Advanced Breast Cancer and Lifestyle Exercise Study

Metastatic Breastcancer Clinical Trial

— ABLE  

Official title:

Advanced Breast Cancer and Lifestyle Exercise Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03148886
• Other study ID #: ABLE
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: January 2018

Study information

• Verified date: July 2018
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 78 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breastcancer

Intervention

Other:
• PA intervention
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.

Locations

Country	Name	City	State
France	Centre Léon Bérard	Lyon

Sponsors (2)

Lead Sponsor	Collaborator
Centre Leon Berard	Claude Bernard University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients achieving the physical activity program recommendations	150 min per week of moderate PA assessed by the IPAQ	6 months
Secondary	Variation of oxidative stress	7mL blood sample is collected at baseline and at the end of the study	6 months
Secondary	Investigate the effects of a PA intervention on fitness level	IPAQ in MET-min per week	6 months
Secondary	Investigate the effects of a PA intervention on fitness level	6-min walk test in meters	6 months
Secondary	Investigate the effects of a PA intervention on fitness level	VO2 peak in ml per kg per minute	6 months
Secondary	Investigate the effects of a PA intervention on fitness level	strength test in kilograms	6 months
Secondary	Investigate the effects of a PA intervention on quality of life	EORTC QLQ-C30	6 months
Secondary	Investigate the effects of a PA intervention on quality of life	BR-23	6 months
Secondary	Investigate the effects of a PA intervention on fatigue	PIPER scale	6 months
Secondary	Investigate the effects of a PA intervention on social deprivation	EPICES score	6 months
Secondary	Investigate the barriers and facilitators of adherence to a PA program	Specific questionnaire	6 months
Secondary	Investigate the effects of a PA intervention on changes in anthropometrics	BMI in kilograms per m²	6 months
Secondary	Investigate the effects of a PA intervention on changes in anthropometrics	waist circumference in centimeters	6 months
Secondary	Investigate the effects of a PA intervention on changes in anthropometrics	Weight in kilograms	6 months
Secondary	Investigate the effects of a PA intervention on changes in anthropometrics	Hip circumference in centimeters	6 months