Breast AdenocarcinomaPROTECT-08BNCT07069790
Effects of Chemotherapy Treatment on Metaboreflex, Mechanoreflex, and Baroreflex Function: PROTECT-08B Study
A study testing Test of neuromuscular fatigue and associated hemodynamic responses in people with Breast Adenocarcinoma, run by Centre Paul Strauss at 1 site in France.
Trial summary
Breast cancer is the most common cancer worldwide, with over 2.2 million new cases diagnosed in 2020. Treatments such as chemotherapy often lead to a reduced exercise capacity, mainly due to cardiovascular and neuromuscular dysfunctions. 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 Adenocarcinoma
- What is being tested?
- Test of neuromuscular fatigue and associated hemodynamic responses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 2 Oct 2025to 2 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patient group :
- Stage I to III breast cancer
- Having completed (neo)adjuvant chemotherapy treatment less than three weeks ago
- Control group :
- healthy women (no history of cancer) of similar age, weight, and physical activity level
Who cannot join
- History of cancer
- Any known chronic pathology
- Protected minor or adult
- Psychiatric, musculoskeletal or neurological problems
- Implantation of a pacemaker
- Pregnant woman
- Presenting at least one contraindication to the use of transient blood flow occlusion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut de cancérologie Strasbourg Europe
Strasbourg, 67100
Laura SOMME, 0368339523, promotion-rc@icans.eu
About this study
Breast cancer is the most common cancer worldwide, with over 2.2 million new cases diagnosed in 2020. Treatments such as chemotherapy often lead to a reduced exercise capacity, mainly due to cardiovascular and neuromuscular dysfunctions. This decline appears to be primarily caused by increased central fatigue, while peripheral fatigue remains unchanged. This imbalance suggests a hyperactivation of type III-IV afferent nerve fibers, which are involved in the metaboreflex-a mechanism that significantly influences cardiovascular responses during exercise. Two non-invasive methods, post-exercise circulatory occlusion (PECO) and passive leg movement (PLM), will be used to assess this hyperactivity in patients. Additionally, baroreflex function-crucial for regulating blood pressure-will be evaluated using a direct method to determine its sensitivity and reactivity. By comparing patients with healthy controls under submaximal stimuli, this study aims to better understand chemotherapy-induced cardiovascular dysfunctions. Ultimately, the goal is to design personalized exercise programs to restore cardiovascular function and reduce treatment-related side effects.
Read the detailed description
This is a cross-sectional, single-center study. It aims to compare women with breast cancer at the end of chemotherapy (Group 1 - patient group) with healthy women (with no history of cancer) matched for age, weight, and physical activity level (Group 2 - control group).
Both groups will undergo a single evaluation session lasting two hours and 25 minutes, during which cardiovascular responses and levels of neuromuscular fatigue will be assessed and compared. For the patient group, this evaluation will take place within the first three weeks following the end of chemotherapy treatment. The details and sequence of the assessments are provided in the section dedicated to the trial description.
- Conditions
- Breast Adenocarcinoma
- Being tested
- Test of neuromuscular fatigue and associated hemodynamic responses
- Keywords
- breast cancer, fatigue, muscle, heart
- Medical subject headings
- Breast Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test of neuromuscular fatigue and associated hemodynamic responsesOther
Baseline measurements of neuromuscular function and hemodynamic responses will be performed. Baroreflex sensitivity will be assessed using a neck collar applying positive and negative pressures to stimulate the carotid baroreceptors, thereby modulating baroreflex activity in a dose-dependent manner. Mechanoreflex activation will then be evaluated using the passive leg movement (PLM) technique. After the PLM, participants will perform four fatigue tasks, each followed by 2 minutes of post-exercise circulatory occlusion (PECO). Tasks involve isometric quadriceps contractions at 20% of maximal voluntary contraction (MVC) during 1 min (block 1), 2 min (blocks 2 and 3) and until failure (block4). Neuromuscular function will be assessed through MVC changes and quadriceps twitch responses. Mean arterial pressure (MAP) will be recorded continuously. Metaboreflex activity will be determined by plotting post-PECO changes in peripheral fatigue against the change in MAP during PECO phases.
| Study group | Role | What they receive |
|---|---|---|
| Test of neuromuscular fatigue and associated hemodynamic responses | Experimental | Not described Receives: Other: Test of neuromuscular fatigue and associated hemodynamic responses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the metaboreflex in breast cancer patients at the end of chemotherapy treatment
Significant difference in mean arterial pressure, in response to a submaximal exercise, at rest and during exercise, between the two groups (patients and controls)
Measured: 3 weeks after end of chemotherapy
Secondary outcomes (6)
Characterize the baroreflex in breast cancer patients at the end of chemotherapy treatment.
Significant difference in mean arterial pressure, in response to a given stimulation of the carotid baroreceptors, at rest and during exercise, between the two groups (patients and controls)
Measured: 3 weeks after end of chemotherapy
Characterize the mechanoreflex in breast cancer patients at the end of chemotherapy treatment.
Significant difference in mean arterial pressure, in response to passive leg movement, between the two groups (patients and controls)
Measured: 3 weeks after end of chemotherapy
Compare heart rate reponses to submaximal exercise between the two groups
Significant difference in heart rate between the two groups (patients and controls)
Measured: 3 weeks after end of chemotherapy
Compare stroke volume responses to submaximal exercise between the two groups
Significant difference in stroke volume between the two groups (patients and controls)
Measured: 3 weeks after end of chemotherapy
Compare cardiac output reponses to submaximal exercise between the two groups
Significant difference in cardiac output between the two groups (patients and controls)
Measured: 3 weeks after end of chemotherapy
Compare neuromuscular responses including maximal voluntary contraction (newtons), quadriceps twitch response (newtons) and voluntary activation (% of activation) levels induced by submaximal exercise between the two groups.
