Neurovascular Changes Induced by Chemotherapy

NCT03339804 | Completed DMC

• 1 other identifier: SDC 4227/15/054
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Chemotherapeutic Toxicity

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Neural change induced by chemoterapy

  Increase of muscle nerve sympathetic activivity

  10 min

Secondary Outcomes (1)

• Vascular change induced by chemoterapy

  10 min

Other Outcomes (1)

• Hemodynamic change induced by chemoterapy

  10 min

Study Arms (1)

Chemotherapy

EXPERIMENTAL

Infusion of doxorubicin and cyclophosphamide

Other: Chemotherapy

Interventions

Chemotherapy OTHER

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

Also known as: Doxorubicin and cyclophosphamide

Chemotherapy

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Heart Institute

São Paulo, Cerqueira Cesar, Brazil

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Drug Therapy; Doxorubicin; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Study Officials

• Carlos Negrão

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: November 13, 2017
• Study Start: February 22, 2016
• Primary Completion: December 1, 2016
• Study Completion: October 1, 2017
• Last Updated: November 13, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)