Characterization of Neuromuscular Function and Fatigue After Breast Cancer Treated With Adjuvant Chemotherapy (PROTECT-04)
NCT ID: NCT04639609
Last Updated: 2021-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2020-09-29
2021-09-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Group 1 : Patients
Characterization of Neuromuscular Function and Fatigue
at inclusion
Group 2 : healthy volunteers
Characterization of Neuromuscular Function and Fatigue
at inclusion
Interventions
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Characterization of Neuromuscular Function and Fatigue
at inclusion
Eligibility Criteria
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Inclusion Criteria
* Give written inform consent
* Age ≥ 18 years
* Affiliate to social security system
* Ability to speak, understand and read French
* Breast cancer, Stage II or III, treated by taxane-based chemotherapy
Group 2 - Control group :
* Give written inform consent
* Age ≥ 18 years
* Affiliate to social security system
* Ability to speak, understand and read French
Exclusion Criteria
* \< 18 years old or patients ≥ 18 years old under guardianship, or supervision
* Psychiatric, musculoskeletal or neurologic disorders
* Patients presenting one of the following contraindications to transcranial magnetic stimulation :
* Presence of a implanted metallic foreign-body (cochlear implant, drug pump system, pacemaker, etc.)
* History of epilepsy
* Brain injury (vascular, traumatic, tumour-induced, infectious or metabolic)
* Women that are pregnant
* Serious or recent heart disease
Group 2 -Control group :
* \< 18 years old or patients ≥ 18 years old under guardianship, or supervision
* Psychiatric, musculoskeletal or neurologic disorders
* Pacemaker implantation
* History of cancer
* All known chronic disease
* Subjects presenting one of the following contraindications to transcranial magnetic stimulation :
* Presence of a implanted metallic foreign-body (cochlear implant, drug pump system, pacemaker, etc.)
* History of epilepsy
* Brain injury (vascular, traumatic, tumour-induced, infectious or metabolic)
* Women that are pregnant
* Serious or recent heart disease
18 Years
FEMALE
Yes
Sponsors
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UR 3072 - Mitochondrie, Stress oxydant et Protection musculaire
UNKNOWN
Institut de cancérologie Strasbourg Europe
OTHER
Responsible Party
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Locations
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Institut de Cancerologie Strasbourg Europe
Strasbourg, , France
Countries
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References
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Hucteau E, Mallard J, Pivot X, Schott R, Pflumio C, Trensz P, Favret F, Pagano AF, Hureau TJ. Exacerbated central fatigue and reduced exercise capacity in early-stage breast cancer patients treated with chemotherapy. Eur J Appl Physiol. 2023 Jul;123(7):1567-1581. doi: 10.1007/s00421-023-05177-5. Epub 2023 Mar 20.
Other Identifiers
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2020-A01272-37
Identifier Type: OTHER
Identifier Source: secondary_id
2020-007
Identifier Type: -
Identifier Source: org_study_id
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