Breast CancerPROTECT-06NCT05128617
Acute Effects of Chemotherapy Administration on Skeletal Muscle of Breast Cancer Patients: the PROTECT-06 Study
An observational study of Breast Cancer, run by Institut de cancérologie Strasbourg Europe at 1 site in France.
Trial summary
Chemotherapy treatments such as epirubicin-cyclophosphamid or paclitaxel lead to severe off-target side effects such as skeletal muscle deconditioning. To date, three different studies investigated skeletal muscle decontioning in breast cancer patients, through long term protocols including all chemotherapy cycle… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Epirubicin-cyclophosphamide and Paclitaxel
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 4 Nov 2021to 30 May 2023
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Woman recieving the first administration of epirubicin-cyclophosphamide (group 1) or paclitaxel (group 2) for early breast cancer treatment
Who may be able to join
- Breast cancer (stade I to III)
- Patient recieving the first administration of epirubicin-cyclophosphamide (group 1) or paclitaxel (group 2) for early breast cancer treatment
Who cannot join
- History of cancer
- Known chronic pathology
- Pacemaker
- Contraindication to the evaluation of the physical condition
- Contraindication to the local anesthesia for the muscle micro-biopsy
- Breastfeeding or pregnant woman
Trial locations and contacts
1 site in 1 country.
About this study
Chemotherapy treatments such as epirubicin-cyclophosphamid or paclitaxel lead to severe off-target side effects such as skeletal muscle deconditioning. To date, three different studies investigated skeletal muscle decontioning in breast cancer patients, through long term protocols including all chemotherapy cycle treatment, and highlighted both structural alterations and impaired cellular processes. However, no study is currently availbale on the acute effect of one single chemotherapy administration in breast cancer patients skeletal muscle tissue. Our study is therefore dedicated to the investigation of the acute effect of the first dose administration of both Epuribicin/cyclophosphamide and Paclitaxel chemotherapies on skeletal muscle of breast cancer patients.
Read the detailed description
Chemotherapy treatments such as epirubicin-cyclophosphamid or paclitaxel lead to severe off-target side effects such as skeletal muscle deconditioning. Resulting from a global perturbation of the muscle homeostasis, skeletal muscle is characterized by both structural and functional alterations that will translate into a decrease in muscle mass and/or force as well as an increase in muscle fatigability. These maladaptations result in a reduced quality of life and an increased treatment-related toxicity, ultimately leading to an increased mortality risk.To date, three different studies investigated skeletal muscle decontioning in breast cancer patients, through long term protocols including all chemotherapy cycle treatment, and highlighted both structural alterations and impaired cellular processes. However, no study is currently availbale on the acute effect of one single chemotherapy administration in breast cancer patients skeletal muscle tissue.Our study is therefore dedicated to the investigation of the acute effect of the first dose administration of both Epuribicin/cyclophosphamide and Paclitaxel chemotherapies on skeletal muscle of breast cancer patients. Our study will particularly explore cellular mechanisms of muscle decontioning, such as protein turnover, mitochondrial homeostasis and fatty infiltrations.
