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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Characterization of Neuromuscular Function and Fatigue
Sponsored by
Institut de cancérologie Strasbourg Europe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Institut de Cancerologie Strasbourg Europe

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Group 1 : Patients

Group 2 : healthy volunteers

Arm Description

Outcomes

Primary Outcome Measures

Maximal isometric muscle strength for knee extensors
Measured with force sensors. Significant differences between the two groups will be assessed

Secondary Outcome Measures

Number of Participants with neuromuscular fatigue
Assessment using surface electromyography. Significant differences between the two groups will be assessed.
Number of Participants with neuromuscular fatigue
Assessment using percutaneous electric nerve stimulation. Significant differences between the two groups will be assessed.
Number of Participants with neuromuscular fatigue
Assessment using transcranial magnetic stimulation. Significant differences between the two groups will be assessed.
Number of Participants with subjective fatigue.
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.
Assessment using muscle ultrasonography. Significant differences between the two groups will be assessed.
Number of Participants with body composition.
Assessment using bio-impedance analysis. Significant differences between the two groups will be assessed.

Full Information

First Posted
November 2, 2020
Last Updated
September 27, 2021
Sponsor
Institut de cancérologie Strasbourg Europe
Collaborators
UR 3072 - Mitochondrie, Stress oxydant et Protection musculaire
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1. Study Identification

Unique Protocol Identification Number
NCT04639609
Brief Title
Characterization of Neuromuscular Function and Fatigue After Breast Cancer Treated With Adjuvant Chemotherapy (PROTECT-04)
Acronym
PROTECT-04
Official Title
Characterization of Neuromuscular Function and Fatigue After Breast Cancer Treated With Adjuvant Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 29, 2020 (Actual)
Primary Completion Date
September 6, 2021 (Actual)
Study Completion Date
September 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de cancérologie Strasbourg Europe
Collaborators
UR 3072 - Mitochondrie, Stress oxydant et Protection musculaire

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 : Patients
Arm Type
Experimental
Arm Title
Group 2 : healthy volunteers
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Characterization of Neuromuscular Function and Fatigue
Intervention Description
at inclusion
Primary Outcome Measure Information:
Title
Maximal isometric muscle strength for knee extensors
Description
Measured with force sensors. Significant differences between the two groups will be assessed
Time Frame
At Inclusion
Secondary Outcome Measure Information:
Title
Number of Participants with neuromuscular fatigue
Description
Assessment using surface electromyography. Significant differences between the two groups will be assessed.
Time Frame
At Inclusion
Title
Number of Participants with neuromuscular fatigue
Description
Assessment using percutaneous electric nerve stimulation. Significant differences between the two groups will be assessed.
Time Frame
At Inclusion
Title
Number of Participants with neuromuscular fatigue
Description
Assessment using transcranial magnetic stimulation. Significant differences between the two groups will be assessed.
Time Frame
At Inclusion
Title
Number of Participants with subjective fatigue.
Description
Questionnaire Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F) version 4. Significant differences between the two groups will be assessed.
Time Frame
At Inclusion
Title
Number of Participants with muscle architecture.
Description
Assessment using muscle ultrasonography. Significant differences between the two groups will be assessed.
Time Frame
At Inclusion
Title
Number of Participants with body composition.
Description
Assessment using bio-impedance analysis. Significant differences between the two groups will be assessed.
Time Frame
At Inclusion

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Institut de Cancerologie Strasbourg Europe
City
Strasbourg
ZIP/Postal Code
67033
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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