Clinical trial · Interventional
Effect of Anthracyclines and Cyclophosphamide on Cardiovascular Responses
Chronic Effect of Doxorubicin and Cyclophosphamide on Neurovascular Control and Blood Pressure in Women in Adjuvant Treatment for Breast Neoplasia
NCT04568161CI-TRIAL-00088060completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The present study aims to investigate the chronic effect of treatment with doxorubicin and cyclophosphamide on neurovascular control and blood pressure in women undergoing adjuvant treatment for breast cancer.
Conditions
Conditions (5)
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cardiotoxicity | — | UNRESOLVED | — |
| Cardiovascular Disease | — | UNRESOLVED | — |
| Endothelial Disfunction | — | UNRESOLVED | — |
| Neurovascular Disorder | — | UNRESOLVED | — |
Interventions
Interventions (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anthracycline & Cyclophosphamide treatment scheme | Drug | — | UNRESOLVED |
| Blood Assessments | Diagnostic Test | — | UNRESOLVED |
| Blood pressure | Diagnostic Test | — | UNRESOLVED |
| Cardiac Function | Diagnostic Test | — | UNRESOLVED |
| Endothelium-dependent vascular function | Diagnostic Test | — | UNRESOLVED |
| Heart rate | Diagnostic Test | — | UNRESOLVED |
| Muscle blood flow | Diagnostic Test | — | UNRESOLVED |
| Muscular Sympathetic Nervous Activity | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- pre and post chemotherapy assessments
- description
- The patients will be assessed before and after chemotherapy treatment.
- interventionNames
- Procedure: Physical Characteristics
- Procedure: Muscular Sympathetic Nervous Activity
- Diagnostic Test: Cardiac Function
- Diagnostic Test: Heart rate
- Diagnostic Test: Blood pressure
- Diagnostic Test: Blood Assessments
- Diagnostic Test: Muscle blood flow
- Diagnostic Test: Endothelium-dependent vascular function
- Diagnostic Test: Vascular intima-media thickness
- Diagnostic Test: Physical Capacity
- Drug: Anthracycline & Cyclophosphamide treatment scheme
Primary outcomes (1)
- measure
- Muscle sympathetic nerve activity
- timeFrame
- 15-20 days after the end of AC regimen
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * diagnosis of stage II-III breast cancer * starting adjuvant chemotherapy Exclusion Criteria: * metastatic disease, * hypercholesterolemia, diabetes, * hypertension, * severe lymphedema, * organic disorders (renal failure, heart failure and chronic liver disease), * obesity (BMI\> 30) and, * who are under pharmacological treatment with statins, angiotensin-converting enzyme inhibitors, losartan potassium, beta blockers or antioxidants
References
Publications (14)
- BACKGROUNDSiegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA Cancer J Clin. 2019 Jan;69(1):7-34. doi: 10.3322/caac.21551. Epub 2019 Jan 8. PMID 30620402
- BACKGROUNDPai VB, Nahata MC. Cardiotoxicity of chemotherapeutic agents: incidence, treatment and prevention. Drug Saf. 2000 Apr;22(4):263-302. doi: 10.2165/00002018-200022040-00002. PMID 10789823
- BACKGROUNDDolci A, Dominici R, Cardinale D, Sandri MT, Panteghini M. Biochemical markers for prediction of chemotherapy-induced cardiotoxicity: systematic review of the literature and recommendations for use. Am J Clin Pathol. 2008 Nov;130(5):688-95. doi: 10.1309/AJCPB66LRIIVMQDR. PMID 18854260
- BACKGROUNDJensen BV, Skovsgaard T, Nielsen SL. Functional monitoring of anthracycline cardiotoxicity: a prospective, blinded, long-term observational study of outcome in 120 patients. Ann Oncol. 2002 May;13(5):699-709. doi: 10.1093/annonc/mdf132. PMID 12075737
- BACKGROUNDSales ARK, Negrao MV, Testa L, Ferreira-Santos L, Groehs RVR, Carvalho B, Toschi-Dias E, Rocha NG, Laurindo FRM, Debbas V, Rondon MUPB, Mano MS, Hajjar LA, Hoff PMG, Filho RK, Negrao CE. Chemotherapy acutely impairs neurovascular and hemodynamic responses in women with breast cancer. Am J Physiol Heart Circ Physiol. 2019 Jul 1;317(7):H1-H12. doi: 10.1152/ajpheart.00756.2018. Epub 2019 Apr 19. PMID 31002284
- BACKGROUNDSoultati A, Mountzios G, Avgerinou C, Papaxoinis G, Pectasides D, Dimopoulos MA, Papadimitriou C. Endothelial vascular toxicity from chemotherapeutic agents: preclinical evidence and clinical implications. Cancer Treat Rev. 2012 Aug;38(5):473-83. doi: 10.1016/j.ctrv.2011.09.002. Epub 2011 Oct 6. PMID 21982720
- BACKGROUNDLaterza MC, de Matos LD, Trombetta IC, Braga AM, Roveda F, Alves MJ, Krieger EM, Negrao CE, Rondon MU. Exercise training restores baroreflex sensitivity in never-treated hypertensive patients. Hypertension. 2007 Jun;49(6):1298-306. doi: 10.1161/HYPERTENSIONAHA.106.085548. Epub 2007 Apr 16.