Breast CancerPROTECT-05NCT05166148
Consequences of Eccentric Cycling on Exercise-related Neuromuscular Responses and Biomarkers in Breast Cancer Patients
A study testing Session (a), Session (b) and Session (c) in people with Breast Cancer, run by Institut de cancérologie Strasbourg Europe at 1 site in France.
Trial summary
This is a monocentric, prospective and interventional study aimed to investigating the physiological responses of eccentric compared to concentric cycling realized 1) at the same metabolic demand and 2) at the same mechanical power output. 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?
- Session (a), Session (b) and Session (c)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 22 Nov 2021to 28 Apr 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman who completed (neo)adjuvant chemotherapy since less than 1 year for a breast cancer
- Woman under hormonotherapy, or menopausal woman, or woman in amenorrhea
Who cannot join
- Pregnant and nursing woman
- psychiatric, musculoskeletal or neurological disorders
- presenting at least one contraindication to the use of the transcranial magnetic stimulation
- presenting at least one contraindication to the realisation of the maximum effort test
Trial locations and contacts
1 site in 1 country.
About this study
This is a monocentric, prospective and interventional study aimed to investigating the physiological responses of eccentric compared to concentric cycling realized 1) at the same metabolic demand and 2) at the same mechanical power output. In order to compare the physiological responses between these two cycling modalities, 3 cycling sessions should be performed for each patient where concentric one will serve as reference / comparison to the eccentric one:
- Session (a): eccentric cycling
- Session (b): high intensity concentric cycling realized at the same mechanical power output than eccentric cycling
- Session (c): low intensity concentric cycling realized at the same metabolic demand than eccentric cycling The 3 sessions will be performed for each patient and order will be randomized.
Read the detailed description
For each participant, 10 visits will be realized as followed:
Visit 1: determination of maximal O2 consumption (VO2max) and first familiarization session to eccentric cycling Visits 2, 3 and 4: second, third and fourth eccentric cycling familiarization sessions Visits 5, 7 and 9: cycling sessions (a), (b) and (c) attributed in a random order Visits 6, 8 and 10: post-24h measurements after cycling sessions
- Conditions
- Breast Cancer
- Being tested
- Session (a), Session (b), Session (c)
- Keywords
- Breast Cancer, Eccentric Cycling, Physiological Responses
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Session (a)Other
Eccentric cycling
Session (b)Other
High intensity concentric cycling realized at the same mechanical power output than eccentric cycling
Session (c)Other
Low intensity concentric cycling realized at the same metabolic demand than eccentric cycling
| Study group | Role | What they receive |
|---|---|---|
| eccentric cycling compared to concentric cycling | Experimental | Every participant will perform the same protocol and will participated to the 3 experimental sessions (a, b and c) of the assigned intervention. Receives: Other: Session (a); Other: Session (b); Other: Session (c) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate the physiological responses of the eccentric cycling on the knee extensors muscles by changes of neuromuscular parameters
Measurement of neuromuscular fatigue via change in maximal voluntary isometric contraction of the knee extensors muscles registered via a force sensor.
Measured: 24 hours after pedaling sessions
Secondary outcomes (8)
Comparison of muscle pain after eccentric in session (a) and after concentric modalities in session (b) and session (c)
Measurement of muscle pain by visual analog scale (VAS) consists of a 100 mm long line providing a range of score from 0-100 (0: no pain, 100: worst possible pain).
Measured: 24 hours after pedaling sessions
Comparison of central (identified as a decrease in voluntary activation, VA) fatigue after eccentric in session (a) and after concentric modalities in session (b) and session (c)
Measurement of central fatigue by percutaneous neurostimulation applied during the maximal voluntary contraction to evidence the level of voluntary activation (VA in %) and by transcranial magnetic stimulation to evidenced level of corticospinal excitability (measured by the MEP visible on EMG activity).
