RecruitingNot ApplicableNCT07069790

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


Sponsor

Centre Paul Strauss

Enrollment

24 participants

Start Date

Oct 2, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at how chemotherapy for breast cancer affects the body's ability to regulate blood pressure and blood flow during and after exercise. Researchers want to compare heart and nerve function in breast cancer patients who just finished chemotherapy versus healthy women the same age. **You may be eligible if...** - You have Stage I, II, or III breast cancer - You finished chemotherapy (including pre- or post-surgery chemo) less than three weeks ago - OR you are a healthy woman with no history of cancer, similar in age, weight, and activity level to patients **You may NOT be eligible if...** - You have a history of cancer (for the healthy control group) - You have any known chronic illness - You have a pacemaker - You are pregnant - You have psychiatric, muscle, or neurological problems - You have conditions that prevent temporary blood flow restriction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERTest of neuromuscular fatigue and associated hemodynamic responses

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.


Locations(1)

Institut de cancérologie Strasbourg Europe

Strasbourg, France

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NCT07069790


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