Neurovascular Changes Induced by Chemotherapy

Breast Cancer Clinical Trial

Official title:

Neurovascular Changes Provoked by Acute Administration Doxorubicin and Cyclophosphamide in Patients With Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03339804
• Other study ID #: SDC 4227/15/054
• Status: Completed
• Phase: N/A
• First received: October 25, 2017
• Last updated: November 7, 2017
• Start date: February 22, 2016
• Est. completion date: October 1, 2017

Study information

• Verified date: September 2017
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the present study was to test the hypothesis that doxorubicin and cyclophosphamide adjuvant chemotherapy (CHT) acutely induces neurovascular and hemodynamic changes in patients with breast cancer. To test this hypothesis, women with breast cancer (stage II-III) underwent two experimental sessions, saline (SL) and CHT. In the CHT session, doxorubicin (60 mg/m2) and cyclophosphamide (600mg/m2) were administred in 45 min. In the SL session, a matching saline volume to that of the CHT session was infused over 45 min.

Description:

The purpose of the present study was to test the hypothesis that doxorubicin and cyclophosphamide adjuvant chemotherapy (CHT) acutely induces neurovascular and hemodynamic changes in patients with breast cancer. To test this hypothesis, the patients were submitted in two experimental sessions, saline and chemotherapy, respectively. Saline Session. After fasting for 2 hours and abstaining from caffeine for 24 hours, the patients were positioned in a supine position. An intra-venous catheter was placed into the brachial venous in the contralateral arm of the breast surgery. Microelectrodes were positioned for MSNA measures in right leg, cuffs were placed around the leg for blood flow assessments and finger cuff was placed in 3 finger of hand for measurement of hemodynamic variables. After the instrumentation, an interval of 10 minutes was allowed, followed by blood sample collections for measurement of MPEs and, hemodynamic and neurovascular measures by period of 15 minutes (pre-infusion). Then, dexamethasone 20 mg and ondansetron 8 mg were administered i.v., followed by saline 0,09%, during 45 minutes. During saline infusion were continuously measured the neurovascular and hemodynamic variables. Finally, after saline administration, another blood sample was collected for MPEs dosing, followed by continuous measurement of hemodynamic and neurovacular variables by 15 minutes period (Figure 1).

Chemotherapy session. After a 2 to 3 day-interval, the patients were again positioned in a supine position in a temperature-controlled room (22oC). An intra-venous catheter was placed into the brachial venous in the contralateral arm of the breast surgery. Then, microelectrodes were positioned in the contralateral leg of the first session for MSNA measures. Likewise, cuffs were placed around the contralateral leg of the first protocol for blood flow assessments. After the instrumentation, an interval of 10 minutes was allowed, followed by blood sample collections and basal hemodynamic and neurovascular measures. Then, dexamethasone 20 mg and ondansetron 8 mg were administered, i.v., followed by doxorubicin and cyclophosphamide, during 45 minutes. During doxorubicin and cyclophosphamide infusions were continuously measured the neurovascular and hemodynamic variables. Finally, after doxorubicin plus cyclophosphamide administration, another blood sample was collected for EMPs dosing, followed by continuous measurement of hemodynamic and neurovacular variables by 15 minutes period

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 1, 2017
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 65 Years

Eligibility

Inclusion Criteria:

• Breast cancer patients and prescription of adjuvant chemotherapy with antracycline and cyclophosphamide

Exclusion Criteria:

• Metastic disease

• Hypercholesterolemia

• Diabetes

• Hypertension

• Severe lymphedema

• Renal insufficient

• Heart failure

• Chronic liver disease

• Obesity, and treatment with some medications that inhibit cardiotoxicity, as beta-blocker angiotensin converting enzyme, statin, losartan and antioxidants.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chemotherapeutic Toxicity

Intervention

Other:
• Chemotherapy
In chemoteraphy session, doxorubicin (60 mg/m2) and cyclophosphamide (600mg/m2) were administred in 45 min

Locations

Country	Name	City	State
Brazil	Heart Institute	São Paulo	Cerqueira Cesar

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hemodynamic change induced by chemoterapy	Increase of blood pressure	10 min
Primary	Neural change induced by chemoterapy	Increase of muscle nerve sympathetic activivity	10 min
Secondary	Vascular change induced by chemoterapy	Decrease of blood flow	10 min