Breast CancerPROTECT-07NCT06455904
Effects Of Concentric Cycling Training Protocol During (Neo)Adjuvant Chemotherapy in Breast Cancer Patients: PROTECT-07 Study
A study testing Training sessions in people with Breast Cancer, run by Centre Paul Strauss at 2 sites in France.
Trial summary
The association of anthracyclines (ANT) and paclitaxel (Tax) is one of the main treatments used in breast cancer. These treatments are known to induce severe side effects such as a decrease in overall exercise capacity (physical condition) in response to muscle and cardiorespiratory alterations. 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?
- Training sessions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 2 sitesFrance
- Study dates
- 30 May 2024to 13 Jan 2027
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman ≥ 18 years old
- Stage I to III breast cancer
- Patient currently planning (neo)adjuvant treatment combining anthracycline-cyclophosphamide and weekly paclitaxel (± trastuzumab)
- Affiliation to a social security system
- Able to speak, read and understand French
Who cannot join
- No prior chemotherapy treatment
- Any known cardiac or vascular pathology
- Contraindications to physical fitness assessment
- Protected adult
- Psychiatric, musculoskeletal or neurological problems
- Pregnant or breastfeeding woman (NB: this population is already subject to a contraindication to (neo)adjuvant treatment. For women of childbearing age, a betaHCG dosage is already carried out systematically before the start of chemotherapy and information on the need for contraception throughout the chemotherapy period is provided before the start of treatment. As part of this study, only the presence of this test with a negative result at the start of chemotherapy will be checked. inclusion, if available).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
Hôpitaux civils de Colmar
Colmar, 68024
Manon VOEGELIN
Jean-Marc LIMACHER, MD
- Recruiting
Institut de cancérologie Strasbourg Europe
Strasbourg, 67033
Manon VOEGELIN, PhD, 368339523 ext. +33, promotion-rc@icans.eu
About this study
The association of anthracyclines (ANT) and paclitaxel (Tax) is one of the main treatments used in breast cancer. These treatments are known to induce severe side effects such as a decrease in overall exercise capacity (physical condition) in response to muscle and cardiorespiratory alterations. If exercise may be an effective preventive strategy, it seems important to prescribe the most efficient exercise modality. Among them, concentric cycling (i.e., classic cycling) can significantly induce metabolic stimulus, which is needed for maintaining exercise capacity. The PROTECT-07 study aims to demonstrate the superiority of a training program based on concentric cycling during chemotherapy compared to standard treatment. The duration of the training program is 15 weeks with one session per week.
Read the detailed description
There will be two groups of patients after drawing lots using a process called randomization. The probability is one in two of being in the group participating in the training program, the other group following the standard treatment.
- Conditions
- Breast Cancer
- Being tested
- Training sessions
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training sessionsProcedure or surgery
The training program will be performed during 15 weeks, with one session per week.
| Study group | Role | What they receive |
|---|---|---|
| Training group | Experimental | This group of patients will perform concentric cycling training program during the chemotherapy treatment. Receives: Procedure: Training sessions |
| Control group | No intervention | This group of patients will benefit from standard care without additional training program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall exercise capacity
To investigate the superiority of a concentric pedaling training program during (neo)adjuvant chemotherapy versus the absence of a training program in patients with early breast cancer. The overall exercise capacity is assessed by the 6-minute walk test (TDM6) between the two groups.
Measured: At week 18 (the end of chemotherapy treatment)
Secondary outcomes (18)
Physiological variables associated with exercise capacity - cardiorespiratory capacity
To examine the effects of the training program on VO2max.
Measured: At weeks 8.
Physiological variables associated with exercise capacity - cardiorespiratory capacity
To examine the effects of the training program on VO2max.
Measured: At week 18 (the end of chemotherapy treatment)
Physiological variables associated with exercise capacity - muscle function
To examine the effects of the training program on maximal aerobic power determined as the lowest exercise intensity inducing a plateauing of O2 consumption during a maximum exercise test.
Measured: At weeks 8.
Physiological variables associated with exercise capacity - muscle function
To examine the effects of the training program on maximal aerobic power determined as the lowest exercise intensity inducing a plateauing of O2 consumption during a maximum exercise test.
