A program to enhance quality of life and reduce fatigue in women with 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
This study tests a 6-month walking program with activity trackers to see if it can help women with metastatic breast cancer feel better and less tired.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 244 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Centre Leon Berard Academic / other |
| Drugs / interventions | chemotherapy, Cyclophosphamide, Doxorubicin |
| Locations | 18 sites (Amiens and 17 other locations) |
| Trial ID | NCT04354233 on ClinicalTrials.gov |
What this trial studies
This study evaluates a 6-month physical activity program designed for women with metastatic breast cancer, utilizing connected devices to monitor and encourage participation. Patients will be randomly assigned to either receive physical activity recommendations and an activity tracker or standard care. The program aims to improve health-related quality of life and decrease fatigue through structured walking sessions and weekly quizzes. The study will involve 244 participants across multiple centers, ensuring a diverse patient population.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with histologically confirmed metastatic breast cancer, at least one positive hormone receptor, and planned first-line chemotherapy.
Not a fit: Patients who are not able to engage in adapted physical activity due to severe health limitations or those with a life expectancy of less than three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly enhance the quality of life and reduce fatigue for women undergoing treatment for metastatic breast cancer.
How similar studies have performed: Previous studies have shown the feasibility of physical activity programs in similar populations, suggesting a promising approach for improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Amiens and 17 other locations
- CHU Amiens — Amiens, France (Active_not_recruiting)
- Institut de Cancérologie de l'Ouest (ICO) — Angers, France (Enrolling_by_invitation)
- CHU Avignon — Avignon, France (Recruiting)
- CH Fleyriat — Bourg-en-Bresse, France (Recruiting)
- CH Cotentin — Cherbourg, France (Active_not_recruiting)
- CH Cholet — Cholet, France (Recruiting)
- Cgfl — Dijon, France (Enrolling_by_invitation)
- Groupement Hospitalier Mutualiste — Grenoble, France (Recruiting)
- Centre Léon Bérard (CLB) — Lyon, France (Recruiting)
- Hospices Civils de Lyon — Lyon, France (Enrolling_by_invitation)
- CH Morlaix — Morlaix, France (Terminated)
- Ap-Hp — Paris, France (Active_not_recruiting)
- Institut Curie — Paris, France (Recruiting)
- Institut Godinot — Reims, France (Recruiting)
- Centre Eugène Marquis — Rennes, France (Enrolling_by_invitation)
- Institut de Cancérologie de l'Ouest (ICO) — Saint-Herblain, France (Enrolling_by_invitation)
- Institut de Cancérologie Lucien Neuwirth (ICLN) — Saint-Étienne, France (Active_not_recruiting)
- Institut Gustave Roussy — Villejuif, France (Active_not_recruiting)
Study contacts
- Principal investigator: Olivier TREDAN, MD, PhD — Centre Leon Berard
- Study coordinator: Aurélia MAIRE, MSc
- Email: aurelia.maire@lyon.unicancer.fr
- Phone: 0469856362
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.