NCT04047901

Brief Summary

New therapies for cancer increased patient survival, but led to the recognition of adverse effects associated with cancer treatment, such as the use of chemotherapy. Cardiotoxicity is the most significant adverse effect, which affect the functional capacity and quality of life and is associated with high morbidity and mortality, regardless of the oncological prognosis. One of the manifestations of cardiotoxicity is ventricular dysfunction that can lead to heart failure. Neuro humoral hyperactivation with increased sympathetic nerve activity is a typical manifestation of heart failure and is associated with worse prognosis. Studies have shown that physical training significantly reduces sympathetic nerve activity in addition to improving muscle blood flow, reversing effects on skeletal muscle and improving quality of life. The hypothesis is that physical training may reduce sympathetic nerve activity and vasoconstrictor status in patients with heart failure caused by anthracyclines, as well as improving baroreflex and chemoreflex sensibility, mechanoreflex and metaborreflex control and skeletal myopathy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 7, 2016

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 7, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

August 7, 2019

Status Verified

March 1, 2019

Enrollment Period

4.2 years

First QC Date

March 29, 2019

Last Update Submit

August 5, 2019

Conditions

Insufficiency;CardiacCancerCardiotoxicityHeart Failure

Keywords

autonomic dysfunctionbaroreflex controlergorreflex controlmuscle myopaty

Outcome Measures

Primary Outcomes (1)

  • Measure muscular sympathetic nervous activity

    The sympathetic nervous activity is assessed by the microneurography technique

    16 weeks

Secondary Outcomes (5)

  • Evaluate baroreflex activity

    16 weeks

  • Evaluate quimiorreflex sensibility

    16 weeks

  • Evaluate Mecanorreflex control

    16 weeks

  • Evaluate metaborreflex control

    16 weeks

  • Evaluation of skeletal myopathy

    16 weeks

Study Arms (2)

control group

NO INTERVENTION

A group of patients who will not be trained will be evaluated at baseline (pre) and after 16 weeks. They are oriented to maintain lifestyle changes

Training group

EXPERIMENTAL

Patients will complete 16 weeks of training including 40 minutes of aerobic training, 15 minutes of resistive exercise and 5 minutes of relaxation.

Other: exercise training

Interventions

exercise trainingOTHER

Patients undergo 16 weeks of physical training

Training group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 years old
  • Funcional Class I-III (NYHA)
  • Ejection fraction \< o,55
  • treated for heart failure

You may not qualify if:

  • Coronary artery disease
  • Moderate to major valve disease
  • Positive serology for Chagas
  • Inability to perform physical exercises

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Institute of University of São Paulo

São Paulo, São Paulo, 05403-900, Brazil

RECRUITING

MeSH Terms

Conditions

Heart FailureNeoplasmsCardiotoxicityPrimary Dysautonomias

Interventions

Exercise

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and InjuriesAutonomic Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Amanda Gonzales Rodrigues

CONTACT

+55(11)999468264amanda.rodrigues@incor.usp.br

Carlos Eduardo Negrao, PHD

CONTACT

+55(11)26615043

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2019

First Posted

August 7, 2019

Study Start

November 7, 2016

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

August 7, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)