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

Sponsor

Institut de cancérologie Strasbourg Europe (Other)

Overall Status

Completed

CT.gov ID

NCT04639609

Collaborator

UR 3072 - Mitochondrie, Stress oxydant et Protection musculaire (Other)

Enrollment

Location

Arms

11.2

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Other: Characterization of Neuromuscular Function and Fatigue	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Sep 29, 2020

Actual Primary Completion Date :

Sep 6, 2021

Actual Study Completion Date :

Sep 6, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Number of Participants with neuromuscular fatigue [At Inclusion]
Assessment using surface electromyography. Significant differences between the two groups will be assessed.
Number of Participants with neuromuscular fatigue [At Inclusion]
Assessment using percutaneous electric nerve stimulation. Significant differences between the two groups will be assessed.
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 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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut de Cancerologie Strasbourg Europe	Strasbourg		France	67033

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institut de cancérologie Strasbourg Europe

ClinicalTrials.gov Identifier:

NCT04639609

Other Study ID Numbers:

2020-007
2020-A01272-37

First Posted:

Nov 20, 2020

Last Update Posted:

Sep 28, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Sep 28, 2021