- Conditions
- Breast Cancer
- Being tested
- Epirubicin-cyclophosphamide, Paclitaxel
- Keywords
- Protein turnover, Skeletal muscle deconditoning, Breast cancer, Chemotherapy, Muscle biopsy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epirubicin-cyclophosphamideDrug
Also called Epirubicin-endoxan
1 cycle of Epirubicin-cyclophosphamide
PaclitaxelDrug
Also called Taxol
1 cycle of Paclitaxel
| Study group | Role | What they receive |
|---|---|---|
| Epirubicin-cyclophosphamide | Woman with early breast cancer receiving a first cycle of epirubicin-cyclphosphamide Receives: Drug: Epirubicin-cyclophosphamide | |
| Paclitaxel | Woman with early breast cancer receiving a first cycle of paclitaxel Receives: Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate the acute effect of chemotherapy administration on protein turnover cellular processes through vastus lateralis biopsies of breast cancer patients
Change From Baseline in Western Blots measurements of protein expression levels
Measured: Before and 4 days after the chemotherapy
Secondary outcomes (14)
Investigate the acute effect of chemotherapy administration on structural alterations
Change From Baseline in Cross-Sectional Area (CSA) measurements
Measured: Before and 4 days after the chemotherapy
Investigate the acute effect of chemotherapy administration on inflammation
Change From Baseline in Western Blots measurments of protein expression levels
Measured: Before and 4 days after the chemotherapy
Investigate the acute effect of chemotherapy administration on mitochondrial homeostasis
Change From Baseline in Western Blot measurement of protein expression levels
Measured: Before and 4 days after the chemotherapy
Investigate the acute effect of chemotherapy administration on fatty infiltrations
Change From Baseline in Western Blot measurement of protein expression levels
Measured: Before and 4 days after the chemotherapy
Investigate the acute effect of chemotherapy administration on satellite cells
Change From Baseline in Western Blot measurement of protein expression levels
Measured: Before and 4 days after the chemotherapy
.Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the skeletal muscle mass
Change From Baseline in quantity of muscle mass measured by bioelectrical impedance analysis
Measured: Before and 4 days after the chemotherapy
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the muscle force
Change From Baseline in the maximal isometric strength of the knee with force transducer
Measured: Before and 4 days after the chemotherapy
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the muscle thickness
Change From Baseline in ultrasonography measurement
Measured: Before and 4 days after the chemotherapy
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the muscle fibers angle of pennation
Change From Baseline in ultrasonography measurement
Measured: Before and 4 days after the chemotherapy
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the muscle fibers fascicle length
Change From Baseline in ultrasonography measurement
Measured: Before and 4 days after the chemotherapy
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the echogenecity
Change From Baseline in ultrasonography measurement
Measured: Before and 4 days after the chemotherapy
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the quality of life
Change From Baseline in FACT-G auto-questionnaire measurement
Measured: Before and 4 days after the chemotherapy
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the appetite loss
Change From Baseline in FAACT auto-questionnaire measurement
Measured: Before and 4 days after the chemotherapy
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the physical activity level
Change From Baseline in GPAQ auto-questionnaire measurement
Measured: Before and 4 days after the chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start4 Nov 2021
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de cancérologie Strasbourg Europe
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Strasbourg - Unité de Recherche 3072 - Mitochondries, Stress oxydant, Protection musculaire
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128617
- Sponsor's protocol ID
- 2021-004
- Acronym
- PROTECT-06
- Status last verified
- Jun 2023
- First submitted
- 4 Oct 2021
- Last updated
- 8 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Chemotherapy Administration on Skeletal Muscle of Breast Cancer Patients: the PROTECT-06 Study
- ClinicalTrials.gov ID
- NCT05128617
- Acronym / sponsor ID
- PROTECT-06 / 2021-004
- Conditions
- Breast Cancer
- Keywords
- Protein turnover, Skeletal muscle deconditoning, Breast cancer, Chemotherapy, Muscle biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Institut de cancérologie Strasbourg EuropeUniversity, hospital or other
- Collaborators
- Université de Strasbourg - Unité de Recherche 3072 - Mitochondries, Stress oxydant, Protection musculaire
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 22 Nov 2021 (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.
Chemotherapy treatments such as epirubicin-cyclophosphamid or paclitaxel lead to severe off-target side effects such as skeletal muscle deconditioning. To date, three different studies investigated skeletal muscle decontioning in breast cancer patients, through long term protocols including all chemotherapy cycle treatment, and highlighted both structural alterations and impaired cellular processes. However, no study is currently availbale on the acute effect of one single chemotherapy administration in breast cancer patients skeletal muscle tissue. Our study is therefore dedicated to the investigation of the acute effect of the first dose administration of both Epuribicin/cyclophosphamide and Paclitaxel chemotherapies on skeletal muscle of breast cancer patients.
