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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04639609
Acronym
PROTECT-04
Enrollment
30
Registered
2020-11-20
Start date
2020-09-29
Completion date
2021-09-06
Last updated
2021-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

OTHERCharacterization of Neuromuscular Function and Fatigue

at inclusion

Sponsors

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

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Maximal isometric muscle strength for knee extensorsAt InclusionMeasured with force sensors. Significant differences between the two groups will be assessed

Secondary

MeasureTime frameDescription
Number of Participants with neuromuscular fatigueAt InclusionAssessment using surface electromyography. Significant differences between the two groups will be assessed.
Number of Participants with subjective fatigue.At InclusionQuestionnaire 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 InclusionAssessment using muscle ultrasonography. Significant differences between the two groups will be assessed.
Number of Participants with body composition.At InclusionAssessment using bio-impedance analysis. Significant differences between the two groups will be assessed.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026