Adapted Physical Activity for Breast Cancer HER2 Positive Patient

Not Applicable

Terminated

• Conditions: HER2 Positive Breast Cancer

• 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.

Study Timeline

• Study First Submitted: 2016-11-07
• Study First Submitted QC: 2016-11-14
• Study First Posted: 2016-11-15
• Study Start: 2018-04-27
• Primary Completion: 2022-08-19
• Study Completion: 2023-08-11
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-24

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

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