MedDataX Logo

Adapted Physical Activity for Breast Cancer HER2 Positive Patient

NCT ID: NCT02963363

Last Updated: 2023-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-27

Study Completion Date

2023-08-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HER2 Positive Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Interventional

Home-Based Adapted Physical Activity intervention during neoadjuvant chemotherapy :

150 minutes per week of aerobic and muscle strengthening exercises during 18 weeks

Group Type EXPERIMENTAL

Home-based Adapted Physical Activity

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Jean Perrin

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Xavier DURANDO, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Jean Perrin

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre Jean Perrin

Clermont-Ferrand, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34966667 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2016-A01344-47

Identifier Type: -

Identifier Source: org_study_id