Characterization of Neuromuscular Function and Fatigue After Breast Cancer Treated With Adjuvant Chemotherapy (PROTECT-04)

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Other: Characterization of Neuromuscular Function and Fatigue

• Registration Number: NCT04639609
• Lead Sponsor: Institut de cancérologie Strasbourg Europe

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.

Study Timeline

• Study Start: 2020-09-29
• Study First Submitted: 2020-11-02
• Study First Submitted QC: 2020-11-16
• Study First Posted: 2020-11-20
• Status Verified: 2021-09
• Primary Completion: 2021-09-06
• Study Completion: 2021-09-06
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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 :

• < 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 : healthy volunteers	Characterization of Neuromuscular Function and Fatigue	-
Group 1 : Patients	Characterization of Neuromuscular Function and Fatigue	-

Primary Outcome Measures

Name	Time	Method
Maximal isometric muscle strength for knee extensors	At Inclusion	Measured with force sensors. Significant differences between the two groups will be assessed

Secondary Outcome Measures

Name	Time	Method
Number of Participants with neuromuscular fatigue	At Inclusion	Assessment using transcranial magnetic stimulation. Significant differences between the two groups will be assessed.
Number of Participants with muscle architecture.	At Inclusion	Assessment using muscle ultrasonography. Significant differences between the two groups will be assessed.
Number of Participants with body composition.	At Inclusion	Assessment using bio-impedance analysis. Significant differences between the two groups will be assessed.
Number of Participants with subjective fatigue.	At Inclusion	Questionnaire Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F) version 4.; Significant differences between the two groups will be assessed.

Trial Locations

Locations (1)

Institut de Cancerologie Strasbourg Europe; 🇫🇷 Strasbourg, France