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Completed

NCT Number: NCT03148886

Advanced Breast Cancer and Lifestyle Exercise Study

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.

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Key information

Conditions

Metastatic Breastcancer Behavior Motor Activity

Age range

18 year–78 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Léon Bérard

Lyon, 69008, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PA intervention

Other

The program is individualized according to age, fitness level, place of residence, access to adapted specific training group or associations, PA preferences and wishes of each participant. Patients are informed of the recommendations in terms of PA, and the target of 150min per week in order to maintain health benefits. Patients are asked to walk at least 30 minutes per day and increase their activities into daily routine. Several individual strategies are established with the patients to attain their objectives and increase their daily life PA.

Withings® PA trackers have been used to provide an incentive effect to increase PA, to measure the number of steps per day and make people think about their PA. Patients wore a Withings Go® wristband PA tracker throughout the whole study and had in real time a feedback on their number of steps per day.

A 7 mL blood sample is collected at baseline (D1) and at the end of the 6-month study (M6) for the biological study.

Primary outcomes

  1. Proportion of patients achieving the physical activity program recommendations

    Time frame: 6 months

    150 min per week of moderate PA assessed by the IPAQ

Secondary outcomes

  1. Variation of oxidative stress

    Time frame: 6 months

    7mL blood sample is collected at baseline and at the end of the study

  2. Investigate the effects of a PA intervention on fitness level

    Time frame: 6 months

    IPAQ in MET-min per week

  3. Investigate the effects of a PA intervention on fitness level

    Time frame: 6 months

    6-min walk test in meters

  4. Investigate the effects of a PA intervention on fitness level

    Time frame: 6 months

    VO2 peak in ml per kg per minute

  5. Investigate the effects of a PA intervention on fitness level

    Time frame: 6 months

    strength test in kilograms

  6. Investigate the effects of a PA intervention on quality of life

    Time frame: 6 months

    EORTC QLQ-C30

  7. Investigate the effects of a PA intervention on quality of life

    Time frame: 6 months

    BR-23

  8. Investigate the effects of a PA intervention on fatigue

    Time frame: 6 months

    PIPER scale

  9. Investigate the effects of a PA intervention on social deprivation

    Time frame: 6 months

    EPICES score

  10. Investigate the barriers and facilitators of adherence to a PA program

    Time frame: 6 months

    Specific questionnaire

  11. Investigate the effects of a PA intervention on changes in anthropometrics

    Time frame: 6 months

    BMI in kilograms per m²

  12. Investigate the effects of a PA intervention on changes in anthropometrics

    Time frame: 6 months

    waist circumference in centimeters

  13. Investigate the effects of a PA intervention on changes in anthropometrics

    Time frame: 6 months

    Weight in kilograms

  14. Investigate the effects of a PA intervention on changes in anthropometrics

    Time frame: 6 months

    Hip circumference in centimeters

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Collaborators

  • Claude Bernard University

Registry information

Acronym: ABLE

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 11, 2017
Registry last updated
Jul 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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