Detailed description
Chemotherapy treatments such as epirubicin-cyclophosphamid or paclitaxel lead to severe off-target side effects such as skeletal muscle deconditioning. Resulting from a global perturbation of the muscle homeostasis, skeletal muscle is characterized by both structural and functional alterations that will translate into a decrease in muscle mass and/or force as well as an increase in muscle fatigability. These maladaptations result in a reduced quality of life and an increased treatment-related toxicity, ultimately leading to an increased mortality risk.To date, three different studies investigated skeletal muscle decontioning in breast cancer patients, through long term protocols including all chemotherapy cycle treatment, and highlighted both structural alterations and impaired cellular processes. However, no study is currently availbale on the acute effect of one single chemotherapy administration in breast cancer patients skeletal muscle tissue.Our study is therefore dedicated to the investigation of the acute effect of the first dose administration of both Epuribicin/cyclophosphamide and Paclitaxel chemotherapies on skeletal muscle of breast cancer patients. Our study will particularly explore cellular mechanisms of muscle decontioning, such as protein turnover, mitochondrial homeostasis and fatty infiltrations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epirubicin-cyclophosphamide | – | Drug: Epirubicin-cyclophosphamideWoman with early breast cancer receiving a first cycle of epirubicin-cyclphosphamide |
| Paclitaxel | – | Drug: PaclitaxelWoman with early breast cancer receiving a first cycle of paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Woman recieving the first administration of epirubicin-cyclophosphamide (group 1) or paclitaxel (group 2) for early breast cancer treatment
Key inclusion criteria (2 listed)
- Breast cancer (stade I to III)
- Patient recieving the first administration of epirubicin-cyclophosphamide (group 1) or paclitaxel (group 2) for early breast cancer treatment
Key exclusion criteria (6 listed)
- History of cancer
- Known chronic pathology
- Pacemaker
- Contraindication to the evaluation of the physical condition
- Contraindication to the local anesthesia for the muscle micro-biopsy
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 |
|---|---|---|
| Epirubicin-cyclophosphamideAlso: Epirubicin-endoxan1 cycle of Epirubicin-cyclophosphamide | Drug | Epirubicin-cyclophosphamide |
| PaclitaxelAlso: Taxol1 cycle of Paclitaxel | Drug | Paclitaxel |
Primary outcome
Investigate the acute effect of chemotherapy administration on protein turnover cellular processes through vastus lateralis biopsies of breast cancer patients
Time frame: Before and 4 days after the chemotherapy
Change From Baseline in Western Blots measurements of protein expression levels
14 secondary outcomes
Investigate the acute effect of chemotherapy administration on structural alterations
Time frame: Before and 4 days after the chemotherapy
Investigate the acute effect of chemotherapy administration on inflammation
Time frame: Before and 4 days after the chemotherapy
Investigate the acute effect of chemotherapy administration on mitochondrial homeostasis
Time frame: Before and 4 days after the chemotherapy
Investigate the acute effect of chemotherapy administration on fatty infiltrations
Time frame: Before and 4 days after the chemotherapy
Investigate the acute effect of chemotherapy administration on satellite cells
Time frame: Before and 4 days after the chemotherapy
.Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the skeletal muscle mass
Time frame: Before and 4 days after the chemotherapy
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the muscle force
Time frame: Before and 4 days after the chemotherapy
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the muscle thickness
Time frame: Before and 4 days after the chemotherapy
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the muscle fibers angle of pennation
Time frame: Before and 4 days after the chemotherapy
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the muscle fibers fascicle length
Time frame: Before and 4 days after the chemotherapy
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the echogenecity
Time frame: Before and 4 days after the chemotherapy
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the quality of life
Time frame: Before and 4 days after the chemotherapy
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the appetite loss
Time frame: Before and 4 days after the chemotherapy
Comparison of the acute effect of Epirubicin-Cyclophosphamide versus Paclitaxel on the physical activity level
Time frame: Before and 4 days after the chemotherapy
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 8 Jun 2023.
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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?
An observational study of 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 2 inclusion and 6 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 8 Jun 2023. 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?
Investigate the acute effect of chemotherapy administration on protein turnover cellular processes through vastus lateralis biopsies of breast cancer patients (time frame: Before and 4 days after the chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2023; AzTrials last refreshed its copy on 8 Nov 2026.