Clinical trial NCT03148886: Advanced Breast Cancer and Lifestyle Exercise Study
Official title: Advanced Breast Cancer and Lifestyle Exercise Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Breastcancer
Keywords: Physical activity
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
Collaborators: name: Claude Bernard University
First posted: 2017-05-11
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: About 5% of breast cancers are metastatic at diagnosis and 20-30% of localized breast cancer become secondarily metastatic.Thanks to recent therapeutic advances, the median survival ranges between 12 months in 1970 and 18 to 24 months in 2000. However, patients suffer from many detrimental symptoms such as fatigue, pain related to treatment and metastasis. The physical, biological, psychological and clinical benefits of physical activity (PA) during treatment in patients with localized breast cancer have been widely demonstrated. Numerous studies investigated the effect of PA in non-metastatic breast cancer, but to our knowledge, only four interventional studies worldwide focused on the implementation of PA in patients with metastatic breast cancer.It seems appropriate to investigate the feasibility of PA intervention with patients with metastatic breast cancer to see if the observed effects in localized breast cancer are confirmed in metastatic breast cancer population. The ABLE study is an interventional cohort designed to assess the feasibility of a 6-month adapted physical activity intervention, performed under real life conditions in patients with metastatic breast cancer.


Eligibility criteria: Inclusion Criteria:

* aged 18 to 78 years old,
* newly diagnosed with a metastatic breast cancer (i.e. within the last 3 months)
* treated in the CLB by chemotherapy, and/or radiotherapy and/or hormonotherapy and/or targeted therapy.
* ECOG Performance status \<2,
* being French-speaking
* able to complete questionnaires and follow instructions in French
* valid health insurance affiliation.
* medical certificate of no contraindications to exercise physical activity

Exclusion Criteria:

* untreated brain metastases
* uncontrolled cardiac disease,
* contraindications to PA,
* unable to be followed for medical, social, familial, geographical or psychological reasons over the study duration,
* deprivation of liberty by court or administrative decision
* pregnancy

Primary outcomes:
measure: Proportion of patients achieving the physical activity program recommendations
timeFrame: 6 months
Secondary outcomes:
measure: Variation of oxidative stress
timeFrame: 6 months
measure: Investigate the effects of a PA intervention on fitness level
timeFrame: 6 months
measure: Investigate the effects of a PA intervention on fitness level
timeFrame: 6 months
measure: Investigate the effects of a PA intervention on fitness level
timeFrame: 6 months
measure: Investigate the effects of a PA intervention on fitness level
timeFrame: 6 months
measure: Investigate the effects of a PA intervention on quality of life
timeFrame: 6 months
measure: Investigate the effects of a PA intervention on quality of life
timeFrame: 6 months
measure: Investigate the effects of a PA intervention on fatigue
timeFrame: 6 months
measure: Investigate the effects of a PA intervention on social deprivation
timeFrame: 6 months
measure: Investigate the barriers and facilitators of adherence to a PA program
timeFrame: 6 months
measure: Investigate the effects of a PA intervention on changes in anthropometrics
timeFrame: 6 months
measure: Investigate the effects of a PA intervention on changes in anthropometrics
timeFrame: 6 months
measure: Investigate the effects of a PA intervention on changes in anthropometrics
timeFrame: 6 months
measure: Investigate the effects of a PA intervention on changes in anthropometrics
timeFrame: 6 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Léon Bérard
Study officials:
References:
citation: Delrieu L, Touillaud M, Perol O, Morelle M, Martin A, Friedenreich CM, Mury P, Dufresne A, Bachelot T, Heudel PE, Fervers B, Tredan O, Pialoux V. Impact of Physical Activity on Oxidative Stress Markers in Patients with Metastatic Breast Cancer. Oxid Med Cell Longev. 2021 Jul 16;2021:6694594. doi: 10.1155/2021/6694594. eCollection 2021.
citation: Delrieu L, Pialoux V, Perol O, Morelle M, Martin A, Friedenreich C, Febvey-Combes O, Perol D, Belladame E, Clemencon M, Roitmann E, Dufresne A, Bachelot T, Heudel PE, Touillaud M, Tredan O, Fervers B. Feasibility and Health Benefits of an Individualized Physical Activity Intervention in Women With Metastatic Breast Cancer: Intervention Study. JMIR Mhealth Uhealth. 2020 Jan 28;8(1):e12306. doi: 10.2196/12306.
citation: Delrieu L, Vallance JK, Morelle M, Fervers B, Pialoux V, Friedenreich C, Dufresne A, Bachelot T, Heudel PE, Tredan O, Perol O, Touillaud M. Physical activity preferences before and after participation in a 6-month physical activity intervention among women with metastatic breast cancer. Eur J Cancer Care (Engl). 2020 Jan;29(1):e13169. doi: 10.1111/ecc.13169. Epub 2019 Sep 30.
citation: Delrieu L, Perol O, Fervers B, Friedenreich C, Vallance J, Febvey-Combes O, Perol D, Canada B, Roitmann E, Dufresne A, Bachelot T, Heudel PE, Tredan O, Touillaud M, Pialoux V. A Personalized Physical Activity Program With Activity Trackers and a Mobile Phone App for Patients With Metastatic Breast Cancer: Protocol for a Single-Arm Feasibility Trial. JMIR Res Protoc. 2018 Aug 30;7(8):e10487. doi: 10.2196/10487.