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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07069790
Acronym
PROTECT-08B
Enrollment
24
Registered
2025-07-17
Start date
2025-10-02
Completion date
2026-10-02
Last updated
2025-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Adenocarcinoma

Keywords

breast cancer, fatigue, muscle, heart

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.

Interventions

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.

Sponsors

Centre Paul Strauss
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Characterize the metaboreflex in breast cancer patients at the end of chemotherapy treatment3 weeks after end of chemotherapySignificant difference in mean arterial pressure, in response to a submaximal exercise, at rest and during exercise, between the two groups (patients and controls)

Secondary

MeasureTime frameDescription
Characterize the mechanoreflex in breast cancer patients at the end of chemotherapy treatment.3 weeks after end of chemotherapySignificant difference in mean arterial pressure, in response to passive leg movement, between the two groups (patients and controls)
Compare heart rate reponses to submaximal exercise between the two groups3 weeks after end of chemotherapySignificant difference in heart rate between the two groups (patients and controls)
Characterize the baroreflex in breast cancer patients at the end of chemotherapy treatment.3 weeks after end of chemotherapySignificant difference in mean arterial pressure, in response to a given stimulation of the carotid baroreceptors, at rest and during exercise, between the two groups (patients and controls)
Compare cardiac output reponses to submaximal exercise between the two groups3 weeks after end of chemotherapySignificant difference in cardiac output between the two groups (patients and controls)
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.3 weeks after end of chemotherapySignificant difference in peripheral fatigue and central fatigue between the two groups (patients and controls)
Compare stroke volume responses to submaximal exercise between the two groups3 weeks after end of chemotherapySignificant difference in stroke volume between the two groups (patients and controls)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026