Significant difference in peripheral fatigue and central fatigue between the two groups (patients and controls)
Measured: 3 weeks after end of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start2 Oct 2025
- Primary completion2 Oct 2026 (estimated)
- Study completion2 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast AdenocarcinomaStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Paul Strauss
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069790
- Sponsor's protocol ID
- 2025-001
- Acronym
- PROTECT-08B
- Status last verified
- Dec 2025
- First submitted
- 5 Jun 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chemotherapy Treatment on Metaboreflex, Mechanoreflex, and Baroreflex Function: PROTECT-08B Study
- ClinicalTrials.gov ID
- NCT07069790
- Acronym / sponsor ID
- PROTECT-08B / 2025-001
- Conditions
- Breast Adenocarcinoma
- Keywords
- breast cancer, fatigue, muscle, heart
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Centre Paul StraussUniversity, hospital or other
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- 2 Oct 2026 (estimated)
- Study completion
- 2 Oct 2026 (estimated)
- First posted
- 17 Jul 2025 (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.
Breast cancer is the most common cancer worldwide, with over 2.2 million new cases diagnosed in 2020. Treatments such as chemotherapy often lead to a reduced exercise capacity, mainly due to cardiovascular and neuromuscular dysfunctions. This decline appears to be primarily caused by increased central fatigue, while peripheral fatigue remains unchanged. This imbalance suggests a hyperactivation of type III-IV afferent nerve fibers, which are involved in the metaboreflex-a mechanism that significantly influences cardiovascular responses during exercise. Two non-invasive methods, post-exercise circulatory occlusion (PECO) and passive leg movement (PLM), will be used to assess this hyperactivity in patients. Additionally, baroreflex function-crucial for regulating blood pressure-will be evaluated using a direct method to determine its sensitivity and reactivity. By comparing patients with healthy controls under submaximal stimuli, this study aims to better understand chemotherapy-induced cardiovascular dysfunctions. Ultimately, the goal is to design personalized exercise programs to restore cardiovascular function and reduce treatment-related side effects.
Detailed description
This is a cross-sectional, single-center study. It aims to compare women with breast cancer at the end of chemotherapy (Group 1 - patient group) with healthy women (with no history of cancer) matched for age, weight, and physical activity level (Group 2 - control group).
Both groups will undergo a single evaluation session lasting two hours and 25 minutes, during which cardiovascular responses and levels of neuromuscular fatigue will be assessed and compared. For the patient group, this evaluation will take place within the first three weeks following the end of chemotherapy treatment. The details and sequence of the assessments are provided in the section dedicated to the trial description.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test of neuromuscular fatigue and associated hemodynamic responses | Experimental | Other: Test of neuromuscular fatigue and associated hemodynamic responses |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Stage I to III breast cancer
- Having completed (neo)adjuvant chemotherapy treatment less than three weeks ago
- healthy women (no history of cancer) of similar age, weight, and physical activity level
Key exclusion criteria (7 listed)
- History of cancer
- Any known chronic pathology
- Protected minor or adult
- Psychiatric, musculoskeletal or neurological problems
- Implantation of a pacemaker
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 |
|---|---|---|
| Test of neuromuscular fatigue and associated hemodynamic responsesBaseline measurements of neuromuscular function and hemodynamic responses will be performed. Baroreflex sensitivity will be assessed using a neck collar applying positive and negative pressures to stimulate the carotid baroreceptors, thereby modulating baroreflex activity in a dose-dependent manner. Mechanoreflex activation will then be evaluated using the passive leg movement (PLM) technique. After the PLM, participants will perform four fatigue tasks, each followed by 2 minutes of post-exercise circulatory occlusion (PECO). Tasks involve isometric quadriceps contractions at 20% of maximal voluntary contraction (MVC) during 1 min (block 1), 2 min (blocks 2 and 3) and until failure (block4). Neuromuscular function will be assessed through MVC changes and quadriceps twitch responses. Mean arterial pressure (MAP) will be recorded continuously. Metaboreflex activity will be determined by plotting post-PECO changes in peripheral fatigue against the change in MAP during PECO phases. | Other | Test of neuromuscular fatigue and associated hemodynamic responses |
Primary outcome
Characterize the metaboreflex in breast cancer patients at the end of chemotherapy treatment
Time frame: 3 weeks after end of chemotherapy
Significant difference in mean arterial pressure, in response to a submaximal exercise, at rest and during exercise, between the two groups (patients and controls)
6 secondary outcomes
Characterize the baroreflex in breast cancer patients at the end of chemotherapy treatment.
Time frame: 3 weeks after end of chemotherapy
Characterize the mechanoreflex in breast cancer patients at the end of chemotherapy treatment.
Time frame: 3 weeks after end of chemotherapy
Compare heart rate reponses to submaximal exercise between the two groups
Time frame: 3 weeks after end of chemotherapy
Compare stroke volume responses to submaximal exercise between the two groups
Time frame: 3 weeks after end of chemotherapy
Compare cardiac output reponses to submaximal exercise between the two groups
Time frame: 3 weeks after end of chemotherapy
Compare neuromuscular responses including maximal voluntary contraction (newtons), quadriceps twitch response (newtons) and voluntary activation (% of activation) levels induced by submaximal exercise between the two groups.
Time frame: 3 weeks after end of chemotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test of neuromuscular fatigue and associated hemodynamic responses in people with Breast Adenocarcinoma, run by Centre Paul Strauss 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 31 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize the metaboreflex in breast cancer patients at the end of chemotherapy treatment (time frame: 3 weeks after end of 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 31 Dec 2025.