Advanced Breast Cancer and Lifestyle Exercise Study (ABLE)

Léon Bérard Center

Status: Completed

Conditions: Metastatic Breastcancer

Treatments: Other: PA intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03148886

ABLE

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: Female

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

PA intervention

Experimental group

Description:

The intervention consisted in a home-based adapted PA program defined at the inclusion, according to patient's capacities.

Treatment:

Other: PA intervention