Measured: At week 18 (the end of chemotherapy treatment)
Physiological variables associated with exercise capacity - body composition
To examine the effects of the training program on lean mass, fat mass, muscle mass assessed by bioimpedancemetry.
Measured: At weeks 8.
Physiological variables associated with exercise capacity - body composition
To examine the effects of the training program on lean mass, fat mass, muscle mass assessed by bioimpedancemetry.
Measured: At week 18 (the end of chemotherapy treatment)
Physiological variables associated with exercise capacity - muscle architecture
To examine the effects of the training program on muscle thickness assessed by ultrasonography.
Measured: At weeks 8.
Physiological variables associated with exercise capacity - muscle architecture
To examine the effects of the training program on fascicle length assessed by ultrasonography.
Measured: At weeks 8.
Physiological variables associated with exercise capacity - muscle architecture
To examine the effects of the training program on cross-sectional area assessed by ultrasonography.
Measured: At weeks 8.
Physiological variables associated with exercise capacity - muscle architecture
To examine the effects of the training program on muscle thickness assessed by ultrasonography.
Measured: At week 18 (the end of chemotherapy treatment)
Physiological variables associated with exercise capacity - muscle architecture
To examine the effects of the training program on fascicle length assessed by ultrasonography.
Measured: At week 18 (the end of chemotherapy treatment)
Physiological variables associated with exercise capacity - muscle architecture
To examine the effects of the training program on cross-sectional area assessed by ultrasonography.
Measured: At week 18 (the end of chemotherapy treatment)
Psychosocial variables associated with exercise capacity - quality of life
To examine the effects of the training program with the FACT-G questionnaire
Measured: At weeks 8.
Psychosocial variables associated with exercise capacity - quality of life
To examine the effects of the training program with the FACT-G questionnaire
Measured: At week 18 (the end of chemotherapy treatment)
Psychosocial variables associated with exercise capacity - fatigue
To examine the effects of the training program with the FACIT-F questionnaire
Measured: At weeks 8.
Psychosocial variables associated with exercise capacity - fatigue
To examine the effects of the training program with the FACIT-F questionnaire
Measured: At week 18 (the end of chemotherapy treatment)
Psychosocial variables associated with exercise capacity - appetite level
To examine the effects of the training program with the FAACT questionnaire
Measured: At weeks 8.
Psychosocial variables associated with exercise capacity - appetite level
To examine the effects of the training program with the FAACT questionnaire
Measured: At week 18 (the end of chemotherapy treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start30 May 2024
- Primary completion13 Jan 2027 (estimated)
- Study completion13 Jan 2027 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an interventional, randomized controlled, prospective, multicenter and adaptive study aimed at investigating the effect of a concentric pedaling training program carried out during (neo)adjuvant chemotherapy in addition to usual care.
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Paul Strauss
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BENDER Laura, MD, Principal investigator, Institut de cancérologie Strasbourg Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455904
- Sponsor's protocol ID
- 2023-005
- Acronym
- PROTECT-07
- Status last verified
- Jan 2026
- First submitted
- 30 May 2024
- Last updated
- 2 Feb 2026
- 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 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Concentric Cycling Training Protocol During (Neo)Adjuvant Chemotherapy in Breast Cancer Patients: PROTECT-07 Study
- ClinicalTrials.gov ID
- NCT06455904
- Acronym / sponsor ID
- PROTECT-07 / 2023-005
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Centre Paul StraussUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 13 Jan 2027 (estimated)
- Study completion
- 13 Jan 2027 (estimated)
- First posted
- 12 Jun 2024 (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.
The association of anthracyclines (ANT) and paclitaxel (Tax) is one of the main treatments used in breast cancer. These treatments are known to induce severe side effects such as a decrease in overall exercise capacity (physical condition) in response to muscle and cardiorespiratory alterations. If exercise may be an effective preventive strategy, it seems important to prescribe the most efficient exercise modality. Among them, concentric cycling (i.e., classic cycling) can significantly induce metabolic stimulus, which is needed for maintaining exercise capacity. The PROTECT-07 study aims to demonstrate the superiority of a training program based on concentric cycling during chemotherapy compared to standard treatment. The duration of the training program is 15 weeks with one session per week.
