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

NCT ID: NCT07069790

Last Updated: 2025-12-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-02
• Study Completion Date: 2026-10-02

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.

Detailed Description

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.

Conditions

Breast Adenocarcinoma

Keywords

breast cancer; fatigue; muscle; heart

Study Design

• Allocation Method: NA
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Test of neuromuscular fatigue and associated hemodynamic responses

Group Type: EXPERIMENTAL

Test of neuromuscular fatigue and associated hemodynamic responses

Intervention Type: OTHER

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.

Interventions

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-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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Paul Strauss

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut de cancérologie Strasbourg Europe

Strasbourg, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

Laura SOMME

Role: primary

Other Identifiers

2025-001

Identifier Type: -

Identifier Source: org_study_id