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

Institut de cancérologie Strasbourg Europe

Status: Completed

Conditions: Breast Cancer

Treatments: Other: Characterization of Neuromuscular Function and Fatigue

Study type: Interventional

Funder types: Other

Identifiers

NCT04639609

2020-007

2020-A01272-37 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Group 1 : Patients

Experimental group

Treatment:

Other: Characterization of Neuromuscular Function and Fatigue

Group 2 : healthy volunteers

Other group

Treatment:

Other: Characterization of Neuromuscular Function and Fatigue