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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCentre Paul Strauss

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Stage I to III breast cancer

Having completed (neo)adjuvant chemotherapy treatment less than three weeks ago

Disqualifiers

History of cancer

Any known chronic pathology

Protected minor or adult

Psychiatric, musculoskeletal or neurological problems

Trial design

Design model

Parallel

Treatments tested in this trial

  • Test of neuromuscular fatigue and associated hemodynamic responses

    Other intervention

    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.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Test of neuromuscular fatigue and associated hemodynamic responsesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Characterize the metaboreflex in breast cancer patients at the end of chemotherapy treatment

Significant difference in mean arterial pressure, in response to a submaximal exercise, at rest and during exercise, between the two groups (patients and controls)

Time frame
3 weeks after end of chemotherapy

Secondary outcomes

1

Characterize the baroreflex in breast cancer patients at the end of chemotherapy treatment.

Significant 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)

Time frame
3 weeks after end of chemotherapy
2

Characterize the mechanoreflex in breast cancer patients at the end of chemotherapy treatment.

Significant difference in mean arterial pressure, in response to passive leg movement, between the two groups (patients and controls)

Time frame
3 weeks after end of chemotherapy
3

Compare heart rate reponses to submaximal exercise between the two groups

Significant difference in heart rate between the two groups (patients and controls)

Time frame
3 weeks after end of chemotherapy
4

Compare stroke volume responses to submaximal exercise between the two groups

Significant difference in stroke volume between the two groups (patients and controls)

Time frame
3 weeks after end of chemotherapy

Other outcomes

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