Adapted Physical Activity for Breast Cancer HER2 Positive Patient

HER2 Positive Breast Cancer Clinical Trial

— APACAN2  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02963363
• Other study ID #: 2016-A01344-47
• Status: Terminated
• Phase: N/A
• Start date: April 27, 2018
• Est. completion date: August 11, 2023

Study information

• Verified date: November 2023
• Source: Centre Jean Perrin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: August 11, 2023
• Est. primary completion date: August 19, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2 Positive Breast Cancer

Intervention

Other:
• Home-based Adapted Physical Activity
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

Locations

Country	Name	City	State
France	Centre Jean Perrin	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
Centre Jean Perrin

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients reaching international physical activity recommendations for post-neoadjuvant chemotherapy assessment	Time spent to physical activity and sedentariness will be evaluated by Recent Physical Activity Questionnaire (RPAQ)	Change from baseline (T0: before neoadjuvant chemotherapy) at the 5 months (T1: end of neoadjuvant chemotherapy)
Secondary	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
Secondary	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
Secondary	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
Secondary	Anthropometrics measurements	BMI	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
Secondary	Anthropometrics measurements	Hip circumference (cm)	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
Secondary	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
Secondary	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
Secondary	Physical capacity : VO2max	This measure is optional	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
Secondary	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
Secondary	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
Secondary	Changes of cancer treatment	frequency of dose reduction (%), of postponement (%) or of treatment discontinuation (%)	At each cycle of neoadjuvant chemotherapy : every three weeks during 5 months
Secondary	Assessment of physical activity level using a validated smartphone application (eMouveRecherche)	Including sedentariness time	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