Clinical Trial

Effects of Chemotherapy Treatment on Metaboreflex, Mechanoreflex, and Baroreflex Function: PROTECT-08B Study

Study acronym: PROTECT-08B
Recruiting
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-07.
Status change: Not Yet Recruiting → Recruiting 2025-12-30
Trial Details
NCT Number NCT07069790
Lead Sponsor Centre Paul Strauss
Conditions Breast Adenocarcinoma
Enrollment 24 participants
Start Date 2025-10-02
Primary Completion 2026-10-02 (estimated)
Study Completion 2026-10-02 (estimated)
Updated on ClinicalTrials.gov 2025-12-31