Chemotherapy effects on reflexes that control muscle responses and blood pressure during exercise
Effects of Chemotherapy Treatment on Metaboreflex, Mechanoreflex, and Baroreflex Function: PROTECT-08B Study
NA · Centre Paul Strauss · NCT07069790
This test will see if women finishing chemotherapy for breast cancer have overactive muscle reflexes and altered blood-pressure control that reduce exercise ability compared with similar healthy women.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Centre Paul Strauss (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT07069790 on ClinicalTrials.gov |
What this trial studies
This single-center, cross-sectional study compares women with stage I–III breast cancer who have completed (neo)adjuvant chemotherapy within the past three weeks to age-, weight-, and activity-matched healthy women. Each participant completes a single 2 hour 25 minute session during which neuromuscular fatigue tests and cardiovascular measurements are performed. Non-invasive probes—post-exercise circulatory occlusion (PECO) and passive leg movement (PLM)—are used to probe metaboreflex and mechanoreflex activity, and a direct method is used to measure baroreflex sensitivity. The study compares reflex-driven cardiovascular responses and fatigue profiles between patients and controls to clarify chemotherapy-related changes.
Who should consider this trial
Good fit: Women with stage I–III breast cancer who completed (neo)adjuvant chemotherapy less than three weeks ago, with no major chronic, psychiatric, musculoskeletal, or neurological conditions, are the intended participants.
Not a fit: Women with a history of other cancers, chronic medical conditions, implanted pacemakers, pregnancy, or contraindications to transient blood-flow occlusion are not eligible and would not benefit from participation.
Why it matters
Potential benefit: If successful, the results could help design targeted rehabilitation or protective strategies to reduce fatigue and improve exercise capacity after chemotherapy.
How similar studies have performed: Previous research has linked chemotherapy to increased central fatigue and altered cardiovascular reflexes, but combining PECO, PLM, and direct baroreflex measures in this patient group is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Strasbourg
- Institut de cancérologie Strasbourg Europe — Strasbourg, France (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Adenocarcinoma, breast cancer, fatigue, muscle, heart