Measured: 24 hours after pedaling sessions
Comparison of peripheral (identified as a decrease in the quadriceps twitch muscle contractile capacities, Qtw) fatigue after eccentric in session (a) and after concentric modalities in session (b) and session (c)
Measurement of peripheral fatigue by percutaneous neurostimulation applied at rest to evoked quadriceps twitch force (Qtw) to evidence muscle contractile properties.
Measured: 24 hours after pedaling sessions
Comparison of muscle thickness measured via ultrasonography on the vastus lateralis muscle after eccentric modality in pedaling session (a) and after concentric modalities in pedaling sessions (b) and (c)
Change from baseline by ultrasonography measurements in the muscle thickness of the vastus lateralis muscle. Muscle thickness was measured as the distance from the superior border of the superficial aponeurosis and the superior border of the deep aponeurosis.
Measured: 24 hours after pedaling sessions
Comparison of muscle fibers pennation angle measured via ultrasonography on the vastus lateralis muscle after eccentric modality in pedaling session (a) and after concentric modalities in pedaling sessions (b) and (c)
Change from baseline by ultrasonography measurements in the pennation angle of the vastus lateralis muscle. Pennation angle was measured as the angle between a fiber and the deep aponeurosis.
Measured: 24 hours after pedaling sessions
Comparison of muscle fibers fascile length measured via ultrasonography on the vastus lateralis muscle after eccentric modality in pedaling session (a) and after concentric modalities in pedaling sessions (b) and (c)
Change from baseline by ultrasonography measurements in the fascicle length of the vastus lateralis muscle. Fascicle length was measured as the distance of a fibers between its insertion on the superficial aponeurosis and its insertions on the deep aponeurosis.
Measured: 24 hours after pedaling sessions
Comparison of muscle echogenecity measured via ultrasonography on the vastus lateralis muscle after eccentric modality in pedaling session (a) and after concentric modalities in pedaling sessions (b) and (c)
Change from baseline by ultrasonography measurements in echogenecity of the vastus lateralis muscle. Echo intensity was determined based on the gray scale analysis of each pixel, the corresponding index of muscle quality ranging between 0 and 255 arbitrary units.
Measured: 24 hours after pedaling sessions
Comparison of blood markers in session (a) and after concentric modalities in session (b) and session (c)
Change from baseline of blood markers dosage. Blood markers dosage investigated will: Reactive oxygen species (ROS), carbonylated protein, lipid peroxidation, antioxidant enzyme, proinflammatory cytokines, and muscle damage markers (creatine kinase, lactate dehydrogenase).
Measured: 24 hours after pedaling sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start22 Nov 2021
- Primary completion28 Apr 2022
- Study completion28 Apr 2022
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de cancérologie Strasbourg Europe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland SCHOTT, MD, Principal investigator, Institut de cancérologie Strasbourg Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166148
- Sponsor's protocol ID
- 2021-005
- Acronym
- PROTECT-05
- Status last verified
- May 2022
- First submitted
- 24 Nov 2021
- Last updated
- 26 May 2022
- 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 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consequences of Eccentric Cycling on Exercise-related Neuromuscular Responses and Biomarkers in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05166148
- Acronym / sponsor ID
- PROTECT-05 / 2021-005
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Eccentric Cycling, Physiological Responses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Institut de cancérologie Strasbourg EuropeUniversity, hospital or other
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 28 Apr 2022 (actual)
- Study completion
- 28 Apr 2022 (actual)
- First posted
- 21 Dec 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.
This is a monocentric, prospective and interventional study aimed to investigating the physiological responses of eccentric compared to concentric cycling realized 1) at the same metabolic demand and 2) at the same mechanical power output. In order to compare the physiological responses between these two cycling modalities, 3 cycling sessions should be performed for each patient where concentric one will serve as reference / comparison to the eccentric one:
- Session (a): eccentric cycling
- Session (b): high intensity concentric cycling realized at the same mechanical power output than eccentric cycling
- Session (c): low intensity concentric cycling realized at the same metabolic demand than eccentric cycling The 3 sessions will be performed for each patient and order will be randomized.
