Clinical trial · Interventional
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
NCT04639609CI-TRIAL-00054130PROTECT-04completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Characterization of Neuromuscular Function and Fatigue | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1 : Patients
- interventionNames
- Other: Characterization of Neuromuscular Function and Fatigue
- type
- OTHER
- label
- Group 2 : healthy volunteers
- interventionNames
- Other: Characterization of Neuromuscular Function and Fatigue
Primary outcomes (1)
- measure
- Maximal isometric muscle strength for knee extensors
- timeFrame
- At Inclusion
- description
- Measured with force sensors. Significant differences between the two groups will be assessed
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHucteau E, Mallard J, Pivot X, Schott R, Pflumio C, Trensz P, Favret F, Pagano AF, Hureau TJ. Exacerbated central fatigue and reduced exercise capacity in early-stage breast cancer patients treated with chemotherapy. Eur J Appl Physiol. 2023 Jul;123(7):1567-1581. doi: 10.1007/s00421-023-05177-5. Epub 2023 Mar 20. PMID 36939876