NCT04354233Completed
A Physical Activity Program to Improve Quality of Life and Reduce Fatigue in Metastatic Breast Cancer
A National, Multicenter, Randomized Controlled Trial to Assess the Efficacy of a Physical Activity Program to Improve Quality of Life and Reduce Fatigue in Women With Metastatic Breast Cancer
Source: ClinicalTrials.gov · Last updated 4 May 2026
Brief summary (registry, in English)
INTRODUCTION: Patients with a metastatic breast cancer suffer from a deteriorated quality of life and numerous symptoms such as pain, severe fatigue and a decrease of their physical fitness. As the feasibility of a physical activity program has been demonstrated in this population, ABLE02 aims to assess the efficacy of a 6 month-physical activity program based on connected devices to improve health-related quality of life and to reduce fatigue in women with metastatic breast cancer. METHODS/ANALYSIS: ABLE02 is a prospective, multicenter, randomized, controlled and, open-label study. 244 patients with a metastatic breast cancer , at least one positive hormone receptor and a first-line chemotherapy planned will be randomly assigned (1:1 ratio) to: (i) the intervention arm to receive physical activity recommendations, an activity tracker to wear 24 hours a day during the whole intervention (6 months) with at least three walking sessions weekly and quizzes to answer each week on physical activity and nutrition (ii) the control arm to receive physical activity recommendations only. Assessments will be conducted at baseline, M3, M6, M12 and M18 to evaluate the clinical, physical, biological and psychological parameters and survival of participants. All questionnaires will be completed on a dedicated application. DISCUSSION: An activity program based on smartphone application linked to an activity tracker may help to improve quality of life and reduce fatigue of patients with a metastatic breast cancer. The growth of e-health offers the opportunity to get real-time data as well as improving patient empowerment in order to change long-term behaviors.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 124 (actual)
- First submitted
- 14 Apr 2020
- Start date
- 24 Jun 2020
- Primary completion date
- 30 Jun 2024
- Lead sponsor
- Centre Leon Berard
- Diseases
- Metastatic breast cancer
- NCT number
- NCT04354233
What you commit to
- Study type: Interventional
- Participants enrolled: 124
- From 24 Jun 2020 to the primary completion date, 30 Jun 2024
- 18 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 6\) concurrent participation in another PA study,
Other illness
- 3\) presence of a history or co-existence of other primary cancer (except of in situ cancer regardless of the site and/or basal cell skin cancer and/or non-mammary cancer in complete remission for more than 5 years),
- 5\) presenting a PA contraindication (e.g., uncontrolled hypertension, uncontrolled heart disease),
Age
- 4\) severe undernutrition (HAS) (i.e. for women ≤ 70 years old: a weight loss of ≥ 15% in 6 months or ≥10% in 1 month and for women over 70 years old: a weight loss of ≥ 15% in 6 months or ≥10% in 1 month, and body mass index \<18 kg/m²),
Other
- 1\) presence of unstable bone metastases or unconsolidated pathological fractures,
- 2\) presence of central nervous system involvement with neurological deficits that prevent from walking,
- 7\) unable to be followed for medical, social, family, geographical or psychological reasons throughout the study,
- 8\) deprived of liberty by judicial or administrative decision,
- 9\) pregnant.
Who the study is looking for
- 1\) female,
- 2\) ≥ 18 years old,
- 3\) histologically confirmed metastatic breast cancer, with at least one positive hormone receptor (HR+) and HER2-,
- 4\) first-line chemotherapy planned (or until 1 month after the chemotherapy has started) with intravenous (Paclitaxel or Doxorubicin or Cyclophosphamide or Carboplatin) or per os (Capecitabine or Vinorelbine) administration - NB : a patient who has previously received one or more lines of hormone therapy and who must start a 1st line of chemotherapy is eligible,
- 5\) Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2,
- 6\) life expectancy ≥ 3 months,
- 7\) willing to be involved throughout the study,
- 8\) ability to practice a adapted physical activity (APA) certified by a medical certificate issued by the referring oncologist or the clinical investigator,
- 9\) using a compatible smartphone or Tablet PC to download the application ABLE02 and Withings Health Mate (from iOS 10 and android 6.0 and more recent),
- 10\) Internet access,
- 11\) valid health insurance affiliation,
- 12\) able to read, write and understand French.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Amiens Coordinator of this site? Confirm its status | Amiens | France | Unknown status |
| Institut de Cancérologie de l'Ouest (ICO) Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| CHU Avignon Coordinator of this site? Confirm its status | Avignon | France | Unknown status |
| CH Fleyriat Coordinator of this site? Confirm its status | Bourg-en-Bresse | France | Unknown status |
| CH Cotentin Coordinator of this site? Confirm its status | Cherbourg | France | Unknown status |
| CH Cholet Coordinator of this site? Confirm its status | Cholet | France | Unknown status |
| CGFL Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| Groupement Hospitalier Mutualiste Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| Centre Léon Berard (CLB) Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| CH Morlaix Coordinator of this site? Confirm its status | Morlaix | France | Unknown status |
| Institut Curie Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| AP HP Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Institut Godinot Coordinator of this site? Confirm its status | Reims | France | Unknown status |
| Centre Eugène Marquis Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| Institut de Cancérologie Lucien Neuwirth (ICLN) Coordinator of this site? Confirm its status | Saint-Etienne | France | Unknown status |
| Institut de Cancérologie de l'Ouest (ICO) Coordinator of this site? Confirm its status | Saint-Herblain | France | Unknown status |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.