2+
Adapted physical activity
Neoadjuvant chemotherapy
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
First posted: 2016-11-15
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Rate of patients reaching international physical activity recommendations for post-neoadjuvant chemotherapy assessment
timeFrame: Change from baseline (T0: before neoadjuvant chemotherapy) at the 5 months (T1: end of neoadjuvant chemotherapy)
Secondary outcomes:
measure: Longitudinal evolution of RPAQ score
timeFrame: 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
measure: Quality of life : Quality of Life Questionnaire-C30
timeFrame: 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
measure: Asthenia : Multidimensional Fatigue Inventory-20
timeFrame: 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
measure: Anthropometrics measurements
timeFrame: 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
measure: Anthropometrics measurements
timeFrame: 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
measure: Physical capacity : six-minutes walking distance test
timeFrame: 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
measure: Physical capacity : Voluntary muscular strength
timeFrame: 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
measure: Physical capacity : VO2max
timeFrame: 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
measure: Lipid profile : total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides
timeFrame: 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
measure: Ventricular ejection fraction assessed by echocardiography or cardiac scintigraphy
timeFrame: 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
measure: Changes of cancer treatment
timeFrame: At each cycle of neoadjuvant chemotherapy : every three weeks during 5 months
measure: Assessment of physical activity level using a validated smartphone application (eMouveRecherche)
timeFrame: 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
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
Study officials:
affiliation: Centre Jean Perrin
name: Xavier DURANDO, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.