NCT04639609

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 29, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 2, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 20, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2021

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

11 months

First QC Date

November 2, 2020

Last Update Submit

September 27, 2021

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Maximal isometric muscle strength for knee extensors

    Measured with force sensors. Significant differences between the two groups will be assessed

    At Inclusion

Secondary Outcomes (6)

  • Number of Participants with neuromuscular fatigue

    At Inclusion

  • Number of Participants with neuromuscular fatigue

    At Inclusion

  • Number of Participants with neuromuscular fatigue

    At Inclusion

  • Number of Participants with subjective fatigue.

    At Inclusion

  • Number of Participants with muscle architecture.

    At Inclusion

  • +1 more secondary outcomes

Study Arms (2)

Group 1 : Patients

EXPERIMENTAL
Other: Characterization of Neuromuscular Function and Fatigue

Group 2 : healthy volunteers

OTHER
Other: Characterization of Neuromuscular Function and Fatigue

Interventions

Characterization of Neuromuscular Function and FatigueOTHER

at inclusion

Group 1 : PatientsGroup 2 : healthy volunteers

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Cancerologie Strasbourg Europe

Strasbourg, 67033, France

Location

Related Publications (1)

  • Hucteau 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: 36939876DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2020

First Posted

November 20, 2020

Study Start

September 29, 2020

Primary Completion

September 6, 2021

Study Completion

September 6, 2021

Last Updated

September 28, 2021

Record last verified: 2021-09

Locations

FR(1)