Clinical trial NCT04354233: A Physical Activity Program to Improve Quality of Life and Reduce Fatigue in Metastatic Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metastatic Breast Cancer
Keywords: Metastatic breast cancer
Physical activity
Connected devices
e-Health
Quality of life
Fatigue
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
Collaborators: name: Fondation ARC
name: Janssen, LP
First posted: 2020-04-21
Enrollment: 244
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: At the first visit of the study, participants will be randomly assigned (1:1 ratio), with minimization based on the presence of visceral metastases (presence vs. absence of visceral metastases), the method of administration of chemotherapy (intravenous vs. per os) and the 6-minute walking distance (6MWD) (\<455 versus ≥ 455m based on the median of the pilot ABLE study) to: (i) the intervention arm to receive PA recommendations and benefit from a 6-month APA program (ii) the control arm to receive PA recommendations only.
Primary purpose: SUPPORTIVE_CARE

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 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.


Eligibility 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.

Primary outcomes:
measure: time to deterioration of global health status (GHS) score of EORTC QLQ C30
timeFrame: Month 18
measure: time to deterioration of fatigue score of EORTC QLQ C30
timeFrame: Month 18
Secondary outcomes:
measure: Overall survival
timeFrame: Month 18
measure: Progression free survival
timeFrame: Month 18
measure: Other dimensions of health-related quality of life of the EORTC QLQ C30
timeFrame: Baseline, Month 3, Month 6, Month 12
measure: Fatigue
timeFrame: Baseline, Month 3, Month 6, Month 12
measure: Proportion of patients who change their physical condition (6-min walking distance)
timeFrame: Change between baseline, Month 3, Month 6 and Month 12
measure: Proportion of patients who change their physical condition (sit-to-stand)
timeFrame: Change between baseline, Month 3, Month 6 and Month 12
measure: Proportion of patients who change their physical condition (handgrip strength)
timeFrame: Change between baseline, Month 3, Month 6 and Month 12
measure: Proportion of patients who change their weight
timeFrame: Change between baseline, Month 3, Month 6 and Month 12
measure: Proportion of patients who change their waist circumference
timeFrame: Change between baseline, Month 3, Month 6 and Month 12
measure: Proportion of patients who change their hip circumference
timeFrame: Change between baseline, Month 3, Month 6 and Month 12
measure: Proportion of patients who change their physical activity level
timeFrame: Change between baseline, Month 3, Month 6 and Month 12
measure: Proportion of patients who change sleep disorders
timeFrame: Change between baseline and Month 6
measure: Proportion of patients who loss muscle mass (sarcopenia)
timeFrame: Change between baseline, Month 3, Month 6, Month 12 and at first progression up to Month 18
measure: Proportion of patients who change their dietary patterns
timeFrame: Change between baseline and Month 6
measure: Proportion of patients who have severe toxicity (grade > 2)
timeFrame: Month 12
measure: Proportion of patients who have modifications in inflammation and sarcopenia according to blood sample analysis
timeFrame: Change between baseline, Month 3, Month 6, Month 12 and at first progression up to Month 18
measure: Proportion of patients who have modifications on oxidative stress according to blood sample analysis
timeFrame: Change between baseline, Month 3, Month 6, Month 12 and at first progression up to Month 18
measure: Proportion of patients who modify their personnality factors
timeFrame: Change between baseline and Month 6
measure: Proportion of patients who modify their behaviour in association with physical activity
timeFrame: Change between baseline and Month 6
measure: Proportion of patients who accept the connected device (in the intervention arm only)
timeFrame: Month 6
measure: Proportion of patients who are compliant to the PA intervention (in the intervention arm only)
timeFrame: Month 6
measure: Proportion of patients who modify their cognition
timeFrame: Change between baseline, Month 6 and Month 12
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Angers
country: France
facility: Institut de Cancérologie de l'Ouest (ICO)
city: Avignon
country: France
facility: CHU Avignon
city: Bourg-en-Bresse
country: France
facility: CH Fleyriat
city: Cherbourg
country: France
facility: CH Cotentin
city: Cholet
country: France
facility: CH Cholet
city: Dijon
country: France
facility: CGFL
city: Grenoble
country: France
facility: Groupement Hospitalier Mutualiste
city: Lyon
country: France
facility: Centre Léon Bérard (CLB)
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Morlaix
country: France
facility: CH Morlaix
city: Paris
country: France
facility: AP-HP
city: Paris
country: France
facility: Institut Curie
city: Reims
country: France
facility: Institut Godinot
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Saint-Herblain
country: France
facility: Institut de Cancérologie de l'Ouest (ICO)
city: Saint-Étienne
country: France
facility: Institut de Cancérologie Lucien Neuwirth (ICLN)
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Centre Leon Berard
name: Olivier TREDAN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Delrieu L, Anota A, Tredan O, Freyssenet D, Maire A, Canada B, Fournier B, Febvey-Combes O, Pilleul F, Bouhamama A, Caux C, Joly F, Fervers B, Pialoux V, Perol D, Perol O. Design and methods of a national, multicenter, randomized and controlled trial to assess the efficacy of a physical activity program to improve health-related quality of life and reduce fatigue in women with metastatic breast cancer: ABLE02 trial. BMC Cancer. 2020 Jul 3;20(1):622. doi: 10.1186/s12885-020-07093-9.