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

Breast Cancer Clinical Trial

— PROTECT-04  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04639609
• Other study ID #: 2020-007
• Secondary ID: 2020-A01272-37
• Status: Completed
• Phase: N/A
• Start date: September 29, 2020
• Est. completion date: September 6, 2021

Study information

• Verified date: September 2021
• Source: Institut de cancérologie Strasbourg Europe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 6, 2021
• Est. primary completion date: September 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria :

Group 1 - Patients :

• 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:

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Characterization of Neuromuscular Function and Fatigue
at inclusion

Locations

Country	Name	City	State
France	Institut de Cancerologie Strasbourg Europe	Strasbourg

Sponsors (2)

Lead Sponsor	Collaborator
Institut de cancérologie Strasbourg Europe	UR 3072 - Mitochondrie, Stress oxydant et Protection musculaire

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal isometric muscle strength for knee extensors	Measured with force sensors. Significant differences between the two groups will be assessed	At Inclusion
Secondary	Number of Participants with neuromuscular fatigue	Assessment using surface electromyography. Significant differences between the two groups will be assessed.	At Inclusion
Secondary	Number of Participants with neuromuscular fatigue	Assessment using percutaneous electric nerve stimulation. Significant differences between the two groups will be assessed.	At Inclusion
Secondary	Number of Participants with neuromuscular fatigue	Assessment using transcranial magnetic stimulation. Significant differences between the two groups will be assessed.	At Inclusion
Secondary	Number of Participants with subjective fatigue.	Questionnaire Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F) version 4.; Significant differences between the two groups will be assessed.	At Inclusion
Secondary	Number of Participants with muscle architecture.	Assessment using muscle ultrasonography. Significant differences between the two groups will be assessed.	At Inclusion
Secondary	Number of Participants with body composition.	Assessment using bio-impedance analysis. Significant differences between the two groups will be assessed.	At Inclusion