Institut de Cancerologie Strasbourg Europe
Strasbourg, 67033, France
NCT Number: NCT04638712
This is an interventional, prospective and monocentric study. This study includes the evaluation before and after (neo)adjuvant therapy of :
* one group of patients receiving anthracyclines and taxanes * a second group of patients receiving anthracyclines, taxanes and trastuzumab.
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Notify Me18 year and older
Female
Interventional
Not applicable
Strasbourg, 67033, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For group 1 without trastuzumab :
For group 2 with trastuzumab :
Exclusion criteria
before and after chemotherapy
before and after chemotherapy
Time frame: Between Week 18 and 24 after chemotherapy
Measured from muscle microbiopsy sample
Time frame: Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
Assessment using bio-impedance analysis
Time frame: Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
Assessment of maximal isometric muscle strength for knee extensors measured with force sensors.
Time frame: Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
Assessment using muscle ultrasonography
Time frame: Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
Self-assessment questionnaire Functional Assessment of Cancer Therapy - General (FACT-G) (version 3)
Time frame: Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
Questionnaire Functional Assessment of Anorexia/Cachexia Therapy (FAACT) (version 4)
Institut de cancérologie Strasbourg Europe
Other
Acronym: PROTECT-03
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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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