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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Characterization of Neuromuscular Function and Fatigue

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67033
    • Institut de cancérologie Strasbourg Europe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 : Patients	Other: Characterization of Neuromuscular Function and Fatigue; at inclusion
Other: Group 2 : healthy volunteers	Other: Characterization of Neuromuscular Function and Fatigue; at inclusion

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with neuromuscular fatigue	Assessment using surface electromyography. Significant differences between the two groups will be assessed.	At Inclusion
Number of Participants with neuromuscular fatigue	Assessment using percutaneous electric nerve stimulation. Significant differences between the two groups will be assessed.	At Inclusion
Number of Participants with neuromuscular fatigue	Assessment using transcranial magnetic stimulation. Significant differences between the two groups will be assessed.	At Inclusion
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
Number of Participants with muscle architecture.	Assessment using muscle ultrasonography. Significant differences between the two groups will be assessed.	At Inclusion
Number of Participants with body composition.	Assessment using bio-impedance analysis. Significant differences between the two groups will be assessed.	At Inclusion

Collaborators and Investigators

• Sponsor: Institut de cancérologie Strasbourg Europe
• Collaborators: UR 3072 - Mitochondrie, Stress oxydant et Protection musculaire

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2020
• Primary Completion (Actual): September 6, 2021
• Study Completion (Actual): September 6, 2021

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2020-007; 2020-A01272-37 (Other Identifier: IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No