NCT04554823

Brief Summary

The purpose of this study is to verify the effect of the intervention of a program of physical exercises and health education in women with breast cancer undergoing chemotherapy.

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
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

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

First Submitted

Initial submission to the registry

January 11, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

September 18, 2020

Status Verified

September 1, 2020

Enrollment Period

1.5 years

First QC Date

January 11, 2019

Last Update Submit

September 14, 2020

Conditions

Cancer, Breast

Keywords

CancerPhysical ExerciseHealth Education Program

Outcome Measures

Primary Outcomes (3)

  • Chemotherapy completion rate

    Effect of physical training on the rate of chemotherapy completion in the anthropometric profile, habitual food consumption, prevalence of comorbidities, cardiovascular, neurofunctional, bone and respiratory toxicity, myelosuppression, sarcopenia induced by chemotherapy, myalgia, nausea and vomiting symptoms.

    6 months

  • Analysis of the level of Quality of Life

    effect of physical training on the level of physical activity, perception of fatigue and pain, mood, sexual life, anxiety and depression and body image.

    6 months

  • Physical aptitude

    Effect of physical training during adjuvant and neoadjuvant chemotherapy on the levels of fragility, muscle strength, joint amplitude of the shoulder and cardiorespiratory capacity.

    6 months

Study Arms (2)

Control Group

PLACEBO COMPARATOR

Will attend lectures on health education.

Behavioral: Health EducationBehavioral: Physical Exercise

Exercise Group

EXPERIMENTAL

Will be subjected to a supervised training program of combined exercises for 24 weeks, with a frequency of 3 times weekly and duration of 60 minutes, an unsupervised flexibility training program 2 times a week and Will attend lectures on health education.

Behavioral: Health EducationBehavioral: Physical Exercise

Interventions

Health EducationBEHAVIORAL

Will attend lectures on health education about Health and Physical Education, healthy eating, overcoming barriers, Back to routine, Physical Activity Options and Dealing with Stress and Depression

Control GroupExercise Group
Physical ExerciseBEHAVIORAL

Supervised physical training program of combined exercises for 24 weeks, with frequency of 3 times weekly and duration of 60 minutes, an unsupervised flexibility training program 2 times a week.

Control GroupExercise Group

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women over 18 years of age;
  • with the first diagnosis of non-metastatic breast cancer;
  • Sedentary for 6 months;
  • who are in the initial cycle of chemotherapy;
  • with the release of the responsible physician;
  • availability to participate in the exercise program;
  • signing of the free and clarified consent term.

You may not qualify if:

  • women with clinical risk for physical exercise (e.g. severe anemia, ICC, CRI);
  • Pregnant women;
  • Osteoarticular problems that preclude the practice of physical exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Municipal Vila Santa Catarina

São Paulo, 04378500, Brazil

Location

MeSH Terms

Conditions

Breast NeoplasmsNeoplasmsMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Mayra Trevisani

    External Researcher

    STUDY CHAIR

  • Luana Queiroga

    Employee

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Verificar o efeito de um Programa de exercicios fisicos e de educacao em saude em mulheres com cancer de mama submetidas a quimioterapia sobre a taxa de conclusao da quimioterapia e sobre as toxicidades do tratamento.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2019

First Posted

September 18, 2020

Study Start

March 1, 2019

Primary Completion

September 13, 2020

Study Completion

January 31, 2023

Last Updated

September 18, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)