Metastatic BreastcancerABLENCT03148886
Advanced Breast Cancer and Lifestyle Exercise Study
A study testing PA intervention in people with Metastatic Breastcancer, run by Centre Leon Berard at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 78 years, women only
- Conditions the study is for
- Metastatic Breastcancer
- What is being tested?
- PA intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2016to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 78 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this 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.
- Conditions
- Metastatic Breastcancer
- Being tested
- PA intervention
- Keywords
- Physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PA interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PA intervention | Experimental | The intervention consisted in a home-based adapted PA program defined at the inclusion, according to patient's capacities. Receives: Other: PA intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving the physical activity program recommendations
150 min per week of moderate PA assessed by the IPAQ
Measured: 6 months
Secondary outcomes (14)
Variation of oxidative stress
7mL blood sample is collected at baseline and at the end of the study
Measured: 6 months
Investigate the effects of a PA intervention on fitness level
IPAQ in MET-min per week
Measured: 6 months
Investigate the effects of a PA intervention on fitness level
6-min walk test in meters
Measured: 6 months
Investigate the effects of a PA intervention on fitness level
VO2 peak in ml per kg per minute
Measured: 6 months
Investigate the effects of a PA intervention on fitness level
strength test in kilograms
Measured: 6 months
Investigate the effects of a PA intervention on quality of life
EORTC QLQ-C30
Measured: 6 months
Investigate the effects of a PA intervention on quality of life
BR-23
Measured: 6 months
Investigate the effects of a PA intervention on fatigue
PIPER scale
Measured: 6 months
Investigate the effects of a PA intervention on social deprivation
EPICES score
Measured: 6 months
Investigate the barriers and facilitators of adherence to a PA program
Specific questionnaire
Measured: 6 months
Investigate the effects of a PA intervention on changes in anthropometrics
BMI in kilograms per m²
Measured: 6 months
Investigate the effects of a PA intervention on changes in anthropometrics
waist circumference in centimeters
Measured: 6 months
Investigate the effects of a PA intervention on changes in anthropometrics
Weight in kilograms
Measured: 6 months
Investigate the effects of a PA intervention on changes in anthropometrics
Hip circumference in centimeters
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study startOct 2016
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Metastatic BreastcancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Collaborators
- Claude Bernard University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148886
- Sponsor's protocol ID
- ABLE
- Acronym
- ABLE
- Status last verified
- Jul 2018
- First submitted
- 5 May 2017
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34326920Delrieu 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.
PubMed 32012082Delrieu 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.
PubMed 31571315Delrieu 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.
PubMed 30166274
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Breast Cancer and Lifestyle Exercise Study
- ClinicalTrials.gov ID
- NCT03148886
- Acronym / sponsor ID
- ABLE / ABLE
- Conditions
- Metastatic Breastcancer
- Keywords
- Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Collaborators
- Claude Bernard University
- Study start
- Oct 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 11 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PA intervention | Experimental | Other: PA interventionThe intervention consisted in a home-based adapted PA program defined at the inclusion, according to patient's capacities. |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PA interventionThe 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. | Other | PA intervention |
Primary outcome
Proportion of patients achieving the physical activity program recommendations
Time frame: 6 months
150 min per week of moderate PA assessed by the IPAQ
14 secondary outcomes
Variation of oxidative stress
Time frame: 6 months
Investigate the effects of a PA intervention on fitness level
Time frame: 6 months
Investigate the effects of a PA intervention on fitness level
Time frame: 6 months
Investigate the effects of a PA intervention on fitness level
Time frame: 6 months
Investigate the effects of a PA intervention on fitness level
Time frame: 6 months
Investigate the effects of a PA intervention on quality of life
Time frame: 6 months
Investigate the effects of a PA intervention on quality of life
Time frame: 6 months
Investigate the effects of a PA intervention on fatigue
Time frame: 6 months
Investigate the effects of a PA intervention on social deprivation
Time frame: 6 months
Investigate the barriers and facilitators of adherence to a PA program
Time frame: 6 months
Investigate the effects of a PA intervention on changes in anthropometrics
Time frame: 6 months
Investigate the effects of a PA intervention on changes in anthropometrics
Time frame: 6 months
Investigate the effects of a PA intervention on changes in anthropometrics
Time frame: 6 months
Investigate the effects of a PA intervention on changes in anthropometrics
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Derived from this study: PubMed 34326920Delrieu 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.
- Derived from this study: PubMed 32012082Delrieu 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.
- Derived from this study: PubMed 31571315Delrieu 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.
- Derived from this study: PubMed 30166274Delrieu 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.
- Individual participant dataSharing planned: No
Related trials for Metastatic Breastcancer
Not yet recruiting
Fit2ThriveMB: Optimization of a Physical Activity Promotion Intervention for Metastatic Breast Cancer Patients
Metastatic Breast Cancer, Metastatic Breast Cancer (MBC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PA intervention in people with Metastatic Breastcancer, run by Centre Leon Berard at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving the physical activity program recommendations (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03148886, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2018.