Detailed description
There will be two groups of patients after drawing lots using a process called randomization. The probability is one in two of being in the group participating in the training program, the other group following the standard treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an interventional, randomized controlled, prospective, multicenter and adaptive study aimed at investigating the effect of a concentric pedaling training program carried out during (neo)adjuvant chemotherapy in addition to usual care.
| Arm | Type | Receives |
|---|---|---|
| Training group | Experimental | Procedure: Training sessionsThis group of patients will perform concentric cycling training program during the chemotherapy treatment. |
| Control group | No intervention | –This group of patients will benefit from standard care without additional training program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Woman ≥ 18 years old
- Stage I to III breast cancer
- Patient currently planning (neo)adjuvant treatment combining anthracycline-cyclophosphamide and weekly paclitaxel (± trastuzumab)
- Affiliation to a social security system
- Able to speak, read and understand French
Key exclusion criteria (6 listed)
- No prior chemotherapy treatment
- Any known cardiac or vascular pathology
- Contraindications to physical fitness assessment
- Protected adult
- Psychiatric, musculoskeletal or neurological problems
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 |
|---|---|---|
| Training sessionsThe training program will be performed during 15 weeks, with one session per week. | Procedure or surgery | Training group |
Primary outcome
Overall exercise capacity
Time frame: At week 18 (the end of chemotherapy treatment)
To investigate the superiority of a concentric pedaling training program during (neo)adjuvant chemotherapy versus the absence of a training program in patients with early breast cancer. The overall exercise capacity is assessed by the 6-minute walk test (TDM6) between the two groups.
18 secondary outcomes
Physiological variables associated with exercise capacity - cardiorespiratory capacity
Time frame: At weeks 8.
Physiological variables associated with exercise capacity - cardiorespiratory capacity
Time frame: At week 18 (the end of chemotherapy treatment)
Physiological variables associated with exercise capacity - muscle function
Time frame: At weeks 8.
Physiological variables associated with exercise capacity - muscle function
Time frame: At week 18 (the end of chemotherapy treatment)
Physiological variables associated with exercise capacity - body composition
Time frame: At weeks 8.
Physiological variables associated with exercise capacity - body composition
Time frame: At week 18 (the end of chemotherapy treatment)
Physiological variables associated with exercise capacity - muscle architecture
Time frame: At weeks 8.
Physiological variables associated with exercise capacity - muscle architecture
Time frame: At weeks 8.
Physiological variables associated with exercise capacity - muscle architecture
Time frame: At weeks 8.
Physiological variables associated with exercise capacity - muscle architecture
Time frame: At week 18 (the end of chemotherapy treatment)
Physiological variables associated with exercise capacity - muscle architecture
Time frame: At week 18 (the end of chemotherapy treatment)
Physiological variables associated with exercise capacity - muscle architecture
Time frame: At week 18 (the end of chemotherapy treatment)
Psychosocial variables associated with exercise capacity - quality of life
Time frame: At weeks 8.
Psychosocial variables associated with exercise capacity - quality of life
Time frame: At week 18 (the end of chemotherapy treatment)
Psychosocial variables associated with exercise capacity - fatigue
Time frame: At weeks 8.
Psychosocial variables associated with exercise capacity - fatigue
Time frame: At week 18 (the end of chemotherapy treatment)
Psychosocial variables associated with exercise capacity - appetite level
Time frame: At weeks 8.
Psychosocial variables associated with exercise capacity - appetite level
Time frame: At week 18 (the end of chemotherapy treatment)
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 2 Feb 2026.
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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.
BENDER Laura, MD principal investigator
Institut de cancérologie Strasbourg Europe
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training sessions in people with Breast Cancer, run by Centre Paul Strauss at 2 sites 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 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: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Joris MALLARD, PhD (368767419 ext. +33, j.mallard@icans.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall exercise capacity (time frame: At week 18 (the end of chemotherapy treatment)). 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 2 Feb 2026.