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

Обзор

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.

Подробное описание

This is a cross-sectional, single-center study. It aims to compare women with breast cancer at the end of chemotherapy (Group 1 - patient group) with healthy women (with no history of cancer) matched for age, weight, and physical activity level (Group 2 - control group).

Both groups will undergo a single evaluation session lasting two hours and 25 minutes, during which cardiovascular responses and levels of neuromuscular fatigue will be assessed and compared. For the patient group, this evaluation will take place within the first three weeks following the end of chemotherapy treatment. The details and sequence of the assessments are provided in the section dedicated to the trial description.

Вмешательства

• Другое Test 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-exercis

Первичные конечные точки

• Characterize the metaboreflex in breast cancer patients at the end of chemotherapy treatment [Срок оценки: 3 weeks after end of chemotherapy]

Вторичные конечные точки (6)

• Characterize the baroreflex in breast cancer patients at the end of chemotherapy treatment. [Срок оценки: 3 weeks after end of chemotherapy]
• Characterize the mechanoreflex in breast cancer patients at the end of chemotherapy treatment. [Срок оценки: 3 weeks after end of chemotherapy]
• Compare heart rate reponses to submaximal exercise between the two groups [Срок оценки: 3 weeks after end of chemotherapy]
• Compare stroke volume responses to submaximal exercise between the two groups [Срок оценки: 3 weeks after end of chemotherapy]
• Compare cardiac output reponses to submaximal exercise between the two groups [Срок оценки: 3 weeks after end of chemotherapy]
• Compare neuromuscular responses including maximal voluntary contraction (newtons), quadriceps twitch response (newtons) and voluntary activation (% of activation) levels induced by submaximal exercise between the two groups. [Срок оценки: 3 weeks after end of chemotherapy]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Франция · 1 центр

• Institut de cancérologie Strasbourg Europe — Strasbourg

Идентификаторы

NCT: NCT07069790 · 2025-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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