Clinical trial · Interventional
Effects of Chemotherapy Treatment on Metaboreflex, Mechanoreflex, and Baroreflex Function: PROTECT-08B Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Adenocarcinoma | Breast Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Test of neuromuscular fatigue and associated hemodynamic responses | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Test of neuromuscular fatigue and associated hemodynamic responses
- interventionNames
- Other: Test of neuromuscular fatigue and associated hemodynamic responses
Primary outcomes (1)
- measure
- Characterize the metaboreflex in breast cancer patients at the end of chemotherapy treatment
- timeFrame
- 3 weeks after end of chemotherapy
- description
- Significant difference in mean arterial pressure, in response to a submaximal exercise, at rest and during exercise, between the two groups (patients and controls)
Secondary outcomes (6)
- measure
- Characterize the baroreflex in breast cancer patients at the end of chemotherapy treatment.
- timeFrame
- 3 weeks after end of chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available