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

Centre Jean Perrin1 site in 1 country36 target enrollmentApril 27, 2018

ConditionsHER2 Positive Breast Cancer

Overview

Phase: N/A
Intervention: Not specified
Conditions: HER2 Positive Breast Cancer
Sponsor: Centre Jean Perrin
Enrollment: 36
Locations: 1
Primary Endpoint: Rate of patients reaching international physical activity recommendations for post-neoadjuvant chemotherapy assessment
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

April 27, 2018

End Date

August 11, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Centre Jean Perrin

Responsible Party

Sponsor

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%
•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

Outcomes

Primary Outcomes

Rate of patients reaching international physical activity recommendations for post-neoadjuvant chemotherapy assessment

Time Frame: 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 Outcomes

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)
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)
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)
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)
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)