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NCT Number: NCT04639609

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancerologie Strasbourg Europe

Strasbourg, 67033, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Characterization of Neuromuscular Function and Fatigue

Other

at inclusion

Primary outcomes

  1. Maximal isometric muscle strength for knee extensors

    Time frame: At Inclusion

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

Secondary outcomes

  1. Number of Participants with neuromuscular fatigue

    Time frame: At Inclusion

    Assessment using surface electromyography. Significant differences between the two groups will be assessed.

  2. Number of Participants with neuromuscular fatigue

    Time frame: At Inclusion

    Assessment using percutaneous electric nerve stimulation. Significant differences between the two groups will be assessed.

  3. Number of Participants with neuromuscular fatigue

    Time frame: At Inclusion

    Assessment using transcranial magnetic stimulation. Significant differences between the two groups will be assessed.

  4. Number of Participants with subjective fatigue.

    Time frame: At Inclusion

    Questionnaire Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F) version 4.

    Significant differences between the two groups will be assessed.

  5. Number of Participants with muscle architecture.

    Time frame: At Inclusion

    Assessment using muscle ultrasonography. Significant differences between the two groups will be assessed.

  6. Number of Participants with body composition.

    Time frame: At Inclusion

    Assessment using bio-impedance analysis. Significant differences between the two groups will be assessed.

Sponsors and collaborators

Lead sponsor

Institut de cancérologie Strasbourg Europe

Other

Collaborators

  • UR 3072 - Mitochondrie, Stress oxydant et Protection musculaire

Registry information

Official study title

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

Acronym: PROTECT-04

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 20, 2020
Registry last updated
Sep 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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