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Walking program shows promise for easing fatigue in metastatic breast cancer

NCT ID NCT04354233

Symptom relief Sponsor: Centre Leon Berard Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether a 6-month physical activity program using a fitness tracker could help women with metastatic breast cancer feel better and less tired. 124 women with hormone receptor-positive, HER2-negative metastatic breast cancer who were starting chemotherapy took part. Half received activity recommendations plus a tracker and weekly quizzes, while the other half got recommendations only. The goal was to see if the program could delay worsening of quality of life and fatigue.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

124 people

The number who actually took part.

Started

Jun 2020

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 1\) presence of unstable bone metastases or unconsolidated pathological fractures, * 2\) presence of central nervous system involvement with neurological deficits that prevent from walking, * 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), * 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), * 5\) presenting a PA contraindication (e.g., uncontrolled hypertension, uncontrolled heart disease), * 6\) concurrent participation in another PA study, * 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.

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Conditions

The condition(s) this trial relates to.

breast carcinoma breast neoplasm Fatigue Motor Activity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic breast cancer

Contacts and locations

Locations

  • AP-HP

    Paris, France

  • CGFL

    Dijon, France

  • CH Cholet

    Cholet, France

  • CH Cotentin

    Cherbourg, France

  • CH Fleyriat

    Bourg-en-Bresse, France

  • CH Morlaix

    Morlaix, France

  • CHU Amiens

    Amiens, France

  • CHU Avignon

    Avignon, France

  • Centre Eugène Marquis

    Rennes, France

  • Centre Léon Bérard (CLB)

    Lyon, 69008, France

  • Groupement Hospitalier Mutualiste

    Grenoble, France

  • Hospices Civils de Lyon

    Lyon, France

  • Institut Curie

    Paris, France

  • Institut Godinot

    Reims, France

  • Institut Gustave Roussy

    Villejuif, France

  • Institut de Cancérologie Lucien Neuwirth (ICLN)

    Saint-Etienne, France

  • Institut de Cancérologie de l'Ouest (ICO)

    Angers, France

  • Institut de Cancérologie de l'Ouest (ICO)

    Saint-Herblain, France

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