Detailed description
For each participant, 10 visits will be realized as followed:
Visit 1: determination of maximal O2 consumption (VO2max) and first familiarization session to eccentric cycling Visits 2, 3 and 4: second, third and fourth eccentric cycling familiarization sessions Visits 5, 7 and 9: cycling sessions (a), (b) and (c) attributed in a random order Visits 6, 8 and 10: post-24h measurements after cycling sessions
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eccentric cycling compared to concentric cycling | Experimental | Other: Session (a), Other: Session (b), Other: Session (c)Every participant will perform the same protocol and will participated to the 3 experimental sessions (a, b and c) of the assigned intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Woman who completed (neo)adjuvant chemotherapy since less than 1 year for a breast cancer
- Woman under hormonotherapy, or menopausal woman, or woman in amenorrhea
Key exclusion criteria (4 listed)
- Pregnant and nursing woman
- psychiatric, musculoskeletal or neurological disorders
- presenting at least one contraindication to the use of the transcranial magnetic stimulation
- presenting at least one contraindication to the realisation of the maximum effort test
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 |
|---|---|---|
| Session (a)Eccentric cycling | Other | eccentric cycling compared to concentric cycling |
| Session (b)High intensity concentric cycling realized at the same mechanical power output than eccentric cycling | Other | eccentric cycling compared to concentric cycling |
| Session (c)Low intensity concentric cycling realized at the same metabolic demand than eccentric cycling | Other | eccentric cycling compared to concentric cycling |
Primary outcome
Investigate the physiological responses of the eccentric cycling on the knee extensors muscles by changes of neuromuscular parameters
Time frame: 24 hours after pedaling sessions
Measurement of neuromuscular fatigue via change in maximal voluntary isometric contraction of the knee extensors muscles registered via a force sensor.
8 secondary outcomes
Comparison of muscle pain after eccentric in session (a) and after concentric modalities in session (b) and session (c)
Time frame: 24 hours after pedaling sessions
Comparison of central (identified as a decrease in voluntary activation, VA) fatigue after eccentric in session (a) and after concentric modalities in session (b) and session (c)
Time frame: 24 hours after pedaling sessions
Comparison of peripheral (identified as a decrease in the quadriceps twitch muscle contractile capacities, Qtw) fatigue after eccentric in session (a) and after concentric modalities in session (b) and session (c)
Time frame: 24 hours after pedaling sessions
Comparison of muscle thickness measured via ultrasonography on the vastus lateralis muscle after eccentric modality in pedaling session (a) and after concentric modalities in pedaling sessions (b) and (c)
Time frame: 24 hours after pedaling sessions
Comparison of muscle fibers pennation angle measured via ultrasonography on the vastus lateralis muscle after eccentric modality in pedaling session (a) and after concentric modalities in pedaling sessions (b) and (c)
Time frame: 24 hours after pedaling sessions
Comparison of muscle fibers fascile length measured via ultrasonography on the vastus lateralis muscle after eccentric modality in pedaling session (a) and after concentric modalities in pedaling sessions (b) and (c)
Time frame: 24 hours after pedaling sessions
Comparison of muscle echogenecity measured via ultrasonography on the vastus lateralis muscle after eccentric modality in pedaling session (a) and after concentric modalities in pedaling sessions (b) and (c)
Time frame: 24 hours after pedaling sessions
Comparison of blood markers in session (a) and after concentric modalities in session (b) and session (c)
Time frame: 24 hours after pedaling sessions
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 26 May 2022.
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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.
Roland SCHOTT, MD principal investigator
Institut de cancérologie Strasbourg Europe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Session (a), Session (b) and Session (c) 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 2 inclusion and 4 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 26 May 2022. 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 physiological responses of the eccentric cycling on the knee extensors muscles by changes of neuromuscular parameters (time frame: 24 hours after pedaling sessions). 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 26 May 2022.