NCT02963363

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 15, 2016

Completed
1.4 years until next milestone

Study Start

First participant enrolled

April 27, 2018

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2022

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2023

Completed
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

4.3 years

First QC Date

November 7, 2016

Last Update Submit

November 21, 2023

Conditions

HER2 Positive Breast Cancer

Keywords

Breast cancerHER2+Adapted physical activityNeoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • 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

  • 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

  • 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

  • +7 more secondary outcomes

Study Arms (1)

Interventional

EXPERIMENTAL

Home-Based Adapted Physical Activity intervention during neoadjuvant chemotherapy : 150 minutes per week of aerobic and muscle strengthening exercises during 18 weeks

Other: Home-based Adapted Physical Activity

Interventions

Home-based Adapted Physical ActivityOTHER

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

Interventional

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Related Publications (1)

  • 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.

    PMID: 34966667DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Xavier DURANDO, MD

    Centre Jean Perrin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2016

First Posted

November 15, 2016

Study Start

April 27, 2018

Primary Completion

August 19, 2022

Study Completion

August 11, 2023

Last Updated

November 24, 2023

Record last verified: 2023-11

Locations

FR(1)