Neurovascular Changes Induced by Chemotherapy

NCT ID: NCT03339804

Last Updated: 2017-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-22
• Study Completion Date: 2017-10-01

Brief 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.

Detailed 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

Conditions

Breast Cancer; Chemotherapeutic Toxicity

Keywords

Chemotherapy; Muscle sympathetic nervous activity; Blood flow; Endothelial microparticles

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Chemotherapy

Infusion of doxorubicin and cyclophosphamide

Group Type: EXPERIMENTAL

Chemotherapy

Intervention Type: OTHER

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

Interventions

Chemotherapy

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

Intervention Type: OTHER

Other Intervention Names

Doxorubicin and cyclophosphamide

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlos Negrão

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Heart Institute

São Paulo, Cerqueira Cesar, Brazil

Countries

Brazil

Other Identifiers

SDC 4227/15/054

Identifier Type: -

Identifier Source: org_study_id