Status:
UNKNOWN
A Physical Activity Program to Improve Quality of Life and Reduce Fatigue in Metastatic Breast Cancer
Lead Sponsor:
Centre Leon Berard
Collaborating Sponsors:
Fondation ARC
Janssen, LP
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 fe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT04354233
Start Date
June 24 2020
End Date
June 1 2025
Last Update
August 21 2024
Active Locations (18)
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1
CHU Amiens
Amiens, France
2
Institut de Cancérologie de l'Ouest (ICO)
Angers, France
3
CHU Avignon
Avignon, France
4
CH Fleyriat
Bourg-en-Bresse, France