Breast CancerPROTECT-04NCT04639609
Characterization of Neuromuscular Function and Fatigue After Breast Cancer Treated With Adjuvant Chemotherapy (PROTECT-04)
A study testing Characterization of Neuromuscular Function and Fatigue in people with Breast Cancer, run by Institut de cancérologie Strasbourg Europe at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Characterization of Neuromuscular Function and Fatigue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 29 Sep 2020to 6 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- Group 2 - Control group :
- Give written inform consent
- Age ≥ 18 years
- Affiliate to social security system
- Ability to speak, understand and read French
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization of Neuromuscular Function and Fatigue After Breast Cancer Treated With Adjuvant Chemotherapy
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Characterization of Neuromuscular Function and Fatigue
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Characterization of Neuromuscular Function and FatigueOther
at inclusion
| Study group | Role | What they receive |
|---|---|---|
| Group 1 : Patients | Experimental | Not described Receives: Other: Characterization of Neuromuscular Function and Fatigue |
| Group 2 : healthy volunteers | Other | Not described Receives: Other: Characterization of Neuromuscular Function and Fatigue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal isometric muscle strength for knee extensors
Measured with force sensors. Significant differences between the two groups will be assessed
Measured: At Inclusion
Secondary outcomes (6)
Number of Participants with neuromuscular fatigue
Assessment using surface electromyography. Significant differences between the two groups will be assessed.
Measured: At Inclusion
Number of Participants with neuromuscular fatigue
Assessment using percutaneous electric nerve stimulation. Significant differences between the two groups will be assessed.
Measured: At Inclusion
Number of Participants with neuromuscular fatigue
Assessment using transcranial magnetic stimulation. Significant differences between the two groups will be assessed.
Measured: At Inclusion
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.
Measured: At Inclusion
Number of Participants with muscle architecture.
Assessment using muscle ultrasonography. Significant differences between the two groups will be assessed.
Measured: At Inclusion
Number of Participants with body composition.
Assessment using bio-impedance analysis. Significant differences between the two groups will be assessed.
Measured: At Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start29 Sep 2020
- Primary completion6 Sep 2021
- Study completion6 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de cancérologie Strasbourg Europe
- Sponsor type
- University, hospital or other
- Collaborators
- UR 3072 - Mitochondrie, Stress oxydant et Protection musculaire
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639609
- Sponsor's protocol ID
- 2020-007
- Other IDs
- 2020-A01272-37
- Acronym
- PROTECT-04
- Status last verified
- Sep 2021
- First submitted
- 2 Nov 2020
- Last updated
- 28 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36939876
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Neuromuscular Function and Fatigue After Breast Cancer Treated With Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT04639609
- Acronym / sponsor ID
- PROTECT-04 / 2020-007
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Institut de cancérologie Strasbourg EuropeUniversity, hospital or other
- Collaborators
- UR 3072 - Mitochondrie, Stress oxydant et Protection musculaire
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- 6 Sep 2021 (actual)
- Study completion
- 6 Sep 2021 (actual)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 : Patients | Experimental | Other: Characterization of Neuromuscular Function and Fatigue |
| Group 2 : healthy volunteers | Other | Other: Characterization of Neuromuscular Function and Fatigue |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (21 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Characterization of Neuromuscular Function and Fatigueat inclusion | Other | Group 1 : Patients, Group 2 : healthy volunteers |
Primary outcome
Maximal isometric muscle strength for knee extensors
Time frame: At Inclusion
Measured with force sensors. Significant differences between the two groups will be assessed
6 secondary outcomes
Number of Participants with neuromuscular fatigue
Time frame: At Inclusion
Number of Participants with neuromuscular fatigue
Time frame: At Inclusion
Number of Participants with neuromuscular fatigue
Time frame: At Inclusion
Number of Participants with subjective fatigue.
Time frame: At Inclusion
Number of Participants with muscle architecture.
Time frame: At Inclusion
Number of Participants with body composition.
Time frame: At Inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Derived from this study: PubMed 36939876Hucteau 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Characterization of Neuromuscular Function and Fatigue in people with Breast Cancer, run by Institut de cancérologie Strasbourg Europe at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal isometric muscle strength for knee extensors (time frame: At Inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04639609, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.