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Clinical Trials/NCT04639609
NCT04639609
Completed
Not Applicable

Characterization of Neuromuscular Function and Fatigue After Breast Cancer Treated With Adjuvant Chemotherapy

Institut de cancérologie Strasbourg Europe1 site in 1 country30 target enrollmentSeptember 29, 2020
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Institut de cancérologie Strasbourg Europe
Enrollment
30
Locations
1
Primary Endpoint
Maximal isometric muscle strength for knee extensors
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

This is a transversal monocentric study comparing two groups of women (group 1, patient group : patients who have been treated for a breast cancer with taxane-based chemotherapy ; group 2, control group : healthy volunteers). The aim of this study is to evaluate if a difference exists regarding the maximal isometric muscle strength between group 1 and 2.

Detailed Description

All subjects will be evaluated a single time during two hours. For patients from group 1 the evaluation should take place within the two weeks that follow the end of adjuvant treatment. There is no specificity regarding evaluation of volunteers from group 2, their evaluation can take place at any time.

Registry
clinicaltrials.gov
Start Date
September 29, 2020
End Date
September 6, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Institut de cancérologie Strasbourg Europe
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Group 1 - Patients :
  • \< 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 :

Outcomes

Primary Outcomes

Maximal isometric muscle strength for knee extensors

Time Frame: At Inclusion

Measured with force sensors. Significant differences between the two groups will be assessed

Secondary Outcomes

  • Number of Participants with neuromuscular fatigue(At Inclusion)
  • Number of Participants with muscle architecture.(At Inclusion)
  • Number of Participants with body composition.(At Inclusion)
  • Number of Participants with subjective fatigue.(At Inclusion)

Study Sites (1)

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