NCT07069790 Effects of Chemotherapy Treatment on Metaboreflex, Mechanoreflex, and Baroreflex Function: PROTECT-08B Study
| NCT ID | NCT07069790 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Paul Strauss |
| Condition | Breast Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-10-02 |
| Primary Completion | 2026-10-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2025-10-02 with a primary completion date of 2026-10-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: * 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
Frequently Asked Questions
Who can join the NCT07069790 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07069790 currently recruiting?
Yes, NCT07069790 is actively recruiting participants. Visit ClinicalTrials.gov or contact Centre Paul Strauss to inquire about joining.
Where is the NCT07069790 trial being conducted?
This trial is being conducted at Strasbourg, France.
Who is sponsoring the NCT07069790 clinical trial?
NCT07069790 is sponsored by Centre Paul Strauss. The trial plans to enroll 24 participants.